Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as TSR-022
Cobolimab · 3 trials · 14 indications
OS is defined as the time from the date of randomization to the date of death due to any cause.
OS is defined as the time from the date of randomization to the date of death due to any cause.
Confirmed ORR is defined as the proportion of participants who have achieved confirmed complete response (CR) or confirmed partial response (PR), evaluated using disease-specific tumor assessment criteria based on Investigator assessment
| Arm | Type | Description |
|---|---|---|
| Participants receiving cobolimab+ dostarlimab+ docetaxel | EXPERIMENTAL | - |
| Participants receiving dostarlimab+ docetaxel | EXPERIMENTAL | - |
| Participants receiving docetaxel | ACTIVE_COMPARATOR | - |
| Part 1- Dose determination | EXPERIMENTAL | - |
| Part 2- Dose expansion | EXPERIMENTAL | - |
| Part 1a: TSR-022 monotherapy | EXPERIMENTAL | - |
| Part 1b: TSR-022 in combination with nivolumab | EXPERIMENTAL | - |
| Part 1c: TSR-022 in combination with TSR-042 | EXPERIMENTAL | - |
| Part 1d: TSR-022 in combination with TSR-042 and TSR-033 | EXPERIMENTAL | - |
| Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1) | EXPERIMENTAL | - |
| Part 1f: TSR-022 in combination with TSR-042 and Docetaxel | EXPERIMENTAL | - |
| Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin | EXPERIMENTAL | - |
| Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin | EXPERIMENTAL | - |
| Part 2: Cohort A Melanoma-TSR-022 as monotherapy | EXPERIMENTAL | - |
| Part 2: Cohort A Melanoma-TSR-022 with TSR-042 | EXPERIMENTAL | - |
| Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy | EXPERIMENTAL | - |
| Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 | EXPERIMENTAL | - |
| Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy | EXPERIMENTAL | - |
| Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042 | EXPERIMENTAL | - |
| Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042 | EXPERIMENTAL | - |
| Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel | EXPERIMENTAL | - |
| Part 2: Cohort F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Cobolimab | BIOLOGICAL | Cobolimab will be administered. |
| Dostarlimab | BIOLOGICAL | Dostarlimab will be administered. |
| Docetaxel | DRUG | Docetaxel will be administered. |
| TSR-022 | DRUG | TSR-022 will be administered. |
| Nivolumab | DRUG | Nivolumab will be administered. |
| TSR-042 | DRUG | TSR-042 will be administered. |
| TSR-033 | DRUG | TSR-033 will be administered. |
| Pemetrexed | DRUG | Pemetrexed will be administered. |
| Cisplatin | DRUG | Cisplatin will be administered. |
| Carboplatin | DRUG | Carboplatin will be administered. |
Inclusion Criteria: * Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma. * Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (...
Cobolimab is an investigational monoclonal antibody being studied in oncology for advanced solid tumors. Its clinical development covers non-small cell lung cancer that has progressed on prior anti-PD-(L)1 therapy and chemotherapy, melanoma, and other neoplasms. It is also being evaluated in pediatric and young adult patients with cancers including melanoma, Hodgkin lymphoma, gliomas, and osteosarcoma.
Cobolimab targets HAVCR2, also known as TIM-3, and acts as an inhibitor of this target. By binding HAVCR2, the monoclonal antibody is designed to interfere with a checkpoint pathway that can suppress immune responses against tumors. This mechanism places Cobolimab in the immunotherapy class of oncology agents.
Cobolimab is being developed by GSK plc, which trades under the ticker GSK. The company is the sponsor of the clinical program evaluating the drug in oncology indications, including non-small cell lung cancer and melanoma.
Cobolimab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 2 program includes a randomized, active-controlled study in advanced non-small cell lung cancer, and additional Phase 1 studies are ongoing in other tumor types.
Cobolimab is being studied in three registered trials. NCT04655976 is a Phase 2 study in advanced non-small cell lung cancer comparing Cobolimab plus dostarlimab plus docetaxel against dostarlimab plus docetaxel and docetaxel alone. NCT06521567 is a Phase 1 study in pediatric and young adult cancer patients, and NCT02817633 is a Phase 1 study in advanced solid tumors.
Yes, Cobolimab is also known as TSR-022. TSR-022 was the earlier designation used for the same monoclonal antibody, and the AMBER Phase 1 study in advanced solid tumors was conducted under that name. Both names refer to the same investigational HAVCR2 inhibitor developed by GSK.