174 Participants NeededMy employer runs this trial

GS-2426 for Solid Tumors

Recruiting at 3 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Why 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?

GS

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

I have advanced solid cancer and no standard treatments work or are suitable for me.
My tumor is MTAP-deficient.
My organs are working well enough for treatment.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

Participants receive escalating doses of GS-2426 monotherapy until disease progression or up to a maximum of 105 weeks

Up to 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

Up to 105 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

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

Group I: Phase 1b: Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Group II: Phase 1a: Monotherapy Dose EscalationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials
1,150
Recruited
878,000+
Daniel O'Day profile image

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger profile image

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1.

goldmansachs.com

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Goldman Sachs: Home

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finance.yahoo.com

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GS Goldman Sachs Group, Inc. This is a 0.68% rise. Closed at $1.04K. The stock has since risen $2.39 in after-hours trading.

Goldman Sachs Group Inc (GS) Stock Price & News

Goldman Sachs Group Inc $1,032.58 -2.62% ( (+4.98) bedtimeAfter. Open $1,062.04 High $1,068.04 Low $1,030.78 Mkt. Quarterly dividend $5.00

5.

seekingalpha.com

seekingalpha.com/symbol/GS

GS The Goldman Sachs Group, Inc. Stock Price & Overview

The Goldman Sachs Group, Inc.'s stock symbol is GS and currently trades under NYSE. It's current price per share is approximately $1,032.58. What are ...

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

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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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