General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0FXANL
ADC Name
ABBV-637
Synonyms
ABBV-637
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Organization
AbbVie (Top20 MNC) (Originator)
Drug Status
Phase 1
Antibody Name
Anti-EGFR antibody
 Antibody Info 
Antigen Name
Epidermal growth factor receptor (EGFR)
 Antigen Info 
Payload Name
BCL-xL inhibitor
 Payload Info 
Therapeutic Target
Bcl-2-like protein 1 (BCL2L1)
 Target Info 
Linker Name
Undisclosed
Conjugate Type
Undisclosed
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
Lung cancer
1 Trials
Trial ID
TWCT00004139; NCT04721015; jRCT2031210468; EudraCT2020-004953-57
General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Standard Type NCT Number Clinical Status Clinical Trial Description
Disease control rate (DCR)  NCT04721015
PHASE1
A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
Click To Hide/Show 1 Activity Data Related to This Level
Experiment 1 Reporting the Activity Date of This ADC [1]
Efficacy Data Disease control rate (DCR)
65
73 %
Patients Enrolled
Key eligibility: Adults with solid tumors (Part 1) or EGFR-altered NSCLC (Parts 2-3), measurable disease (RECIST 1.1), ECOG 0-1. Exclusions: cardiac dysfunction (NYHA ≥2 within 6 months), unresolved Grade 2+ toxicities, or (for Part 3) history of ILD/pneumonitis requiring steroids. Requires progression after prior therapies (platinum-based for Part 2, osimertinib for Part 3).

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Administration Dosage
Participants will receive escalating doses of ABBV-637 in 28-day cycles.
Related Clinical Trial
NCT Number NCT04721015  Clinical Status PHASE1
Clinical Description A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors
Primary Endpoint
Primary objectives evaluate safety through AE/SAE incidence (up to 3 years) and efficacy via ORR (confirmed CR/PR per RECIST 1.1 by investigator assessment) in Parts 2 and 3.
Other Endpoint
Secondary endpoints assess ORR in Part 1 (3 years), DOR (time from CR/PR to progression/death) for ABBV-637 monotherapy (12 months) and combination therapies (20 months), PFS (time to progression/death) and OS (time to death) for docetaxel/osimertinib combinations (20 months).
References
Ref 1 Study of Intravenous (IV) ABBV-637 Alone or in Combination With IV Docetaxel/Osimertinib to Assess Adverse Events and Change in Disease Activity in Adult Participants With Relapsed/Refractory (R/R) Solid Tumors