Advanced Solid TumorsPhase 1NCT07601243
Study of GS-2426 in Participants With Advanced Solid Tumors
A Phase 1 study testing GS-2426 in people with Advanced Solid Tumors, run by Gilead Sciences at 6 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- GS-2426
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 2 Jun 2026to Jan 2029
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants 18 years of age or older (≥ 19 years old for participants in South Korea).
- Histologically or cytologically confirmed advanced malignant solid tumors, who have progressed on, are intolerant to or are ineligible for standard therapy, or have no standard treatment options.
- Participant tumors are methylthioadenosine phosphorylase (MTAP)-deficient.
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- All participants must provide a pretreatment tumor tissue sample.
Who cannot join
- Participants with plans to breastfeed during the study period or within 7 days following the last dose of study intervention.
- Have not recovered (ie, returned to Grade 1 or baseline) from clinically significant adverse events (AEs) due to a previously administered agent or a previous intervention as assessed by the investigator.
- Active second malignancy. Individuals with a history of malignancy who have been completely treated with no evidence of active cancer for 5 years prior to enrollment, or individuals with surgically cured tumors with low risk of recurrence may be enrolled.
- Requirement for ongoing therapy with any prohibited medications .
- Prior therapy with a protein arginine methyltransferase 5 (PRMT5) inhibitor or methionine adenosine transferase 2a (MAT2A) inhibitor.
- Have serious infection requiring antibiotics within 14 days prior to the first dose.
- Uncontrolled concurrent diseases
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Gilead Clinical Study Information Center contact
6 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
- Recruiting
START Astera, LLC
East Brunswick, New Jersey, 08816
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
- Recruiting
START San Antonio, LLC
San Antonio, Texas, 78229
Spain1 site, 1 recruiting
- Recruiting
START Madrid- CIOCC - Hospital HM Sanchinarro
Madrid, 28050
About this study
Official title: A Phase 1, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants With Advanced MTAP-Deleted Solid Tumors
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).
- Conditions
- Advanced Solid Tumors
- Being tested
- GS-2426
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-2426Drug
Administered Orally
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: GS-2426 |
| 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. Receives: Drug: GS-2426 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)
Measured: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Measured: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)
Measured: First dose up to 21 days post first dose
Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
Measured: First dose up to 21 days post first dose
Recommended Phase 2 Dose (RP2D)
Measured: Predose to end of study (up to 105 weeks)
Secondary outcomes (4)
Plasma Concentration of GS-2426
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Predose and postdose up to end of treatment (up to 105 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start2 Jun 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilead Study Director, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601243
- Sponsor's protocol ID
- GH31C101A
- Status last verified
- Oct 2026
- First submitted
- 15 May 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No