Study of GS-2426 in Participants With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GS-2426.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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).
Interventions
- Drug GS-2426
Administered Orally
Primary outcome measures
- 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)]
Secondary outcome measures (4)
- 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)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 4 centers
- START Midwest — Grand Rapids
- START Astera, LLC — East Brunswick
- Memorial Sloan Kettering Cancer Center — New York
- START San Antonio, LLC — San Antonio
Identifiers
NCT: NCT07601243 · GH31C101A