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The goal of this clinical study is to learn more about the study drug GS-1206, including its safety, tolerability, and antitumor activity in adult participants with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Dose Escalation | Experimental | Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles. |
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| Part B: Dose Expansion | Experimental | Participants will be enrolled in different indication specific cohorts. Participants will receive GS-1206 monotherapy at the recommended dose one time daily up to 35 cycles. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-1206 | Drug | Administered Orally |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) | First dose up to 21 days post first dose | |
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) Based on National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. | First dose date up to 30 days post last dose (Up to 3 years) | |
| Percentage of Participants Experiencing Clinical Laboratory Abnormalities Based National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v6.0. | First dose date up to 30 days post last dose (Up to 3 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentrations of GS-1206 and its Metabolites After Single Dose and Repeated Dose Administration | Predose and postdose up to end of treatment (up to 2 years) | |
| Pharmacokinetic (PK) Parameter: Cmax of GS-1206 and its Metabolites | Cmax is defined as the maximum observed concentration of drug |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Use of any of the therapies listed below within the specified time frames:
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 |
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| Up to 2 years |
| PK Parameter: Tmax of GS-1206 and its Metabolites | Tmax is defined as the time (observed time point) of Cmax | Up to 2 years |
| PK Parameter: AUC0-24h of GS-1206 and its Metabolites | AUC0-24h is defined as the partial area under the concentration versus time curve from time 0 to time 24 | Up to 2 years |
| Objective Response Rate (ORR) | ORR is defined as the percentage of participants who have measurable disease at baseline and have achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and assessed by the investigator at the local site. | Up to 3 years |
| Duration of Response (DOR) | DOR is defined as the measurement from the time of first response (CR or PR) as assessed by the investigator at local site, per RECIST v1.1 until the date of first documented disease progression or death, whichever occurs first. | Up to 3 years |
| Best Overall Response (BOR) | BOR is defined as the best response recorded from first dosing date until disease progression identified by RECIST v1.1, death, or the participant discontinues study treatment, whichever occurs first. | Up to 3 years |
| Progression-Free Survival (PFS) | PFS is defined as the time from first dosing date until disease progression or death from any cause, whichever comes first as measured per RECIST v1.1. | Up to 3 years |
| Disease Control Rate (DCR) | DCR is defined as the measurement by the percentage of participants who achieve confirmed response of CR or PR or stable disease. | Up to 3 years |