Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
COM701 · 3 trials · 14 indications
Progression free survival in COM701-treated participants compared to placebo-treated participants
The proportion of subjects with any adverse event (AE) per CTCAE v5.0.
The proportion of subjects with adverse events meeting the criteria of dose-limiting toxicities (DLTs) in the 1st 28 days of the 1st cycle of study treatment during dose escalation.
The dose of COM701 in combination with BMS-986207 and nivolumab for the expansion cohort.
The PK profile of COM701 in combination with BMS-986207 and nivolumab.
To evaluate the safety profile of COM701 monotherapy and in combination with nivolumab.
| Arm | Type | Description |
|---|---|---|
| COM701 | EXPERIMENTAL | - |
| Normal Saline | PLACEBO_COMPARATOR | - |
| Dose Escalation Cohorts. | EXPERIMENTAL | Up to 5 sequential dose escalation cohorts of COM701 in combination with fixed doses of BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks until a maximum tolerated dose or recommended dose for expansion is identified. |
| Cohort 1 Expansion Cohort A (ovarian cancer) | EXPERIMENTAL | Single arm: subjects with platinum resistant/refractory epithelial ovarian cancer, primary peritoneal or fallopian tube cancer will be randomized to receive study treatment with COM701 in combination with BMS-986207 and nivolumab. The study drugs will be administered IV every 4 weeks. |
| Cohort 2 Expansion Cohort (endometrial cancer). | EXPERIMENTAL | Single arm: subjects with MSS-endometrial cancer will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks. |
| Cohort 3 Expansion Cohort (basket cohort - high PVRL2 tumors). | EXPERIMENTAL | Single arm: subjects with tumor types with high expression of PVRL2 will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks. |
| Cohort 4 Expansion Cohort (Head and Neck cancer). | EXPERIMENTAL | Two arms: subjects with head and neck cancer. Equal number of subjects in each of the 2 arms. One arm will enroll subjects who have not previously received treatment with an immune checkpoint inhibitor, the other arm will enroll subjects who have received prior treatment with an immune checkpoint inhibitor. All subjects will receive study treatment with COM701 in combination with BMS-986207 and nivolumab. All study drugs will be administered IV every 4 weeks. |
| P1a Arm A (Monotherapy Dose Escalation). | EXPERIMENTAL | COM701 monotherapy sequential dose escalation administered IV every 3 weeks and a Cohort IV every 4 weeks. Up to 8 dose escalation cohorts may be evaluated until a maximum tolerated dose or recommended phase 2 dose is identified. |
| P1a Arm B (Combination Dose Escalation). | EXPERIMENTAL | COM701 sequential dose escalation administered IV every 3 weeks in combination with Opdivo (Nivolumab) 360mg administered IV every 3 weeks and COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480mg administered IV every 4 weeks. |
| P1a Arm A (Monotherapy Expansion). | EXPERIMENTAL | COM701 monotherapy administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (NSCLC, Breast, Ovarian, Endometrial and Colorectal cancer). |
| P1b (Combination Cohort Dose Expansion). | EXPERIMENTAL | COM701 administered IV every 4 weeks in combination with Opdivo (Nivolumab) 480 mg administered IV every 4 weeks. Cohort expansion in subjects with the following select tumor types (Breast, Ovarian, Endometrial and Colorectal cancer). |
| Name | Type | Description |
|---|---|---|
| COM701 | DRUG | COM701 will be administered via intravenous (IV) infusion once every 3 weeks. |
| Normal Saline | DRUG | Saline will be administered via intravenous (IV) infusion once every 3 weeks |
| COM701 in combination with BMS-986207 and nivolumab. | DRUG | Study treatment with the 3 drug combination (COM701 in combination with BMS-986207 and nivolumab). |
| COM701 with Opdivo (Nivolumab). | DRUG | COM701 in combination with Opdivo (Nivolumab). |
Inclusion Criteria: * Has relapsed platinum sensitive epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer * Has completed at least 2 previous courses (i.e. lines) of platinum-containing therapy * For the last chemotherapy course prior to being randomized into the study, mu...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
COM701 is an investigational small molecule cancer therapy developed by Compugen Ltd. (ticker CGEN). It is being studied in Phase 1 clinical trials for advanced solid tumors, including ovarian cancer, endometrial neoplasms, and other advanced cancers. COM701 is designed as an inhibitor of PVRIG, a protein target involved in immune regulation.
COM701 targets PVRIG, a protein that functions as an immune checkpoint. By inhibiting PVRIG, COM701 is designed to modulate immune responses against tumor cells. PVRIG belongs to the protein class of molecular targets. This mechanism is being evaluated in Phase 1 studies of advanced solid tumors.
COM701 is developed by Compugen Ltd., a biopharmaceutical company traded under the ticker CGEN. Compugen is responsible for the clinical development of COM701, including its Phase 1 trials in advanced cancers and its combination studies with other agents such as BMS-986207 and nivolumab.
COM701 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program includes studies in advanced solid tumors, ovarian cancer, and endometrial neoplasms, with a completed trial in combination with BMS-986207 and nivolumab and an active trial in relapsed platinum sensitive ovarian cancer.
COM701 has been studied in Phase 1 trials including NCT03667716 in advanced solid tumors, NCT04570839 in combination with BMS-986207 and nivolumab in advanced solid tumors, and NCT06888921 in relapsed platinum sensitive ovarian cancer. The ovarian cancer trial is active but not recruiting, while the other two are completed.