General Information of This Antibody-drug Conjugate (ADC)
ADC ID
DRG0RMHHV
ADC Name
ABBV-969
Synonyms
ABBV-969
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Organization
AbbVie (Top20 MNC) (Originator)
Drug Status
Phase 1
Drug-to-Antibody Ratio
2
Structure
Antibody Name
Anti-PSMA/STEAP1 IgG1 mAb
 Antibody Info 
Antigen Name
Glutamate carboxypeptidase 2 (FOLH1); Metalloreductase STEAP1 (STEAP1)
 Antigen Info 
Payload Name
A-1770637
 Payload Info 
Therapeutic Target
DNA topoisomerase 1 (TOP1)
 Target Info 
Linker Name
BrAc-Val-Ala
 Linker Info 
Conjugate Type
Reactive Cysteines
Combination Type
HY-148820
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
Prostate cancer
1 Trials
Trial ID
NCT06318273; jRCT2051240092; EudraCT2024-516772-15; EUCT2024-516772-15-00
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
Undisclosed  NCT06318273
PHASE1
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
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]
Patients Enrolled
Eligible participants must have mCRPC with progression post-NHAs (abiraterone/enzalutamide) and prior taxane therapy, serum testosterone ≤50 ng/dL, measurable disease (RECIST 1.1/PCWG3), PSA ≥1 ng/mL, available tumor tissue, QTc ≤470 msec, and life expectancy >6 months.
Administration Dosage
Participants will receive escalating doses of ABBV-969.
Related Clinical Trial
NCT Number NCT06318273  Clinical Status PHASE1
Clinical Description A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-969 in Adult Subjects With Metastatic Castration-Resistant Prostate Cancer
Primary Endpoint
The study evaluates safety through AE/SAE monitoring (up to 3 years) and efficacy via PSA response (≥50% decrease) in prostate cancer patients, with all events assessed by investigators for treatment relationship.
Other Endpoint
Secondary endpoints include PK analysis of ABBV-969, and RP2D determination during dose-escalation (up to 2 years) based on safety/PK data.
References
Ref 1 A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer