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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05913388 | GB1211 and Pembrolizumab Versus Pembrolizumab and Placebo in Patients With Metastatic Melanoma and Head and Neck Squamous Cell Carcinoma | PHASE2 | RECRUITING | 92 | — | — | Feb 29, 2024 | Feb 1, 2030 | Apr 13, 2026 | 1 | United States |
Determine the response of Gal-3 inhibitor and pembrolizumab versus pembrolizumab monotherapy (plus placebo) in patients with metastatic melanoma or head and neck squamous cell carcinoma (HNSCC).
| Arm | Type | Description |
|---|---|---|
| GB1211 + Pembrolizumab | EXPERIMENTAL | GB1211 will be administered orally twice a day at 400mg in combination with standard pembrolizumab treatment. |
| Pembrolizumab Monotherapy | PLACEBO_COMPARATOR | Placebo will have the same appearance as GB1211 and administered orally twice a day in combination with standard pembrolizumab treatment. |
| Name | Type | Description |
|---|---|---|
| GB1211 | DRUG | Administered orally twice daily at 100mg. |
| Pembrolizumab | DRUG | Administered at a fixed dose of 200 mg every 3 weeks intravenously. |
| Placebo | DRUG | Administered orally twice daily at 100mg. |
Inclusion Criteria: * Patients with unresectable or metastatic melanoma including unknown primary or mucosal melanomas. Histological confirmation of melanoma will be required by previous biopsy or cytology. Patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with dis...