Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Carotuximab · 2 trials · 3 indications
From the start of study treatment until documented progression, per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) and Prostate Cancer Working Group 3, or death due to any cause.
The number of adverse events are graded by NCI CTCAE v5.0. The number of these dose-limiting toxicities (DLTs) experienced within the first treatment cycle (28 days) will be assessed to determine the RP2D.
| Arm | Type | Description |
|---|---|---|
| Apalutamide monotherapy | ACTIVE_COMPARATOR | After progression, subjects will crossover to combination therapy |
| Combination therapy (Apalutamide + Carotuximab) | EXPERIMENTAL | - |
| Osimertinib with Carotuximab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Apalutamide | DRUG | Standard of care Apalutamide 240 mg administered orally and daily on Days 1-28 of every 28 day cycle |
| Carotuximab | DRUG | Carotuximab administered intravenously at the following doses: Cycle 1 Day 1: 3 mg/kg Cycle 1 Day 4: 7 mg/kg Cycle 1 Day 8: 10 mg/kg Cycle 1 Day 15: 10 mg/kg Cycle 1 Day 22: 10 mg/kg Cycle 2 Day 1: 15 mg/kg Cycle 2 Day 15: 15 mg/kg Cycle 3+ Day 1: 15 mg/kg After completion of cycle 2, dosing of carotuximab will continue at a q4 week schedule using the 15 mg/kg dose. |
| Osimertinib | DRUG | Osimertinib given by mouth daily at 40mg or 80mg depending on the starting dose level assigned per investigator. Therapy will continue until disease progression, patient withdrawal, or treatment intolerance. |
Inclusion Criteria: * History of castration-resistant prostate cancer with rising PSA (prostate-specific antigen) on a contemporary ARSI (Androgen receptor (AR) signaling inhibitor: abiraterone, enzalutamide, darolutamide). Bicalutamide, nilutamide, and flutamide will not be considered as contempor...