Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0CCEQO
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| ADC Name |
telisotuzumab adizutecan
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| Synonyms |
telisotuzumab adizutecan; ABBV-400; Temab-A
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| Organization |
AbbVie (Top20 MNC) (Originator)
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| Drug Status |
Phase 3
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| Structure |
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| Antibody Name |
Telisotuzumab
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Antibody Info | ||||
| Antigen Name |
Hepatocyte growth factor receptor (MET); Macrophage-stimulating protein receptor (MST1R)
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Antigen Info | ||||
| Payload Name |
AMDCPT
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Adizutecan linker
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Linker Info | ||||
| Conjugate Type |
Undisclosed
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| Combination Type |
adizutecan
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | ||||||||
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| Biliary tract cancer |
1 Trials
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| Breast cancer |
1 Trials
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| Colorectal cancer |
1 Trials
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1 Trials
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1 Trials
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1 Trials
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| Gastroesophageal junction adenocarcinoma |
1 Trials
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| Head and neck cancer |
2 Trials
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| Kidney cancer |
1 Trials
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| Liver cancer |
1 Trials
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| Lung cancer |
1 Trials
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1 Trials
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| Oesophageal cancer |
1 Trials
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| Ovarian cancer |
1 Trials
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| Pancreatic cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Efficacy Data | Objective Response Rate (ORR) |
18%
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| Patients Enrolled |
Eligibility varies by study part but generally requires advanced solid tumors (NSCLC, GEA, CRC, or MET-altered tumors) with progression on standard therapies, ECOG PS 0-1, and adequate organ function. Key exclusions include ILD/pneumonitis history, active lung diseases, and prior TAS-102/regorafenib treatment for Part 7 CRC participants.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT05029882 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 as Monotherapy and in Combination With Bevacizumab in Adult Subjects With Advanced Solid Tumors | ||||
| Primary Endpoint |
The primary efficacy endpoint is Objective Response Rate (ORR) evaluated by the investigator per RECIST v1.1 over 24 months, defined as the proportion of participants achieving confirmed complete response (CR) or partial response (PR).
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| Other Endpoint |
Secondary endpoints include Duration of Response (DOR) for participants with confirmed CR/PR, Progression-Free Survival (PFS), and Overall Survival (OS), all assessed per RECIST v1.1 criteria by investigator review over a 24-month period.
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants must have measurable disease of specified tumor types (HCC, PDAC, HNSCC etc.) and meet protocol-defined lab criteria. Key exclusions include prior anticancer therapy within 28 days, active ILD/pneumonitis, untreated CNS metastases, concurrent autoimmune disorders with pulmonary involvement, and unresolved Grade >1 toxicities from prior treatments.
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| Administration Dosage |
.
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| Related Clinical Trial | |||||
| NCT Number | NCT06084481 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Open-Label Study to Evaluate the Efficacy and Safety of ABBV-400 in Select Advanced Solid Tumor Indications | ||||
| Primary Endpoint |
The primary efficacy endpoint is Objective Response Rate (ORR) assessed over 24 months, defined as the proportion of participants achieving confirmed PR or better per RECIST 1.1 criteria.
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| Other Endpoint |
Secondary objectives include evaluating Duration of Response (DOR), Clinical Benefit Rate (CBR), Progression-Free Survival (PFS), and Overall Survival (OS). Pharmacokinetic parameters (Cmax, Tmax, AUC) of ABBV-400, total ADC concentration, Top1 inhibitor payload levels, and immunogenicity (ADA/nADA) will be assessed throughout 24 months.
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible participants must have histologically confirmed unresectable mCRC with measurable disease, having progressed on only one first-line systemic metastatic treatment. Exclusion criteria include BRAF V600E mutation, dMMR+/MSI-H status, and recent anticancer therapies within 28 days or 5 half-lives prior to study initiation.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06107413 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2, Randomized Study to Evaluate Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Folinic Acid, and Bevacizumab in Previously Treated Subjects With Unresectable Metastatic Colorectal Cancer | ||||
| Primary Endpoint |
The study will evaluate Objective Response (OR) rate within 24 weeks per RECIST 1.1, Progression-Free Survival (PFS) up to 11 months, and monitor Adverse Events (AEs) for up to 3 years to assess safety and efficacy.
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| Other Endpoint |
Additional endpoints include Duration of Response (DOR) up to 7 months, Overall Survival (OS) up to 3 years, and Best Overall Response (BOR) achievement within 18 weeks, all assessed according to RECIST v1.1 criteria.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible participants must have ECOG PS 0-1, confirmed advanced/metastatic mCRC without BRAF V600E or dMMR+/MSI-H status, and measurable disease. Stage 2 requires c-Met protein expression (3+ intensity, ≥10% tumor cells). Key exclusions include recent cardiac events, prior c-Met antibody/ADC therapy, ILD/pneumonitis history, unresolved toxicities (Grade >1), untreated CNS metastases, or concurrent autoimmune/inflammatory lung disorders.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06464692 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Phase 1b Study to Evaluate Safety and Pharmacokinetics (PK) of ABBV-400 in Chinese Subjects With Unresectable Locally Advanced/Metastatic Colorectal Cancer | ||||
| Primary Endpoint |
The study will assess Dose-Limiting Toxicities (DLTs), pharmacokinetic parameters (Cmax, Tmax, AUC), total antibody levels, and unconjugated payload of Telisotuzumab Adizutecan over 24 months, with DLTs defined as severe hematologic toxicities or pneumonitis conditions unresponsive to treatment.
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| Other Endpoint |
Efficacy endpoints include Objective Response (OR) rate, Duration of Response (DoR), Best Overall Response (BOR), Progression-Free Survival (PFS), and Overall Survival (OS), all evaluated per RECIST v1.1 over a 24-month period.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible participants must have ECOG PS 0-1, ≥12 weeks life expectancy, RECIST-measurable disease. Key exclusions include prior c-MET antibody/ADC therapy, hypersensitivity to bevacizumab/trifluridine-tipiracil, and active infections per protocol.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06614192 | Clinical Status | PHASE3 | ||
| Clinical Description | AndroMETa-CRC-064: An Open Label, Randomized, Controlled, Global Phase 3 Study Comparing ABBV-400 Monotherapy to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With c-Met Over-Expressed Refractory Metastatic Colorectal Cancer | ||||
| Primary Endpoint |
The study evaluates safety (AEs, vital signs, ECGs, lab abnormalities), pharmacokinetics (Cmax, Tmax, AUC, t1/2, ADC, unconjugated Top1 inhibitor), immunogenicity (ADAs/nADAs) and efficacy (OR, PFS, OS, DOR, DC) of ABBV-400 in Stage 1, with Stage 2 focusing on efficacy and patient-reported physical function/diarrhea/QoL via EORTC QLQ-C30 over 4 years.
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| Other Endpoint |
Efficacy is assessed by BICR and investigators per RECIST v1.1, including OR, PFS, DOR, DC (CR/PR/SD), and OS in both stages. PK parameters cover total antibody, payload, ADAs. Stage 2 tracks changes in physical function, diarrhea and GHS/QoL between ABBV-400 and SOC arms.
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| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Eligible participants must have metastatic HER2-negative gastric/GEJ/esophageal adenocarcinoma, measurable disease (RECIST 1.1), ECOG PS 0-1, and known PD-L1 status. Key exclusions are prior systemic therapy for metastatic disease and significant pre-existing lung conditions as per protocol specifications.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06628310 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2 Randomized Study to Evaluate the Safety, Efficacy, and Optimal Dose of ABBV-400 in Combination With Fluorouracil, Leucovorin, and Budigalimab as First-Line Treatment in Subjects With Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (AndroMETa-GEA-977) | ||||
| Primary Endpoint |
The primary endpoints include investigator-assessed Progression-Free Survival (PFS) from first treatment dose to radiographic progression or death per RECIST 1.1, and Objective Response Rate (ORR) of confirmed complete/partial responses, evaluated over approximately 6 years.
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| Other Endpoint |
Secondary efficacy measures involve Disease Control Rate (DCR - CR/PR/SD lasting ≥16 weeks), Duration of Response (DOR), and Overall Survival (OS) from treatment initiation, all assessed per RECIST 1.1 by investigators during the 6-year study period.
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| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Eligibility requires histologically confirmed advanced/metastatic non-squamous NSCLC (Part 1: ≤1 prior systemic therapy; Part 2: treatment-naive with no actionable mutations), measurable disease per RECIST v1.1, documented PD-L1 status, and adequate organ function, excluding those with uncontrolled CNS metastases or active ILD/pneumonitis requiring steroids.
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| Administration Dosage |
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| Related Clinical Trial | |||||
| NCT Number | NCT06772623 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | An Open-label Multi-Cohort Phase 1b/2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With Budigalimab in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations | ||||
| Primary Endpoint |
Part 1 evaluates Dose-Limiting Toxicities (DLTs) of Telisotuzumab Adizutecan within 84 days, while Part 2's primary focus is Objective Response (OR) per blinded independent central review (BICR) using RECIST v1.1 over 33 months, along with monitoring adverse events (AEs) throughout the study period.
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| Other Endpoint |
Secondary endpoints for Part 2 include BICR-assessed Progression-Free Survival (PFS), Duration of Response (DOR), and Disease Control (DC) for at least 12 weeks, with additional investigator-assessed efficacy measures and PD-L1 subgroup analyses spanning OR, PFS, OS, DOR, and DC, all evaluated over 33 months.
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| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05982873 | Clinical Status | N.A. | ||
| Clinical Description | Expanded Access to ABBV-400 | ||||
References