GS-2426 for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and tolerability of a drug called GS-2426 for individuals with advanced solid tumors lacking the enzyme MTAP. The primary goal is to assess the safety of GS-2426 and determine the optimal dose for future studies. Participants will receive the drug until their disease progresses or for up to 105 weeks. Suitable candidates have advanced solid tumors unresponsive to standard treatments and tumors missing the MTAP enzyme. As a Phase 1 trial, this research aims to understand how GS-2426 works in people, offering participants the opportunity to be among the first to receive this new treatment.
Is there any evidence suggesting that GS-2426 is likely to be safe for humans?
Research shows that GS-2426 is in early testing for individuals with advanced solid tumors lacking the enzyme MTAP. This Phase 1 trial primarily tests the drug's safety and determines the appropriate dose. Consequently, there is limited information on how well participants can tolerate GS-2426.
Early trials like this often carry higher risks because the drug is being tested in humans for the first time. The main goal is to identify any major side effects and determine the highest dose that participants can safely handle. As an initial study, there is limited information on potential side effects or patient responses to the treatment.12345Why do researchers think this study treatment might be promising?
GS-2426 is unique because it targets solid tumors with a novel approach that distinguishes it from traditional chemotherapy and immunotherapy treatments. Unlike existing options that often rely on broadly attacking cancer cells, GS-2426 may offer a more precise mechanism of action, potentially leading to fewer side effects and better targeting of tumor cells. Researchers are excited because this specificity might not only improve treatment effectiveness but also enhance patient quality of life by minimizing damage to healthy cells.
What evidence suggests that GS-2426 might be an effective treatment for MTAP-deleted solid tumors?
Research has shown that GS-2426 is being tested in individuals with advanced solid tumors that have a specific genetic change called MTAP deletion. This genetic change, common in several cancer types, can accelerate tumor growth. GS-2426 targets a pathway that these cancer cells rely on due to the MTAP deletion. Early lab studies have indicated it might slow the growth of these cancer cells. In this trial, participants will receive GS-2426 monotherapy in two phases: a dose escalation phase and a dose expansion phase. Researchers aim to assess its safety and effectiveness in humans, as studies in this area remain limited.678910
Who Is on the Research Team?
Gilead Study Director
Principal Investigator
Gilead Sciences
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors that lack the MTAP gene, whose cancer has worsened or who can't get standard treatments. Participants need to have good organ function and be able to provide a tumor sample.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monotherapy Dose Escalation
Participants receive escalating doses of GS-2426 monotherapy until disease progression or up to a maximum of 105 weeks
Monotherapy Dose Expansion
Participants receive GS-2426 monotherapy at the recommended dose until disease progression or up to a maximum of 105 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- GS-2426
Trial Overview
The study is testing GS-2426, a new drug, in people with MTAP-deleted advanced solid tumors. The main goal is to find out how safe it is and what dose should be used in future studies.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gilead Sciences
Lead Sponsor
Daniel O'Day
Gilead Sciences
Chief Executive Officer since 2019
MBA from Columbia University
Dietmar Berger
Gilead Sciences
Chief Medical Officer
MD and PhD from Albert-Ludwigs University School of Medicine
Citations
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Study of GS-2426 in Participants With Advanced Solid ...
The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid tumors
Study of GS-2426 in Participants With Advanced Solid ...
The primary objective of this study is to evaluate the safety and tolerability of GS-2426 in participants with MTAP-deleted advanced solid ...
A Study of GS-2426 in People With Solid Tumor Cancer
Full Title A Phase 1, Multicenter, Open-Label Clinical Study to Evaluate the Safety and Tolerability of GS-2426 in Participants with Advanced MTAP-Deleted ...
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trialscreen.org
trialscreen.org/trials/phase-1-gs-2426-participants-advanced-solid-tumors-trial-nct07601243A Phase 1 interventional study of GS-2426 in advanced ...
A first-in-human study testing a new cancer drug called GS-2426 in patients with advanced solid tumors that have a specific genetic change (MTAP deletion)
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theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/GILD/pressreleases/3641502/gileads-gs-2426-phase-1-trial-targets-mtap-deleted-tumors-what-investors-should-know/Gilead's GS-2426 Phase 1 Trial Targets MTAP-Deleted ...
Phase 1 safety trials carry high risk, but a positive safety and dose‑finding readout could support valuation upside and strengthen Gilead's ...
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