A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors

NCT07703878 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: GS-US-723-7652
• Study Type: interventional
• Target: 302
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (3)

• 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)

Secondary Outcomes (9)

• 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

  Up to 2 years

• PK Parameter: Tmax of GS-1206 and its Metabolites

  Up to 2 years

• PK Parameter: AUC0-24h of GS-1206 and its Metabolites

  Up to 2 years

• Objective Response Rate (ORR)

  Up to 3 years

Study Arms (2)

Part A: Dose Escalation

EXPERIMENTAL

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

Drug: GS-1206

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.

Drug: GS-1206

Interventions

GS-1206 DRUG

Administered Orally

Part A: Dose Escalation; Part B: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Use of any of the therapies listed below within the specified time frames:
• Investigational drugs (drugs not marketed for any indication) within 28 days prior to Cycle 1 Day 1.
• Anticancer biologic agent or immunotherapy within 28 days prior to Cycle 1 Day 1.
• Anticancer chemotherapy or targeted approved small molecule therapy within 21 days prior to Cycle 1 Day 1, or 42 days for nitrosoureas or mitomycin.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Central Study Contacts

Gilead Clinical Study Information Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share