Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apalutamide · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Apalutamide monotherapy | ACTIVE_COMPARATOR | After progression, subjects will crossover to combination therapy |
| Combination therapy (Apalutamide + 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. |
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...
Apalutamide is used for castration-resistant prostate cancer, specifically in a Phase 2 study for metastatic, castration-resistant prostate cancer. It is an investigational small molecule being studied in combination with carotuximab in this patient population.
Apalutamide is an androgen receptor inhibitor. It works by blocking the androgen receptor, which is involved in the growth of prostate cancer cells. This mechanism is being studied in the context of metastatic, castration-resistant prostate cancer.
Apalutamide is being developed by Kairos Pharma, Ltd., a company traded under the ticker KAPA. The company is conducting a Phase 2 clinical trial of apalutamide in combination with carotuximab for metastatic, castration-resistant prostate cancer.
Apalutamide is in Phase 2 clinical development. It is currently being studied in a Phase 2 trial for metastatic, castration-resistant prostate cancer. The drug is investigational and has not been approved by regulatory authorities for this use.
Apalutamide is being studied in a Phase 2 clinical trial with the identifier NCT05534646. The trial is titled 'Study of Apalutamide With Carotuximab in Metastatic, Castration-Resistant Prostate Cancer' and is currently recruiting participants in the United States.
Apalutamide is also known by the brand name Erleada. In the context of this development program, Kairos Pharma is studying apalutamide in combination with carotuximab for metastatic, castration-resistant prostate cancer.