Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07408063 | A Comprehensive Multiomic Biomarker Evaluation Across Two Single-arm Cohorts to Elucidate Mechanisms of Response and Resistance in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) | PHASE2 | RECRUITING | 30 | — | — | Apr 27, 2026 | Mar 1, 2031 | Apr 29, 2026 | 1 | Canada |
Find biomarkers (biopsy + ctDNA) linked to response/resistance to GSK5764227 with or without dostarlimab.
| Arm | Type | Description |
|---|---|---|
| Arm A - GSK5764227 | EXPERIMENTAL | All participants will receive GSK5764227 monotherapy at a starting dose of 8 mg/kg intravenously every 3 week (IV Q3W) in a 21-day treatment cycle. |
| Arm B - GSK5764227 + Dostarlimab | EXPERIMENTAL | All participants will receive a combination of GSK5764227 (8 mg/kg IV Q3W) and dostarlimab (500 mg IV Q3W). |
| Name | Type | Description |
|---|---|---|
| GSK5764227 | DRUG | GSK5764227 is a new kind of drug known as an antibody drug conjugate (ADC). GSK5764227 works by recognizing and attaching to a substance known as B7-H3 that is found on the surface of certain tumor cells. Once GSK5764227 binds to B7-H3, it enters the tumor cell and releases a chemotherapy-type drug (known as GSK5757810) which has been shown to damage and kill tumor cells. |
| Dostarlimab | DRUG | Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). Dostarlimab is designed to help your immune system by attaching to a protein called PD-1 and stopping one of the signals that keeps your immune system from recognizing the cancer. This may help your immune system attack and destroy the cancer cells. Dostarlimab is approved in some countries to treat patients with endometrial cancer (cancer of the uterus) that is advanced or has relapsed. It is also approved in the United States for all solid cancers that have a particular tumor genetic characteristic and have worsened during or after previous treatment. Dostarlimab has not yet been approved by Health Canada to treat head and neck cancer. |
Inclusion Criteria: 1. Written informed consent 2. At least 18 years old at the time of signing Informed Consent Form (ICF). 3. Histologically or cytologically confirmed Head and Neck Squamous Cell Carcinoma (HNSCC) with evidence of metastatic or locally recurrent/advanced disease not amenable to c...