General Information of This Payload
Payload ID
PAY0VRVTR
Name
A-1770637
Target DNA topoisomerase 1 (TOP1)
Structure
Each Antibody-drug Conjugate Related to This Payload
Full Information of The Activity Data of The ADC(s) Related to This Payload
Turmetabart adizutecan [Phase 3]
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 Objective Response Rate (ORR)
21%
Patients Enrolled
Eligible participants have ECOG 0-1, adequate organ function, QTc ≤450/470 msec (M/F), and measurable disease (RECIST 1.1/RANO). Parts 1-4 include R/R SCLC/CNS tumors/NECs progressing after SOC. Exclusions: ILD/pneumonitis, prior Top1-ADC therapy, or (Part 2) prior SEZ6-ADC. Fresh/archival tumor tissue is required for SEZ6 analysis.
Administration Dosage
ABBV-706 was administered IV at 1.3-3.5 mg/kg doses Q3W in 21-d cycles.
Related Clinical Trial
NCT Number NCT05599984  Phase Status PHASE1
Clinical Description
A Phase 1 First-in-Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-706 as Monotherapy and in Combination With Budigalimab (ABBV-181), Carboplatin, or Cisplatin in Adult Subjects With Advanced Solid Tumors
Primary Endpoint
Primary outcomes include AE incidence, PK parameters (Cmax, Tmax, t½, AUC), immunogenicity (ADA/nAb incidence), and tumor response metrics (ORR per RECIST 1.1/RANO, DOR, PFS, OS) assessed over ~2 years. The RP2D will be determined based on safety, PK, and efficacy data.
ABBV-969 [Phase 1]
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 [2]
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  Phase 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 Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors
Ref 2 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