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This is a phase I/II study to investigate the safety, tolerability, and preliminary efficacy of GLS-012 monotherapy and in combination with GLS-010 in subjects with advanced solid rumor after progression on standard treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose escalation and expansion of GLS-012 monotherapy and combination with GLS-010 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLS-012 | Drug | In the dose escalation stage of GLS-012 monotherapy, RP2D will be determined. All subjects will receive GLS-012 intravenously Q3W. In the expansion stage of GLS-012 monotherapy, subjects will receive up to 17 doses of GLS-012 at the RP2D administered Q3W. In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in combination with a fixed-dose GLS-010 will be determined. All subjects will receive GLS-012 and GLS-010 intravenously Q3W. In the expansion stage of GLS-012 combination with GLS-010, subjects will receive up to 35 doses of GLS-012 at the RP2D and GLS-010 at a fixed dose administered Q3W. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with a Dose-Limiting Toxicity (DLT) and MTD in the dose escalation stage | Up to 21 days after the first dose | |
| Number of participants with treatment-related adverse events of GLS-012 monotherapy and in combination with GLS-010 in the expansion stage as assessed by CTCAE V5.0 | Up to approximately 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of GLS-012 monotherapy and in combination with GLS-010 | Up to approximately 4.5 months | |
| Elimination half-life (T1/2) of GLS-012 monotherapy and in combination with GLS-010 | Up to approximately 4.5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Receptor occupancy (RO) of GLS-012 in the dose escalation stage of GLS-012 monotherapy | Up to approximately 4.5 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| C000719848 | zimberelimab |
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|
| GLS-010 | Drug | In the dose escalation stage of GLS-012 combination with GLS-010, RP2D of GLS-012 in combination with a fixed-dose GLS-010 will be determined. All subjects will receive GLS-012 and GLS-010 intravenously Q3W. In the expansion stage of GLS-012 combination with GLS-010, subjects will receive up to 35 doses of GLS-012 at the RP2D and GLS-010 at a fixed dose administered Q3W. |
|
| Objective response rate (ORR) | Up to approximately 24 months |
| Disease control rate (DCR) | Up to approximately 24 months |
| Preliminary anti-tumor activity: Duration of response (DOR), time to response (TTR), progression free survival (PFS), overall survival (OS) | Up to approximately 24 months |
| Duration of response (DOR) | Up to approximately 24 months |
| Time to response (TTR) | Up to approximately 24 months |
| Progression free survival (PFS) | Up to approximately 24 months |
| Overall survival (OS) | Up to approximately 24 months |