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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05067140 | A Study of ARV-766 Given by Mouth in Men With Metastatic Prostate Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 152 | — | — | Sep 2, 2021 | May 25, 2027 | May 5, 2026 | 23 | United States |
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Evaluate PSA in patients with mCRPC in both dose groups
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), and timing.
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE v 5.0), timing, seriousness, and relationship to study drug.
Evaluate PSA in patients with NHA-naïve mPC
| Arm | Type | Description |
|---|---|---|
| ARV-766 | EXPERIMENTAL | Oral tablets, once daily in 28 day cycles |
| ARV-766 + Abiraterone | EXPERIMENTAL | Oral tablets, once daily in 28 day cycles |
| Name | Type | Description |
|---|---|---|
| ARV-766 Part A&B | DRUG | Part A: Daily oral dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part B: Oral tablet(s) once daily in 28 day cycles. |
| ARV-766 + Abiraterone Part C&D | DRUG | Part C: Daily oral combination dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment. Part D: Combination administered once daily in 28 day cycles. Parts C\&D: Participants will also receive concomitant corticosteroid and ADT therapy of investigator choice/patient preference |
Inclusion Criteria: Part A,B,C and D: * Histological, pathological, or cytological confirmed diagnosis of adenocarcinoma of the prostate. * Ongoing androgen deprivation therapy (ADT) with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration). * Easte...