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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07601243
- Acronym / sponsor ID
- GH31C101A
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1a: Monotherapy Dose Escalation | Experimental | Drug: GS-2426Participants 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. |
| Phase 1b: Monotherapy Dose Expansion | Experimental | Drug: GS-2426Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GS-2426Administered Orally | Drug | Phase 1a: Monotherapy Dose Escalation, Phase 1b: Monotherapy Dose Expansion |
Primary outcome
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE)
Time frame: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Clinical Laboratory Abnormalities
Time frame: First dose up to 30 days post last dose (up to 105 weeks)
Percentage of Participants Experiencing Any Dose-limiting Toxicities (DLTs)
Time frame: First dose up to 21 days post first dose
Maximum Tolerated Dose (MTD)/Maximum Administered Dose (MAD)
Time frame: First dose up to 21 days post first dose
Recommended Phase 2 Dose (RP2D)
Time frame: Predose to end of study (up to 105 weeks)
4 secondary outcomes
Plasma Concentration of GS-2426
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Pharmacokinetic (PK) Parameter: AUC0-24h of GS-2426
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameters: Cmax of GS-2426
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
PK Parameters: Tmax of GS-2426
Time frame: Predose and postdose up to end of treatment (up to 105 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Gilead Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gilead Clinical Study Information Center contact
Gilead Study Director study director
Gilead Sciences
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GS-2426 in people with Advanced Solid Tumors, run by Gilead Sciences at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilead Clinical Study Information Center (1-833-445-3230 (GILEAD-0), GileadClinicalTrials@gilead.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAE) (time frame: First dose up to 30 days post last dose (up to 105 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.