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The goal of this clinical study is to learn more about the study drug GS-2426, and how safe and tolerable it is in participants with advanced methylthioadenosine phosphorylase (MTAP)-deleted solid tumors.
The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors and to determine the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended phase II dose (RP2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1a: Monotherapy Dose Escalation | Experimental | Participants will receive escalating doses of GS-2426 monotherapy, until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 week, whichever occurs first. |
|
| Phase 1b: Monotherapy Dose Expansion | Experimental | Participants will be enrolled in different indication-specific cohorts. Participants will receive GS-2426 monotherapy at the recommended dose until disease progression, or until the participant meets other study drug discontinuation criteria as specified in protocol, or up to a maximum of 105 weeks, whichever occurs first. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-2426 | Drug | Administered Orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) | First dose up to 30 days post last dose (up to 105 weeks) | |
| Percentage of Participants Experiencing Clinical Laboratory Abnormalities | First dose up to 30 days post last dose (up to 105 weeks) | |
| Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs) | First dose up to 21 days post first dose | |
| Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD) | First dose up to 21 days post first dose | |
| Recommended Phase 2 Dose (RP2D) | Predose to end of study (up to 105 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of GS-2426 | Predose and postdose up to end of treatment (up to 105 weeks) | |
| Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426 | AUC0-24h is defined as the area under concentration versus time from 0 to 24 hours. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilead Clinical Study Information Center | Contact | 1-833-445-3230 (GILEAD-0) | GileadClinicalTrials@gilead.com |
| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Astera, LLC | Recruiting | East Brunswick | New Jersey | 08816 | United States | |
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| Label | URL |
|---|---|
| Gilead Clinical Trials Website | View source |
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| Predose and postdose up to end of treatment (up to 105 weeks) |
| PK Parameters: Cmax of GS-2426 | Cmax is defined as the maximum observed plasma drug concentration. | Predose and postdose up to end of treatment (up to 105 weeks) |
| PK Parameters: Tmax of GS-2426 | Tmax is defined as the time to peak plasma drug concentration of GS-2426. | Predose and postdose up to end of treatment (up to 105 weeks) |
| START San Antonio, LLC |
| Recruiting |
| San Antonio |
| Texas |
| 78229 |
| United States |