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GS-1206

Phase 1

Solid Tumor | Small molecule | Oncology |Gilead Sciences, Inc.|Last Updated: Aug 10, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment302

FDA Designations

No designations recorded

Clinical trial landscape

GS-1206 · 1 trial · 1 indication

Phase 1 1
NCT07703878A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid TumorsSolid Tumor
RECRUITING302 Analytics
PHASE1RECRUITING
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A: Dose EscalationEXPERIMENTALParticipants will receive escalating doses of GS-1206 monotherapy one time daily up to 35 cycles.
Part B: Dose ExpansionEXPERIMENTALParticipants 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

NameTypeDescription
GS-1206DRUGAdministered Orally
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

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 ...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Recent Changes (Last 90 Days)

LOWAug 11, 2026NCT07703878Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 11, 2026NCT07703878Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 11, 2026NCT07703878Status: NOT_YET_RECRUITING → RECRUITING
LOWJul 15, 2026NCT07703878NEW_TRIAL: changed
LOWJul 15, 2026NCT07703878NEW_TRIAL: changed

Frequently asked questions about GS-1206

What is GS-1206 used for?

GS-1206 is an investigational small molecule being developed for the treatment of solid tumors. It is currently in Phase 1 clinical development, with a study evaluating its safety and antitumor activity in adults with solid tumors.

Who makes GS-1206?

GS-1206 is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker GILD. The company is conducting a Phase 1 trial of GS-1206 in adults with solid tumors.

What phase is GS-1206 in?

GS-1206 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 1 study is currently recruiting participants to evaluate its safety and antitumor activity in solid tumors.

What clinical trials is GS-1206 in?

GS-1206 is being studied in a Phase 1 clinical trial with the identifier NCT07703878. The trial is titled "A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors" and is currently recruiting participants in the United States.

Is GS-1206 being studied in a controlled trial?

Yes, the Phase 1 clinical trial of GS-1206 is a controlled study. The trial is not randomized or double-blinded, and it is enrolling approximately 302 adults aged 18 years and older with solid tumors.