Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GB1211 · 2 trials · 3 indications
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).
The number of participants in each arm that report Adverse Events (AEs)
| 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. |
| A1 - 5 mg GB1211 single dose and Placebo | EXPERIMENTAL | 6 healthy subjects are administered 5 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
| A2 - 20 mg GB1211 single dose and Placebo | EXPERIMENTAL | 6 healthy subjects are administered 20 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
| A3 - 50 mg GB1211 single dose (food effect cohort) and Placebo | EXPERIMENTAL | 6 healthy subjects are administered 50 mg of GB1211 capsules orally as a single dose. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. Each subject will participate in 2 treatment periods separated by a minimum of 7 days. In Treatment Period 1 doses will be administered in the fasted state, in Treatment Period 2 doses will be administered 30 minutes after the start of a high fat breakfast. Subjects will receive the same treatment in both periods. |
| A4 - 100 mg GB1211 single dose and Placebo | EXPERIMENTAL | 6 healthy subjects are administered 100 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
| A5 - 200 mg GB1211 single dose and Placebo | EXPERIMENTAL | 6 healthy subjects are administered 200 mg of GB1211 capsules orally as a single dose in the fasted state. 2 subjects receive placebo. 2 subjects (1 active and 1 placebo) will be dosed at least 24 hours before the remaining subjects, where continuation to dose the remaining subjects will be at the Investigator's discretion. |
| B1 - GB1211 multiple ascending doses, 50mg BID and Placebo | EXPERIMENTAL | GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule. |
| B2 - GB1211 multiple ascending doses, 100mg BID and Placebo | EXPERIMENTAL | GB1211 administered orally twice daily over 10 days. 8 healthy subjects received GB1211 and 3 subjects will receive placebo. Following review of data in Part A (Cohorts A1 to A6), subjects received twice daily (BID) doses under fasted conditions on Days 1 to 9, inclusive, and a final single dose administration on the morning of Day 10 in accordance with the randomisation schedule.. |
| A6 - 50mg GB1211 single dose and Placebo | EXPERIMENTAL | 8 healthy subjects are administered 50 mg (10 x 5mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. |
| A7 - 400 mg GB1211 single dose and Placebo | EXPERIMENTAL | 8 healthy subjects are administered 400 mg (8 x 50mg capsules) or placebo without sentinel dosing. Optional cohort, as was added following dose-escalation analysis. |
| Part A - Placebo for GB1211 | EXPERIMENTAL | In Part A - 2 subjects from each arm (A1-A5) will receive placebo. |
| Part B - Placebo for GB1211 (BID) | EXPERIMENTAL | Part B - 3 subjects from each arm B1 and B2 will receive placebo. |
| 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...
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GB1211 is an investigational small molecule being studied in metastatic melanoma and head and neck squamous cell carcinoma. It is also being evaluated for safety and tolerability. It is not approved for any indication and remains in clinical development.
GB1211 targets galectin-3, a protein involved in tumor progression and immune regulation. By binding galectin-3, the drug is designed to modulate pathways that may enhance antitumor immunity, particularly in combination with checkpoint inhibitors such as pembrolizumab.
GB1211 is being developed by Damora Therapeutics, Inc., which trades under the ticker DMRA. The company is the sponsor of the clinical program evaluating the drug in metastatic melanoma and head and neck squamous cell carcinoma.
GB1211 is in Phase 2 clinical development. A Phase 1 first-in-human study in healthy subjects has been completed, and a Phase 2 trial in patients with metastatic melanoma and head and neck squamous cell carcinoma is currently recruiting.
GB1211 has been studied in two clinical trials. The Phase 2 trial NCT05913388 is evaluating GB1211 plus pembrolizumab versus pembrolizumab plus placebo in metastatic melanoma and head and neck squamous cell carcinoma. The completed Phase 1 trial NCT03809052 assessed safety, tolerability, and pharmacokinetics in healthy subjects.
No, GB1211 is not approved by the FDA. It is an investigational drug currently in Phase 2 clinical development for metastatic melanoma and head and neck squamous cell carcinoma. Approval has not been granted for any indication.