Approval Probability
TA Base Rate
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ML Risk
Also known as ENV105, TRC105
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...
Carotuximab is an investigational monoclonal antibody being studied in oncology for castration-resistant prostate cancer and non small cell lung cancer. It is not yet approved for commercial use. Kairos Pharma, Ltd. is developing it in Phase 2 clinical development, with trials combining it with apalutamide in prostate cancer and osimertinib in EGFR-mutated lung cancer.
Carotuximab targets ENG, also known as endoglin. It is an inhibitor of this target. Endoglin is a cell surface receptor involved in angiogenesis, and inhibiting it is the intended mechanism of action for this monoclonal antibody in cancer treatment.
Carotuximab is being developed by Kairos Pharma, Ltd., which trades under the ticker KAPA. The company is the sponsor of the clinical trials evaluating the drug in castration-resistant prostate cancer and non small cell lung cancer.
Carotuximab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 trial is in castration-resistant prostate cancer, and a Phase 1 trial is in EGFR-mutated non small cell lung cancer.
Carotuximab is being studied in two recruiting trials. NCT05534646 is a Phase 2 study of apalutamide with carotuximab in metastatic castration-resistant prostate cancer, enrolling 100 male participants in the United States. NCT05401110 is a Phase 1 study of osimertinib with carotuximab in advanced EGFR-mutated non small cell lung cancer, enrolling 60 participants in the United States.