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GB1211 · 3 trials · 4 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).
Timepoints for PK sampling Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Timepoints for PK sampling Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Timepoints for PK sampling for Period 1: Day 1: pre-dose and at hrs 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 2: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose. Period 3: Day 1: pre-dose and at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 24 (Day 2), 48 (Day 3), 72 (Day 4), and 96 (Day 5) post-dose.
Study Period 1: Pre-dose (single sample) and at \[0 to 6 h\], \[6 to 12 h\] (Day 1), \[12 to 24 h\] (Day 2), \[24 to 48 h\] (Day 3), \[48 to 72 h\] (Day 4), \[72 to 96 h\] (Day 5) post-dose.
Study Period 1: Pre-dose (single sample) and at \[0 to 6 h\], \[6 to 12 h\] (Day 1), \[12 to 24 h\] (Day 2), \[24 to 48 h\] (Day 3), \[48 to 72 h\] (Day 4), \[72 to 96 h\] (Day 5) post-dose.
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. |
| A 100mg GB1211 tablet, fasted | ACTIVE_COMPARATOR | Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fasted conditions (n=4 per period) |
| B 100 mg GB1211 capsules, fasted | ACTIVE_COMPARATOR | Single dose of 100 mg GB1211 as two capsules (50 mg strength) under fasted conditions (n=4 per period) |
| C 100 mg GB1211 tablet, fed | ACTIVE_COMPARATOR | Single dose of 100 mg GB1211 as a tablet (100 mg strength) under fed conditions (n=4 per period) |
| 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 for use in metastatic melanoma and head and neck squamous cell carcinoma. It is also being evaluated in healthy subjects for safety, tolerability, and pharmacokinetics. The drug is in Phase 2 clinical development for the oncology indications.
GB1211 targets galectin-3, a protein involved in various cellular processes. By inhibiting galectin-3, the drug aims to modulate pathways relevant to cancer. This mechanism is being explored in the context of metastatic melanoma and head and neck squamous cell carcinoma.
GB1211 is being developed by Galecto, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol GLTO. Galecto is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in oncology indications.
GB1211 is in Phase 2 clinical development. It is being studied in a Phase 2 trial for metastatic melanoma and head and neck squamous cell carcinoma. The drug is investigational and has not been approved by regulatory authorities. Earlier Phase 1 trials have been completed.
GB1211 is being studied in a Phase 2 trial (NCT05913388) comparing GB1211 plus pembrolizumab versus pembrolizumab and placebo in patients with metastatic melanoma and head and neck squamous cell carcinoma. Two Phase 1 trials (NCT03809052 and NCT05747573) have been completed, evaluating safety, tolerability, and pharmacokinetics in healthy subjects.
GB1211 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial data. It is being developed by Galecto, Inc. under this designation, and no other names are associated with it in the available information.