Antibody-drug Conjugate Information

General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0COMTY
ADC Name
Telisotuzumab vedotin
Synonyms
ABBV-399; ABT 399; ABT-399; Teliso-V; ABBV399; ABBV 399
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Organization
AbbVie, Inc.; BSP Pharmaceuticals SpA
Drug Status
Phase 3
Indication
In total 4 Indication(s)
Non-small cell lung cancer [ICD11:2C25]
Phase 3
MET(+) non-small cell lung cancer [ICD11:2C25]
Phase 1
Solid tumors [ICD11:2A00-2A0Z|2B50-2F9Z]
Phase 1
Squamous cell cancer [ICD11:2D60-2D61]
Terminated in phase 2
Drug-to-Antibody Ratio
3.1
Structure
Antibody Name
Telisotuzumab
  Antibody Info 
Antigen Name
Hepatocyte growth factor receptor (MET)
  Antigen Info 
Payload Name
Monomethyl auristatin E
  Payload Info 
Therapeutic Target
Microtubule (MT)
  Target Info 
Linker Name
Mc-Val-Cit-PABC
  Linker Info 
Conjugate Type
Random conjugation through reduced inter-chain cysteines.
Combination Type
Vedotin
Special Approval(s)
Breakthrough therapy(FDA)
Puchem SID
381127969 , 472406559 , 374364150 , 384585322 , 404772545
Drugbank ID
DB15104
DrugMap ID
DM8UCNK
TTD ID
D42TUS
ChEBI ID
CHEMBL3990032
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 12 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
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.

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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.
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  NCT01270698
Phase 1
A phase 1 study of 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.
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 12 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
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.

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Experiment 2 Reporting the Activity Date of This ADC [2]
Efficacy Data Objective Response Rate (ORR)
23.00% (all)
28.00% (in once every 2 weeks cohorts
all)
18.00% (in once every 3 weeks cohorts)
18.00% (nonsquamous NSCLC)
31.00% (in once every 2 weeks cohorts
nonsquamous NSCLC)
6.00% (in once every 3 weeks cohorts
nonsquamous NSCLC)
43.00% (squamous NSCLC)
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 3 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR)
30.55% (for all efficacy-evaluable patients)
32.10% (for EGFR-M+ patients)
52.60% (of EGFR-M+ patients, those who were c-Met high)
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+.

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Experiment 4 Reporting the Activity Date of This ADC [3]
Efficacy Data Objective Response Rate (ORR)
30.60% (for all efficacy-evaluable patients)
32.18% (for EGFR-M+ patients)
52.60% (of EGFR-M+ patients, those who were c-Met high)
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 5 Reporting the Activity Date of This ADC [4]
Efficacy Data Objective Response Rate (ORR)
71.70% (plus lenalidomide)
70.60% (plus pomalidomide)
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 6 Reporting the Activity Date of This ADC [5]
Efficacy Data Objective Response Rate (ORR)
75.00%
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 7 Reporting the Activity Date of This ADC [6]
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 8 Reporting the Activity Date of This ADC [7]
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 9 Reporting the Activity Date of This ADC [8]
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.
Experiment 10 Reporting the Activity Date of This ADC [9]
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 11 Reporting the Activity Date of This ADC [10]
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 12 Reporting the Activity Date of This ADC [11]
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.
References
Ref 1 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 2 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 3 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 4 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 5 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 6 A Phase II Study of IMMU 130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Metastatic Colorectal Cancer, NCT01915472
Ref 7 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 8 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.
Ref 9 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 10 A Phase I Study of IMMU-130 (hMN-14-SN38 Antibody Drug Conjugate) in Patients With Colorectal Cancer. NCT01270698
Ref 11 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

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