What this study is
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).
What's being tested
- GS-2426
Intervention · DRUG
Administered Orally
Study details
- 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
- Sponsor
- Gilead Sciences
- Conditions
- Advanced Solid Tumors
- Enrolling
- 174 people
- Starts
- 2026-06-02
- Est. completion
- 2029-01
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (6)
6 openBeth Israel Deaconess Medical Center
Boston, Massachusetts, United States
RecruitingSTART Midwest
Grand Rapids, Michigan, United States
RecruitingSTART Astera, LLC
East Brunswick, New Jersey, United States
RecruitingMemorial Sloan Kettering Cancer Center
New York, New York, United States
RecruitingSTART San Antonio, LLC
San Antonio, Texas, United States
Recruiting
1 site outside the US
START Madrid- CIOCC - Hospital HM Sanchinarro
Madrid, Spain
Recruiting
Study team
Sponsor
Gilead Sciences
Study ID GH31C101A
Study director
Gilead Study Director
Gilead Sciences
CONTACT
Gilead Clinical Study Information Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.