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ABBV-969 · 1 trial · 1 indication
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....
ABBV-969 is an investigational small molecule being developed for the treatment of metastatic castration-resistant prostate cancer. It is administered intravenously and is currently in Phase 1 clinical development. The drug is being studied in adult male participants with this condition.
ABBV-969 is being developed by AbbVie Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug in patients with metastatic castration-resistant prostate cancer.
ABBV-969 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The ongoing Phase 1 study is designed to assess adverse events and how the intravenously infused drug moves through the bodies of adult participants with metastatic castration-resistant prostate cancer.
ABBV-969 is being studied in a Phase 1 clinical trial registered as NCT06318273. This active, non-recruiting study has an enrollment of 152 participants and is being conducted in the United States, Australia, Canada, France, Israel, Japan, and Spain. The trial includes adult male participants aged 18 years and older with metastatic castration-resistant prostate cancer.
ABBV-969 is administered intravenously, meaning it is given through a vein. The Phase 1 clinical trial is evaluating how the drug moves through the body after intravenous infusion in adult participants with metastatic castration-resistant prostate cancer. The study is also assessing adverse events associated with the treatment.