Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06318273 | 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 | PHASE1 | RECRUITING | 230 | — | — | Mar 8, 2024 | May 1, 2027 | Apr 8, 2026 | 26 | United States, Australia +5 |
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
PSA response is defined as \>= 50% PSA decrease from baseline.
| Arm | Type | Description |
|---|---|---|
| Part 1: ABBV-969 Monotherapy Dose Escalation | EXPERIMENTAL | Participants with metastatic castration-resistant prostate cancer (mCRPC) will receive ABBV-969 monotherapy once every 21 days |
| Part 2 A: Monotherapy Dose Expansion/Dose Optimization | EXPERIMENTAL | Participants with mCRPC will receive dose A of ABBV-969 (dose levels determined in Part 1) for dose optimization. |
| Part 2 B: Monotherapy Dose Expansion/Dose Optimization | EXPERIMENTAL | Participants with mCRPC will receive Dose B of ABBV-969 (dose levels determined in Part 1) for dose optimization. |
| Name | Type | Description |
|---|---|---|
| ABBV-969 | DRUG | Intravenous (IV) Infusion |
Inclusion Criteria: * Histological, pathological, and/or cytological confirmation of adenocarcinoma of the prostate. * Estimated life expectancy \> 6 months. * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Must have progressed on prior novel hormonal agents (NHAs) (e....