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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03888612 | Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer | PHASE1 | COMPLETED | 248 | — | — | Mar 1, 2019 | Jan 27, 2025 | Apr 1, 2025 | 54 | United States |
First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
PSA response rate per PCWG3.
Overall RECIST response rate in patients with measurable disease at baseline.
To evaluate the clinical anti-tumor activity (PSA response rate per PCWG3, Overall RECIST RR, rPFS, and PFS) of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy.
| Arm | Type | Description |
|---|---|---|
| ARV-110 | EXPERIMENTAL | Part A: Oral tablet(s), once or twice daily in 28 day cycles Part B: Oral tablet(s), once or twice daily in 28 day cycles |
| Name | Type | Description |
|---|---|---|
| ARV-110 | DRUG | Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A |
Inclusion Criteria: Part A: * Patients must be male and at least 18 years of age at the time of signing the informed consent. * Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate. *...