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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05011188 | FOR46 in Combination With Enzalutamide in Patients With Metastatic Castration Resistant Prostate Cancer | PHASE1 | ACTIVE NOT_RECRUITING | 44 | — | — | Jan 19, 2022 | Jul 31, 2027 | Aug 27, 2025 | 1 | United States |
A minimum of 3 patients will be treated at each dose level. If \< 33%of patients (i.e. 0 of 3 patients, or 1 of 6 patients) within a cohort have a dose-limiting toxicity (DLT in Cycle 1, then enrollment of the next cohort may commence upon approval of Data and Safety Monitoring Committee. At any dose level, dose escalation will be discontinued if \>= 2 of 3 to 6 patients within a cohort experience a DLT in Cycle 1, the MTD will have been exceeded. The previous dose level will then be considered the MTD if 6 patients were previously evaluated at this dose level. If this dose level was previously evaluated with 3 patients, then 3 additional patients will be enrolled at this dose level; if 0 or 1 of the additional 3 patients experiences a DLT in Cycle 1, then this dose level will be considered the MTD.
Dose-limiting toxicities classified using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0will be tabulated by dose level and reported in descriptive fashion.
Composite response is defined as a \>= 50% decline from baseline PSA (defined by Cycle 1 Day 1 value), confirmed by repeat measurement \>= 4 weeks later AND/OR objective tumor response by RECIST 1.1 criteria The composite response rate along with 95% confidence interval will be reported
| Arm | Type | Description |
|---|---|---|
| Does Escalation | EXPERIMENTAL | Approximately 3 dose levels of FOR46 will be evaluated. Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) 6mg, subcutaneously (SQ) will also be administered on Day 2 during all treatment cycles. Pegfilgrastim could be modified to a lower dose of 3 mg with treating investigator approval. |
| Dose Expansion | EXPERIMENTAL | Participants will receive a lead-in treatment period of enzalutamide monotherapy for 14 days (day -14 to day -1), followed by addition of FOR46 on Cycle 1 Day 1, at the maximum tolerated dose (MTD) as determined in Phase 1b. If participants are on enzalutamide at the time of study entry, and remain on continuous dosing at 160 mg daily, the lead-in treatment period will not be required. Prophylactic Pegfilgrastim (G-CSF) 6mg, subcutaneously (SQ) will also be administered on Day 2 during all treatment cycles. Pegfilgrastim could be modified to a lower dose of 3 mg with treating investigator approval. |
| Name | Type | Description |
|---|---|---|
| FOR46 | BIOLOGICAL | Given intravenously (IV) |
| Enzalutamide | BIOLOGICAL | Given orally (PO) |
| Pegfilgrastim | DRUG | Given subcutaneously (subQ) |
| Blood Samples | PROCEDURE | Blood samples will be taken for correlative studies |
Inclusion Criteria: 1. Histologically confirmed metastatic prostate adenocarcinoma. 2. Disease progression by PCWG3 criteria at study entry. 3. Prior progression by PCWG3 criteria on one or more androgen signaling inhibitors including abiraterone acetate, enzalutamide, apalutamide, and/or darolutam...