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Also known as Domvanalimab (DOM)
Domvanalimab · 2 trials · 2 indications
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) as measured by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using investigator assessments.
PFS is defined as the time from the date of randomization until the first date of documented progressive disease (PD) or death from any cause, whichever occurs first, as measured by RECIST v1.1 using investigator assessments.
| Arm | Type | Description |
|---|---|---|
| Treatment Group A: Domvanalimab (DOM) + Zimberelimab (ZIM) + Platinum-based Chemotherapy | EXPERIMENTAL | Participants will receive DOM + ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). |
| Treatment Group B: Zimberelimab (ZIM) + Platinum-based Chemotherapy | EXPERIMENTAL | Participants will receive ZIM + platinum-based chemotherapy (paclitaxel + carboplatin). |
| A1: Domvanalimab + Zimberelimab | EXPERIMENTAL | Domvanalimab and Zimberelimab, both administered by IV infusion |
| A2: Domvanalimab + Zimberelimab | EXPERIMENTAL | Domvanalimab and Zimberelimab, both administered by IV infusion |
| A3: Quemliclustat + Zimberelimab | EXPERIMENTAL | Quemliclustat and Zimberelimab, both administered by IV infusion |
| B1: Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy | EXPERIMENTAL | Quemliclustat, zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
| B2: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy | EXPERIMENTAL | Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
| B3: Domvanalimab + Quemliclustat + Zimberelimab + Platinum Doublet Chemotherapy | EXPERIMENTAL | Domvanalimab, Quemliclustat, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
| B4: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy | EXPERIMENTAL | Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
| B5: Domvanalimab + Zimberelimab + Platinum Doublet Chemotherapy | EXPERIMENTAL | Domvanalimab, Zimberelimab, and platinum doublet chemotherapy, all administered by IV infusion |
| C1: Quemliclustat + Zimberelimab + Docetaxel | EXPERIMENTAL | Quemliclustat, Zimberelimab, and Docetaxel, all administered by IV infusion |
| C2: Domvanalimab + Zimberelimab + Docetaxel | EXPERIMENTAL | Domvanalimab, Zimberelimab, and Docetaxel, all administered by IV infusion |
| Name | Type | Description |
|---|---|---|
| Domvanalimab | DRUG | Administered intravenously |
| Zimberelimab | DRUG | Administered intravenously |
| Paclitaxel | DRUG | Administered intravenously |
| Carboplatin | DRUG | Administered intravenously |
| Quemliclustat | DRUG | Administered as specified in the treatment arm |
| Docetaxel | DRUG | Administered as specified in the treatment arm |
| Platinum-Based Doublet | DRUG | Administered as specified in the treatment arm |
Key Inclusion Criteria: * Histologically or cytologically confirmed r/m squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx that is considered incurable by local therapies. * No prior systemic therapy for r/m HNSCC. Individuals who had disease progression or recurrence m...
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Domvanalimab is an investigational monoclonal antibody being studied in oncology for advanced non-small cell lung cancer and head and neck squamous cell carcinoma. It is being developed by Gilead Sciences, Inc. as part of combination immunotherapy treatment regimens. It is not yet approved for any indication and remains in clinical development.
Domvanalimab targets TIGIT, an immune checkpoint receptor. It is classified as a TIGIT inhibitor. By binding TIGIT, the antibody is designed to interfere with a checkpoint pathway that suppresses immune responses, thereby supporting anti-tumor immune activity. It is being evaluated in combination with other immunotherapies rather than as a single agent.
Domvanalimab is being developed by Gilead Sciences, Inc., which trades on the Nasdaq under the ticker GILD. Gilead is the sponsor of the clinical program evaluating the antibody in lung cancer and head and neck cancer. The asset is identified in chemical databases under the ChEMBL ID CHEMBL4650392.
Domvanalimab is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA or any other regulatory authority for any indication. The ongoing studies are randomized, controlled Phase 2 trials in advanced non-small cell lung cancer and head and neck squamous cell carcinoma.
Domvanalimab is being evaluated in two Phase 2 studies. NCT05676931 is a 400-participant trial in advanced non-small cell lung cancer across the United States, Europe, and Asia. NCT06727565 is a 39-participant substudy in head and neck squamous cell carcinoma regardless of PD-L1 expression status. Both trials are currently active but not recruiting.
Yes, Domvanalimab is also referred to as Domvanalimab (DOM). DOM is simply an abbreviated form of the drug's name used in study documentation and scientific literature. Both names refer to the same investigational anti-TIGIT monoclonal antibody developed by Gilead Sciences, Inc. for advanced non-small cell lung cancer and head and neck squamous cell carcinoma.