ADC Name	Telisotuzumab vedotin
Synonyms	telisotuzumab vedotin; ABBV-399; Teliso-V; telisotuzumab vedotin-tllv; Emrelis    Click to Show/Hide
Organization	AbbVie (Top20 MNC) (Originator)
Drug Status	Approved in 2025
Drug-to-Antibody Ratio	3.1
Structure
	3D MOL			2D MOL
Antibody Name	Telisotuzumab					Antibody Info
Antigen Name	Hepatocyte growth factor receptor (MET)					Antigen Info
Payload Name	Monomethyl auristatin E					Payload Info
Payload Target	Microtubule (MT)					Target Info
Linker Name	Mc-Val-Cit-PABC					Linker Info
Conjugate Type	Random Cysteines
Combination Type	vedotin
Special Approval(s)	Breakthrough therapy (FDA)

Standard Type	Value	Units	Description	Reference
Maximum Observed Concentration (Cmax)	57	ug/mL	Preliminary Pharmacokinetic Parameters (Geometric Mean [%CV]) for Teliso-V Conjugate Following 2.7-mg/kg Q3W Dose in Combination With Erlotinib.	[1]
Time to Maximum Concentration (Tmax)	1	h	Preliminary Pharmacokinetic Parameters (Geometric Mean [%CV]) for Teliso-V Conjugate Following 2.7-mg/kg Q3W Dose in Combination With Erlotinib.	[1]
Area Under the Concentration-Time Curve (AUC)	4048	ug·h/mL	Preliminary Pharmacokinetic Parameters (Geometric Mean [%CV]) for Teliso-V Conjugate Following 2.7-mg/kg Q3W Dose in Combination With Erlotinib, AUCinf.	[1]
Time to Maximum Concentration (Tmax)	1	h	Summary of teliso-v pharmacokinetics, Cycle 1, 2.4 mg/kg, n=3.	[2]
Maximum Observed Concentration (Cmax)	55.5	ug/mL	Summary of teliso-v pharmacokinetics, Cycle 1, 2.4 mg/kg, n=3.	[2]
Area Under the Concentration-Time Curve (AUC)	4437	ug·h/mL	Summary of teliso-v pharmacokinetics, Cycle 1, 2.4 mg/kg, n=3, AUCinf.	[2]
Time to Maximum Concentration (Tmax)	1	h	Summary of teliso-v pharmacokinetics, Cycle 1, 2.7 mg/kg, n=6.	[2]
Maximum Observed Concentration (Cmax)	63	ug/mL	Summary of teliso-v pharmacokinetics, Cycle 1, 2.7 mg/kg, n=6.	[2]
Area Under the Concentration-Time Curve (AUC)	5202	ug·h/mL	Summary of teliso-v pharmacokinetics, Cycle 1, 2.7 mg/kg, n=6, AUCinf.	[2]
Time to Maximum Concentration (Tmax)	1	h	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.6 mg/kg.	[3]
Maximum Observed Concentration (Cmax)	23.1	ug/mL	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.6 mg/kg.	[3]
Area Under the Concentration-Time Curve (AUC)	1510	ug·h/mL	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.6 mg/kg, AUCtau.	[3]
Time to Maximum Concentration (Tmax)	1	h	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.9 mg/kg.	[3]
Maximum Observed Concentration (Cmax)	29.6	ug/mL	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.9 mg/kg.	[3]
Area Under the Concentration-Time Curve (AUC)	1950	ug·h/mL	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.9 mg/kg, AUCtau.	[3]
Maximum Observed Concentration (Cmax)	29	ug/mL	The maximum concentration (Cmax) of telisotuzumab vedotin occurs at the end of intravenous infusion and is approximately 29 ug/mL.	[4]
Maximum Observed Concentration (Cmax)	2.2	ng/mL	The maximum concentration of unconjugated MMAE occurs approximately 5 days after administration and is approximately 2.2 ng/mL.	[4]
Area Under the Concentration-Time Curve (AUC)	2130	ug·h/mL	The AUC0-tau of telisotuzumab vedotin and MMAE are 2130 ug·h/mL and 405 ng·h/mL, respectively.	[4]

Standard Type	Value	Units	Description	Reference
Volume of Distribution (Vd)	3.4	L	The volume of distribution of telisotuzumab vedotin is 3.4 liters.	[4]

Standard Type	Value	Units	Description	Reference
Undisclosed	Undisclosed	Undisclosed	Telisotuzumab vedotin metabolism has not been studied in humans. The antibody component is likely broken down to smaller peptides and amino acids, while the drug component is metabolized primarily by CYP3A4.    Click to Show/Hide	[4]

Standard Type	Value	Units	Description	Reference
Elimination Half-Life (t1/2)	4.18	day	Summary of teliso-v pharmacokinetics, Cycle 1, 2.4 mg/kg, n=3.	[2]
Elimination Half-Life (t1/2)	2.91	day	Summary of teliso-v pharmacokinetics, Cycle 1, 2.7 mg/kg, n=6.	[2]
Elimination Half-Life (t1/2)	2.68	day	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.6 mg/kg.	[3]
Elimination Half-Life (t1/2)	2.88	day	Preliminary Teliso-V conjugate PK parameters following Q2W Teliso-V infusion in cycle 1, 1.9 mg/kg.	[3]
Elimination Half-Life (t1/2)	3	day	The elimination half-life of telisotuzumab vedotin is approximately 3 days, and the elimination half-life of MMAE is approximately 4 days.	[4]
Clearance (CL)	1.3	L/day	The estimated clearance of telisotuzumab vedotin is 1.3 liters/day	[4]
Clearance (CL)	76	L/day	The estimated clearance of unconjugated MMAE is 76 liters/day	[4]

Standard Type	NCT Number	Clinical Status	Clinical Trial Description
Progression Free Survival	NCT03574753	PHASE2	A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Objective Response Rate (ORR)	NCT03574753	PHASE2	A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Objective Response Rate (ORR)	NCT03539536	PHASE2	Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Disease control rate (DCR)	NCT02099058	PHASE1	A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Undisclosed	NCT04928846	PHASE3	A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer    Click to Show/Hide
Undisclosed	NCT05513703	PHASE2	Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Undisclosed	NCT06093503	PHASE3	Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment    Click to Show/Hide
Undisclosed	NCT06568939	PHASE2	A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer    Click to Show/Hide
Undisclosed	NCT04830202	N.A.	Expanded Access to Telisotuzumab Vedotin
Undisclosed	NCT03311477	PHASE1	A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
Undisclosed	NCT06068842	N.A.	International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer
Objective Response Rate (ORR)	NCT02099058	Phase 1	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Objective Response Rate (ORR)	NCT02099058	Phase 1	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Objective Response Rate (ORR)	NCT02099058	Phase 1	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Objective Response Rate (ORR)	NCT02099058	Phase 1	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Objective Response Rate (ORR)	NCT01638936	Phase 1	A phase 1/2a multi-dose escalation study of BT062 in combination with lenalidomide or pomalidomide and dexamethasone in subjects with relapsed or relapsed/refractory multiple myeloma.
Objective Response Rate (ORR)	NCT01472016	Phase 1	A multi-center, phase 1/1b, open-label, dose escalation study of ABT-700, a monoclonal antibody in subjects with advanced solid tumors.
Undisclosed	NCT01915472	Phase 2	A phase 2 study of IMMU 130 (hmn-14-SN38 antibody drug conjugate) in patients with metastatic colorectal cancer.
Undisclosed	NCT01001442	Phase 1/2	A phase 1/2a multi-dose escalation study to evaluate maximum tolerated dose (MTD), pharmacokinetics (PK), safety and efficacy of BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.    Click to Show/Hide
Undisclosed	NCT01270698	Phase 1	A phase 1 study of IMMU-130 (hmn-14-SN38 antibody drug conjugate) in patients with colorectal cancer.
Undisclosed	NCT01605318	Phase 1	A phase 1/2 study of once or twice weekly IMMU-130 (hMN-14-SN38, antibody-drug conjugate) in patients with colorectal cancer.
Undisclosed	NCT00723359	Phase 1	A phase 1 dose escalation study to evaluate maximum tolerated dose (MTD), pharmacokinetics (PK), and safety of BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.
Undisclosed	NCT02099058	Phase 1	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.

Experiment 1 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Progression Free Survival	5.9 months
Patients Enrolled	Eligibility requires c-Met+ SCCA with no prior immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4) or autoimmune disease (exceptions: vitiligo, stable endocrine disorders). Exclusions: active HBV/HIV, chronic HCV, interstitial lung disease, NYHA Class III/IV cardiac conditions, recent corticosteroids (>10mg prednisone/day), or allergies to nivolumab/ipilimumab. Cardiac dysfunction (CHF/MI within 6 months) mandates cardiology evaluation. PRO questionnaires (English) are mandatory pre-registration.    Click to Show/Hide
Administration Dosage	ABBV-399 (Process II), 2.7 mg/kg IV over 30 minutes, Day 1, Every 21 days
Related Clinical Trial
NCT Number	NCT03574753	Clinical Status	PHASE2
Clinical Description	A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Primary Endpoint	Primary efficacy outcomes include overall response rate (ORR; confirmed/unconfirmed CR/PR per RECIST 1.1) in c-Met+ lung squamous cell carcinoma (SCCA) patients. Safety metrics focus on Grade 3-5 drug-related adverse events (CTCAE v4.0/5.0) during treatment and 3-year follow-up.
Other Endpoint	Secondary endpoints evaluate immunotherapy-exposed/relapsed c-Met+ SCCA: investigator-assessed progression-free survival (IA-PFS; time to progression/symptomatic deterioration/death), overall survival (OS; time to death), and ORR per RECIST 1.1 over 3 years. Duration of response (DoR; time from initial response to progression/death) is also measured.    Click to Show/Hide
Experiment 2 Reporting the Activity Date of This ADC					[1]
Efficacy Data	Objective Response Rate (ORR)	32.1 52.6 %
Patients Enrolled	Eligibility requires c-Met+ SCCA with no prior immune checkpoint inhibitor (anti-PD-1/PD-L1/CTLA-4) or autoimmune disease (exceptions: vitiligo, stable endocrine disorders). Exclusions: active HBV/HIV, chronic HCV, interstitial lung disease, NYHA Class III/IV cardiac conditions, recent corticosteroids (>10mg prednisone/day), or allergies to nivolumab/ipilimumab. Cardiac dysfunction (CHF/MI within 6 months) mandates cardiology evaluation. PRO questionnaires (English) are mandatory pre-registration.    Click to Show/Hide
Administration Dosage	ABBV-399 (Process II), 2.7 mg/kg IV over 30 minutes, Day 1, Every 21 days
Related Clinical Trial
NCT Number	NCT03574753	Clinical Status	PHASE2
Clinical Description	A Phase II Study of ABBV-399 in Patients With C-Met Positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP SUB-STUDY)
Primary Endpoint	Primary efficacy outcomes include overall response rate (ORR; confirmed/unconfirmed CR/PR per RECIST 1.1) in c-Met+ lung squamous cell carcinoma (SCCA) patients. Safety metrics focus on Grade 3-5 drug-related adverse events (CTCAE v4.0/5.0) during treatment and 3-year follow-up.
Other Endpoint	Secondary endpoints evaluate immunotherapy-exposed/relapsed c-Met+ SCCA: investigator-assessed progression-free survival (IA-PFS; time to progression/symptomatic deterioration/death), overall survival (OS; time to death), and ORR per RECIST 1.1 over 3 years. Duration of response (DoR; time from initial response to progression/death) is also measured.    Click to Show/Hide
Experiment 3 Reporting the Activity Date of This ADC					[5]
Efficacy Data	Objective Response Rate (ORR)	36.50%
Patients Enrolled	Eligible participants must have c-Met+ locally advanced/metastatic non-squamous EGFR-wildtype NSCLC (&le;2 prior systemic therapies including &le;1 cytotoxic chemotherapy line) with ECOG 0-1. Exclusions include recent lung radiation (<6 months), adenosquamous histology, ILD/pneumonitis history (no evidence on screening imaging for Ireland sites), active infections (HIV/HBV/HCV - specific to France/CZ sites), and unresolved Grade&ge;2 toxicities (except alopecia/anemia). Stable CNS metastases post-definitive therapy are permitted.    Click to Show/Hide
Administration Dosage	Telisotuzumab vedotin administered via intravenous (IV) infusion every 14 days.
Related Clinical Trial
NCT Number	NCT03539536	Clinical Status	PHASE2
Clinical Description	Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Primary Endpoint	Key efficacy endpoints include overall response rate (ORR; confirmed CR/PR per RECIST v1.1) and adverse events assessment in the alternate dose cohort over approximately 3 years.
Other Endpoint	Additional efficacy measures comprise duration of response (DoR; time from initial response to progression/death), disease control rate (DCR; CR+PR+SD≥12 weeks), progression-free survival (PFS; time from first dose to progression/death), and overall survival (OS; time from first dose to death) - all assessed over approximately 3 years.
Experiment 4 Reporting the Activity Date of This ADC					[6]
Efficacy Data	Disease control rate (DCR)	76.90%
Patients Enrolled	Eligible patients have advanced NSCLC (ECOG 0-2) with measurable disease and adequate organ function. Exclusions: recent lung radiation (<6 months), uncontrolled CNS metastases, ILD/pneumonitis history, unresolved Grade&ge;2 toxicities, major surgery within 21 days, or active COVID-19. Combination-specific exclusions apply (e.g., QTc>470ms for osimertinib arm; autoimmune disease/immunosuppressants for nivolumab arm).    Click to Show/Hide
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT02099058	Clinical Status	PHASE1
Clinical Description	A Multicenter, Phase 1/1b, Open-Label, Dose-Escalation Study of ABBV-399, an Antibody Drug Conjugate, in Subjects With Advanced Solid Tumors
Primary Endpoint	Primary outcomes assess safety (adverse events over 24 months) and pharmacokinetics of ABBV-399 (monotherapy/combination with osimertinib/erlotinib/nivolumab) including recommended Phase 2 dose (RPTD), AUC (0-t), Cmax, Tmax, and terminal half-life.
Other Endpoint	Efficacy endpoints include objective response rate (ORR; CR/PR per RECIST 1.1), progression-free survival (PFS; time from first dose to progression/death), and duration of response (DoR; time from initial response to progression) over 24 months.
Experiment 5 Reporting the Activity Date of This ADC					[7]
Patients Enrolled	Eligible participants must have c-Met-overexpressing non-squamous NSCLC (confirmed by AbbVie's IHC assay), actionable gene alterations (if applicable), measurable disease (RECIST v1.1), ECOG 0-1, and &le;1 prior cytotoxic chemotherapy line in advanced/metastatic setting. Exclusions include untreated CNS metastases, prior c-Met/EGFR-targeted therapy, docetaxel exposure, idiopathic pulmonary fibrosis, unresolved Grade &ge;2 toxicities (except alopecia/anemia), major surgery within 21 days, or protocol-specified comorbidities. Stable brain metastases post-treatment are allowed if asymptomatic and off steroids (&le;10mg prednisone/day).    Click to Show/Hide
Administration Dosage	Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Related Clinical Trial
NCT Number	NCT04928846	Clinical Status	PHASE3
Clinical Description	A Phase 3 Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Versus Docetaxel in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Primary Endpoint	Efficacy evaluation includes progression-free survival (PFS) and overall survival (OS) assessed up to 39 months via Blinded Independent Central Review (BICR) and investigator assessment, with PFS defined as time from randomization to radiographic progression (RECIST v1.1) or death, and OS as time to death from any cause.
Other Endpoint	Additional efficacy measures comprise objective response rate (ORR) and duration of response (DoR) per BICR (up to 58.25 months), alongside quality-of-life changes (EORTC QLQ-C30) over 12 weeks, assessing physical function and global health status on a 0-100 scale where higher scores indicate better functioning/quality of life or worse symptom burden.    Click to Show/Hide
Experiment 6 Reporting the Activity Date of This ADC					[8]
Patients Enrolled	Eligible participants must have MET-amplified non-squamous NSCLC (central lab-confirmed), measurable disease (RECIST v1.1), ECOG 0-1, and prior adjuvant/neoadjuvant therapy completed &ge;6 months pre-enrollment. Exclusions include actionable EGFR/ALK/ROS1/BRAF alterations, prior metastatic NSCLC systemic therapy (except &le;1 chemotherapy cycle), unresolved Grade &ge;2 toxicities (excluding alopecia/anemia), major surgery within 21 days, or protocol-specified comorbidities (e.g., active pneumonitis). Stable CNS metastases post-treatment are permitted.    Click to Show/Hide
Administration Dosage	Participants will receive telisotuzumab vedotin every 2 weeks until meeting study drug discontinuation criteria.
Related Clinical Trial
NCT Number	NCT05513703	Clinical Status	PHASE2
Clinical Description	Phase 2, Open-Label Study in Subjects With Previously Untreated MET Amplified Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Primary Endpoint	Efficacy outcomes include objective response rate (ORR) per Independent Central Review (ICR) up to 1 year, defined as confirmed complete (CR) or partial response (PR) by RECIST v1.1, alongside duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) up to 2 years.
Other Endpoint	Patient-reported outcomes assess time to deterioration in cough, pain, dyspnea, and physical function (EORTC QLQ-LC13/QLQ-C30) and quality-of-life changes (EORTC QLQ-C30 Global Health Status) over 1 year, scored 0-100 (higher scores indicate better function/QoL or worse symptoms).
Experiment 7 Reporting the Activity Date of This ADC					[9]
Patients Enrolled	Eligible participants must have EGFR-mutated (del19/L858R &plusmn;T790M), c-Met-overexpressing non-squamous NSCLC (IHC-confirmed), ECOG 0-1, measurable disease (RECIST v1.1), and progression on prior third-generation EGFR TKI (e.g., osimertinib). Exclusions include actionable ALK/ROS1/BRAF alterations, prior metastatic chemotherapy (except limited platinum pre-TKI), unresolved Grade &ge;2 toxicities (excluding alopecia/anemia), major surgery within 21 days, active pneumonitis, or protocol-specified comorbidities (e.g., uncontrolled infections, &ge;Grade 2 edema/neuropathy). Stable CNS metastases post-definitive therapy are permitted if asymptomatic for &ge;4 weeks.    Click to Show/Hide
Administration Dosage	Participants will receive telisotuzumab vedotin every 2 weeks in combination with osimertinib, until disease progression or unacceptable toxicity.
Related Clinical Trial
NCT Number	NCT06093503	Clinical Status	PHASE3
Clinical Description	Phase 3, Open-Label, Randomized, Controlled, Global Study of Telisotuzumab Vedotin (ABBV-399) Combined With Osimertinib vs Platinum-Based Chemotherapy in Subjects With c-Met Overexpressing (OE) EGFR Mutant, Locally Advanced/Metastatic Non-Squamous NSCLC After a First Progression on Prior Third Generation EGFR TKi Treatment
Primary Endpoint	The study evaluates progression-free survival (PFS) both in participants without CNS metastases and in the overall population, defined as time from randomization to radiographic progression (RECIST v1.1) or death. Overall response (OR) and duration of response (DoR) are similarly assessed, with OR defined as confirmed complete (CR) or partial response (PR), and DoR measuring time from response to progression or death.    Click to Show/Hide
Other Endpoint	Secondary outcomes include overall survival (OS) and changes in physical functioning/quality of life using EORTC QLQ-C30 and QLQ-LC13 scales (0-100), where higher scores indicate better function/QoL or worse symptoms. Adverse events (AEs) are monitored up to 41 months, with causality assessed by investigators.
Experiment 8 Reporting the Activity Date of This ADC					[10]
Patients Enrolled	Eligible participants must have c-Met-overexpressing NSCLC (IHC-confirmed), ECOG 0-1, measurable disease (RECIST v1.1), and &le;1 prior cytotoxic chemotherapy line. Exclusions include actionable EGFR mutations, prior c-Met-targeted ADCs/docetaxel, active pneumonitis, unresolved Grade&ge;2 toxicities (excluding alopecia/anemia), major surgery within 21 days, or protocol-specified comorbidities (e.g., &ge;Grade 2 edema/neuropathy, uncontrolled infections). Stable CNS metastases post-therapy are permitted if asymptomatic.    Click to Show/Hide
Administration Dosage	Participants will receive telisotuzumab vedotin dose A/B, as part of the 3 year study duration.
Related Clinical Trial
NCT Number	NCT06568939	Clinical Status	PHASE2
Clinical Description	A Phase 2, Open-Label, Randomized, Global Study of Two Telisotuzumab Vedotin Regimens in Subjects With Previously Treated c-Met Overexpressing, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer
Primary Endpoint	Safety endpoints include treatment-emergent adverse events (AEs) (any-grade/Grade≥2), specifically interstitial lung disease (ILD), peripheral neuropathy, and ocular surface disorders (corneal epitheliopathy) over 3 years, along with AEs leading to treatment discontinuation or Grade 5 (fatal) events. Efficacy measures include objective response (OR: CR/PR per RECIST v1.1) and duration of response (DoR) assessed by blinded independent central review (BICR).    Click to Show/Hide
Other Endpoint	Pharmacokinetic analyses measure telisotuzumab vedotin conjugate (serum) and MMAE payload (plasma) concentrations over 26 weeks, alongside antidrug antibody (ADA/nADA) incidence. Patient-reported outcomes assess treatment tolerability via PRO-CTCAE (0-4 scale) and FACT-G GP5 item. Secondary endpoints include PFS (time to progression/death) and OS (time to death) over 3 years.    Click to Show/Hide
Experiment 9 Reporting the Activity Date of This ADC					[11]
Patients Enrolled	The participant must not be eligible for a telisotuzumab vedotin clinical trial.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT04830202	Clinical Status	N.A.
Clinical Description	Expanded Access to Telisotuzumab Vedotin
Experiment 10 Reporting the Activity Date of This ADC					[12]
Patients Enrolled	Eligible participants must have histologically confirmed advanced solid tumors (ECOG 0-2) with measurable disease, archived tumor tissue, and adequate organ function. Exclusions: prior anticancer therapy within 21 days (7 days for herbal), uncontrolled brain metastases (eligible post-definitive therapy if asymptomatic without steroids/anticonvulsants for &ge;2 weeks), unresolved Grade&ge;2 toxicities (except alopecia/anemia), or major surgery within 21 days.    Click to Show/Hide
Administration Dosage	ABBV-399 via intravenous administration at escalating dose levels.
Related Clinical Trial
NCT Number	NCT03311477	Clinical Status	PHASE1
Clinical Description	A Phase I Study to Evaluate the Safety and Pharmacokinetics of ABBV-399 in Japanese Subjects With Advanced Solid Tumors
Primary Endpoint	Pharmacokinetic parameters include AUC (0-t), Cmax, Tmax, and terminal elimination half-life (t1/2), measured over 24 months. Dose determination evaluates Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) as the highest dose with <33% dose-limiting toxicities in the first 21 days.
Other Endpoint	Efficacy outcomes measured over 24 months are Progression-Free Survival (PFS; time from first dose to progression/death), Objective Response Rate (ORR; confirmed CR/PR by RECIST 1.1), and Duration of Response (DOR; initial response to progression/death).
Experiment 11 Reporting the Activity Date of This ADC					[13]
Patients Enrolled	Eligible participants must have confirmed advanced/metastatic NSQ NSCLC, available FFPE tissue collected since 2019, and prior consent for biomarker research. Exclusions: pre-2019 specimens, inadequate tissue volume/quality (e.g., <4-5um thickness), and adenosquamous/sarcomatous histologies.
Administration Dosage	.
Related Clinical Trial
NCT Number	NCT06068842	Clinical Status	N.A.
Clinical Description	International Real-World Study of MET Overexpression in Patients With Non-Small Cell Lung Cancer
Primary Endpoint	MET protein overexpression status (either positive [≥25% tumor cells with 3+ staining] or high-positive [≥50% tumor cells with 3+ staining]) will be assessed via local IHC testing over 15 months.
Experiment 12 Reporting the Activity Date of This ADC					[14]
Efficacy Data	Objective Response Rate (ORR)	7.40%
Patients Enrolled	Advanced non-small cell lung cancer (NSCLC).
Administration Dosage	Teliso-V Q2W (1.60, 1.90, or 2.20 mg/kg, intravenous) with nivolumab (3 mg/kg, or 240 mg, or per locally approved label, intravenously).
Related Clinical Trial
NCT Number	NCT02099058	Clinical Status	Phase 1
Clinical Description	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Primary Endpoint	Most patients (97.30%, n=36) experienced one or more TEAE, with 23 (62.16%) reporting TEAEs grades 3 or higher. TEAEs considered possibly related to Teliso-V were reported in 78.38% (n=29) of patients; 32.43% (n=12) were grade greater than or equal to 3.
Other Endpoint	Combination therapy with Teliso-V plus nivolumab was well tolerated in patients with c-Met-+NSCLC with limited antitumor activity. The ORR was 7.40% (95% CI: 0.90-24.30), with two patients (PD-L1+, n =1; PD-L1-, n=1) having a confirmed PR.Overall, 66.67% of patients (16 of 24) had evidence of tumor size reduction; three (12.5%) reported a greater than 30% reduction in target lesion. The overall median PFS (95% CI) was 7.20 months (3.30-8.90); 7.20 months(1.50-not reached [NR]) for PD-L1 patients, 4.50 months(1.50-NR) for PD-L1- patients, and NR (2.00-NR) for PD-L1-unk patients. The objective response rate was 7.40%, with two patients having a confirmed partial response. Overall median progression-free survival was 7.20 months.    Click to Show/Hide
Experiment 13 Reporting the Activity Date of This ADC					[15]
Efficacy Data	Objective Response Rate (ORR)	23.00 28.00 18.00 18.00 31.00 6.00 43.00 %
Patients Enrolled	Non-small cell lung cancer (NSCLC) and c-Met H-score 150 (c-Met+) or MET amplification/exon 14 skipping mutations.
Administration Dosage	Intravenously once every 3 weeks (0.15-3.30 mg/kg) or once every 2 weeks (1.60-2.20 mg/kg).
Related Clinical Trial
NCT Number	NCT02099058	Clinical Status	Phase 1
Clinical Description	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Primary Endpoint	Four objective responses (ORR = 26.70%; 95% CI, 7.80-55.10) were observed in this subgroup, 3 in once every 2 weeks (ORR = 43.00%; 95% CI, 9.90-81.60), and 1 in once every 3 weeks (ORR = 13.00%; 95% CI, 0.30-52.70).
Other Endpoint	The median PFS in once every 2 weeks cohorts was 8.00 months (range, 1.20-9.10) and the median treatment duration was 19.60 weeks (range, 0.10-60.10).
Experiment 14 Reporting the Activity Date of This ADC					[16]
Efficacy Data	Objective Response Rate (ORR)	30.55 32.10 52.60 %
Patients Enrolled	Advanced non-small cell lung cancer (measurable per Response Evaluation Criteria in Solid Tumors v1.1) not amenable to resection or other approved therapies until disease progression, death, or withdrawal of consent.
Administration Dosage	Teliso-V (2.70 mg/kg once every 21 days) plus erlotinib (150 mg once daily) until disease progression, death, or withdrawal of consent.
Related Clinical Trial
NCT Number	NCT02099058	Clinical Status	Phase 1
Clinical Description	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Primary Endpoint	OrR for all efficacy-evaluable patients was 30.55% (11/36; 95% CI, 16.30 to 48.10), and DCR was 86.11% (31/36; 95% CI, 70.5 to 95.3). Median PFS for all efficacy-evaluable patients was 5.90 months (95% CI, 2.80 to not reached [NR]).
Other Endpoint	For EGFR-M+ patients (n = 28), ORR was 32.14% (9/28; 95% CI, 15.90 to 52.40), with one CR (3.57%) and eight PR (28.57%). DCR was 85.71% (24/28; 95% CI, 67.30 to 96.00) and median PFS was 5.90 months (95% CI, 2.80 to NR). Median PFS was 3.70 months (95% CI, 1.40 to NR) for T790M+ patients, compared with 6.80 months (95% CI, 4.30 to NR) for non-T790M+ patients. Of EGFR-M+ patients, those who were c-Met high (n = 15) had an ORR of 52.60%. Median PFS was 6.80 months for non-T790M+ and for those whose T790M status was unknown, versus 3.70 months for T790M+.    Click to Show/Hide
Experiment 15 Reporting the Activity Date of This ADC					[16]
Efficacy Data	Objective Response Rate (ORR)	30.60 32.18 52.60 %
Patients Enrolled	Advanced non-small cell lung cancer (measurable per Response Evaluation Criteria in Solid Tumors v1.1) not amenable to resection or other approved therapies until disease progression, death, or withdrawal of consent.
Administration Dosage	Teliso-V (2.70 mg/kg once every 21 days) plus erlotinib (150 mg once daily) until disease progression, death, or withdrawal of consent.
Related Clinical Trial
NCT Number	NCT02099058	Clinical Status	Phase 1
Clinical Description	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Primary Endpoint	Median PFS=5.90 months (95% CI, 2.80 to not reached). ORR for EGFR-M+ patients = 32.18% (n=28). EGFR-M+ patients ORR = 52.60%.
Other Endpoint	Median PFS=6.80 months for non-T790M+.
Experiment 16 Reporting the Activity Date of This ADC					[17]
Efficacy Data	Objective Response Rate (ORR)	71.70 70.60 %
Patients Enrolled	Relapsed or refractory multiple myeloma, and ECOG performance status or Zubrod score of 2 or below, received indatuximab ravtansine with lenalidomide and dexamethasone (indatuximab ravtansine plus lenalidomide) had failure of at least one previous therapy.
Administration Dosage	Intravenously on days 1, 8, and 15 of each 28-day cycle in dose of 100 mg/m2 plus lenalidomide or pomalidomide and dexamethasone.
Related Clinical Trial
NCT Number	NCT01638936	Clinical Status	Phase 1
Clinical Description	A phase 1/2a multi-dose escalation study of BT062 in combination with lenalidomide or pomalidomide and dexamethasone in subjects with relapsed or relapsed/refractory multiple myeloma.
Experiment 17 Reporting the Activity Date of This ADC					[18]
Efficacy Data	Objective Response Rate (ORR)	75%
Patients Enrolled	MA advanced GEC.
Administration Dosage	15 mg/kg IV, once every 3 weeks.
Related Clinical Trial
NCT Number	NCT01472016	Clinical Status	Phase 1
Clinical Description	A multi-center, phase 1/1b, open-label, dose escalation study of ABT-700, a monoclonal antibody in subjects with advanced solid tumors.
Primary Endpoint	Among these patients, three achieved a partial response and one had progressive disease as best response (ORR=75.00%). The duration of disease control in responders ranged from 18-27 weeks and the median duration of response was 16.10 weeks. The median progression- free survival in MET-amplified patients was 17.90 weeks.
Experiment 18 Reporting the Activity Date of This ADC					[19]
Related Clinical Trial
NCT Number	NCT01915472	Clinical Status	Phase 2
Clinical Description	A phase 2 study of IMMU 130 (hmn-14-SN38 antibody drug conjugate) in patients with metastatic colorectal cancer.
Experiment 19 Reporting the Activity Date of This ADC					[20]
Related Clinical Trial
NCT Number	NCT01001442	Clinical Status	Phase 1/2
Clinical Description	A phase 1/2a multi-dose escalation study to evaluate maximum tolerated dose (MTD), pharmacokinetics (PK), safety and efficacy of BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.
Experiment 20 Reporting the Activity Date of This ADC					[21]
Related Clinical Trial
NCT Number	NCT01270698	Clinical Status	Phase 1
Clinical Description	A phase 1 study of IMMU-130 (hmn-14-SN38 antibody drug conjugate) in patients with colorectal cancer.
Experiment 21 Reporting the Activity Date of This ADC					[22]
Related Clinical Trial
NCT Number	NCT01605318	Clinical Status	Phase 1
Clinical Description	A phase 1/2 study of once or twice weekly IMMU-130 (hMN-14-SN38, antibody-drug conjugate) in patients with colorectal cancer.
Experiment 22 Reporting the Activity Date of This ADC					[23]
Related Clinical Trial
NCT Number	NCT00723359	Clinical Status	Phase 1
Clinical Description	A phase 1 dose escalation study to evaluate maximum tolerated dose (MTD), pharmacokinetics (PK), and safety of BT062 in subjects with relapsed or relapsed/refractory multiple myeloma.
Experiment 23 Reporting the Activity Date of This ADC					[24]
Patients Enrolled	Nonsmall-cell lung cancer (NSCLC) with c-Metoverexpressing tumors (c-Met positive; immunohistochemistry membrane H-score 150).
Administration Dosage	Teliso-V was administered by intravenous (IV) infusion to groups of three to six patients who were enrolled in eight-dose cohorts for dosing at 0.15 to 3.30 mg/kg on day 1, once every 21 days, or until disease progression or unacceptable toxicity.
Related Clinical Trial
NCT Number	NCT02099058	Clinical Status	Phase 1
Clinical Description	A multicenter, phase 1/1b, open-label, dose-escalation study of ABBV-399, an antibody drug conjugate, in subjects with advanced solid tumors.
Primary Endpoint	No formal MTD was identified.

Ref 1	Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer
Ref 2	Phase 1 study of telisotuzumab vedotin in Japanese patients with advanced solid tumors
Ref 3	Results from a phase Ib study of telisotuzumab vedotin in combination with osimertinib in patients with c-Met protein-overexpressing, EGFR-mutated locally advanced/metastatic non-small-cell lung cancer (NSCLC) after progression on prior osimertinib
Ref 4	FDA Approved Drug Products: Emrelis (telisotuzumab vedotin-tllv) for intravenous injection
Ref 5	Study of Telisotuzumab Vedotin (ABBV-399) in Participants With Previously Treated c-Met+ Non-Small Cell Lung Cancer
Ref 6	A Study Evaluating the Safety, Pharmacokinetics (PK), and Preliminary Efficacy of ABBV-399 in Participants With Advanced Solid Tumors
Ref 7	A Study to Assess Disease Activity and Adverse Events of Intravenous (IV) Telisotuzumab Vedotin Compared to IV Docetaxel in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Ref 8	A Study to Assess Disease Activity of Intravenously (IV) Infused Telisotuzumab Vedotin in Adult Participants With Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Ref 9	Study of Intravenous Telisotuzumab Vedotin in Combination Osimertinib or Standard of Care Chemotherapy to Assess Change in Disease Activity in Adult Participants With Non-Small Cell Lung Cancer That Has a Mutation in the Epidermal Growth Factor Receptor Gene and That Overexpresses the c-Met Protein
Ref 10	A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Ref 11	Expanded Access to Telisotuzumab Vedotin
Ref 12	A Study to Evaluate the Safety and Pharmacokinetics ABBV-399 in Japanese Participants With Solid Tumors
Ref 13	A Study to Assess Prevalence of a Specific Protein Overexpression in Adult Participants With Non-Small Cell Lung Cancer
Ref 14	A Phase 1b Study of Telisotuzumab Vedotin in Combination With Nivolumab in Patients With NSCLC. JTO Clin Res Rep. 2021 Dec 4;3(1):100262.
Ref 15	Phase I Study of 2- or 3-Week Dosing of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, Monotherapy in Patients with Advanced Non-Small Cell Lung Carcinoma. Clin Cancer Res. 2021 Nov 1;27(21):5781-5792.
Ref 16	Phase Ib Study of Telisotuzumab Vedotin in Combination With Erlotinib in Patients With c-Met Protein-Expressing Non-Small-Cell Lung Cancer. J Clin Oncol. 2023 Feb 10;41(5):1105-1115.
Ref 17	Indatuximab ravtansine plus dexamethasone with lenalidomide or pomalidomide in relapsed or refractory multiple myeloma: a multicentre, phase 1/2a study. Lancet Haematol. 2021 Nov;8(11):e794-e807.
Ref 18	Phase I study of ABT-700, an anti-c-Met antibody, in patients (pts) with advanced gastric or esophageal cancer (GEC). Journal of Clinical Oncology 33, no. 3_suppl (January 20, 2015) 167-167.
Ref 19	A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer, NCT01915472
Ref 20	A Phase I/IIa Multi-Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), Safety and Efficacy of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma, NCT01001442
Ref 21	A Phase I Study of IMMU-130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Colorectal Cancer. NCT01270698
Ref 22	A Phase I/II Study of Once or Twice Weekly IMMU-130 (hMN-14-SN38, Antibody-Drug Conjugate) in Patients With Colorectal Cancer. NCT01605318
Ref 23	A Phase I Dose Escalation Study to Evaluate Maximum Tolerated Dose (MTD), Pharmacokinetics (PK), and Safety of BT062 in Subjects With Relapsed or Relapsed/Refractory Multiple Myeloma, NCT00723359
Ref 24	First-in-Human Phase I, Dose-Escalation and -Expansion Study of Telisotuzumab Vedotin, an Antibody-Drug Conjugate Targeting c-Met, in Patients With Advanced Solid Tumors. J Clin Oncol. 2018 Nov 20;36(33):3298-3306.