Recruiting
Phase 1

GS-1206

Sponsor:

Gilead Sciences

Code:

NCT07703878

Conditions

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GS-1206

Study Details

Brief summary:

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.

Conditions

Solid Tumor

Study ID

NCT07703878

Start date

Jul 17, 2026

Status verified date

Sep, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • All individuals must have a tumor with protocol-specified mutation as determined by local health-authority approved test.
  • For Part A (including backfill cohorts): Individuals with histologically confirmed advanced or metastatic solid tumors who have progressed following treatment in the advanced or metastatic setting known to confer clinical benefit, unless the individual refused, is intolerant to, or is not eligible for standard-of-care (SOC) treatment.
  • For Part B dose expansion, individuals with protocol-specified tumor types will be enrolled.

Key Exclusion Criteria:

  • Use of any of the therapies listed below within the specified time frames:

1. Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
2. Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
3. Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
4. Hormonal or other adjunctive therapy for cancers other than the cancer under evaluation in this study that started within 14 days prior to planned Cycle 1 Day 1 are not permitted. Exceptions: hormonal therapy, bisphosphonates, somatostatin analogues, and leuprolide are permitted if started at least 14 days prior to Cycle 1 Day 1.
5. Major surgery (excluding minor procedures, eg, placement of vascular access, gastrointestinal/biliary stent, biopsy) within 28 days prior to Cycle 1 Day 1, and any toxicity or complications have recovered to Grade 1 or less.
6. Radiation therapy within 21 days prior to Cycle 1 Day 1. Exception: limited (eg, pain palliation) radiation therapy is allowed if any radiation associated toxicity is resolved to Grade 1 or less, and the radiation is not administered to a target lesion.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Enrollment

302 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: Dose Escalation

Participants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles.

experimental: Part B: Dose Expansion

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.

Interventions

GS-1206

Administered Orally

Primary outcome measure

  • Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs) [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: First dose date up to 30 days post last dose (Up to 3 years) ]

Central Contacts and Locations

Central contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)GileadClinicalTrials@gilead.com

Locations

START Midwest, LLC

Recruiting

Grand Rapids, Michigan, United States, 49546

NEXT Oncology

Recruiting

San Antonio, Texas, United States, 78229

NEXT Oncology Dallas

Recruiting

Texas City, Texas, United States, 75039

START San Antonio, LLC

Recruiting

Texas City, Texas, United States, 78229

More Information

Sponsor

Gilead Sciences

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Gilead Sciences on 2026-09-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.