GS-5319 for Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Gilead Sciences

Must not be taking: Antibiotics, Antifungals, Antivirals

Disqualifiers: Active second malignancy, Pregnancy, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

178 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, GS-5319, to determine the best dose and assess its safety for people with advanced solid tumors. The study targets tumors lacking a specific enzyme, methylthioadenosine phosphorylase (MTAP), which normally aids cell growth. Participants should have a solid tumor unresponsive to standard treatments or be unable to use those treatments. The trial examines how different doses of GS-5319 affect the body to identify the optimal amount for future studies. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not need ongoing therapy with any prohibited medications, but it doesn't specify which medications are prohibited. It's best to discuss your current medications with the trial team to see if they are allowed.

Is there any evidence suggesting that GS-5319 is likely to be safe for humans?

Research shows that GS-5319 is currently being tested in individuals with certain solid tumors. This Phase 1 study primarily assesses the treatment's safety and tolerability. Detailed safety information remains limited as testing continues. In these early stages, researchers closely monitor any new treatment for side effects and patient responses. If deemed safe and well-tolerated, the treatment will proceed to further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

GS-5319 is unique because it offers a novel approach to cancer treatment by potentially targeting cancer cells more precisely than current options. Most treatments for cancer, like chemotherapy, attack rapidly dividing cells but can also harm healthy cells, leading to significant side effects. GS-5319, however, is being explored for its ability to focus more directly on cancer cells, possibly reducing collateral damage to normal cells. Researchers are excited about this treatment because it might provide a more effective and less harmful way to manage cancer, opening new doors for patient care.

What evidence suggests that GS-5319 might be an effective treatment for cancer?

Research has shown that GS-5319 targets a specific change in a gene related to the MTAP enzyme. This enzyme plays a crucial role in normal cell growth, and some solid tumors lack it. Although human data on GS-5319 remains limited, the treatment is designed to address tumors with this genetic change, potentially increasing its effectiveness for these cancers. Participants in this trial will receive GS-5319 monotherapy, either in a dose escalation phase to determine the recommended dose or in a dose expansion phase at the recommended dose. The treatment is still in early testing, so its effectiveness is not yet known. However, focusing on the MTAP deletion offers a promising approach to treating these specific tumors. ^{1 2 3 6 7}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

Adults with solid tumors that lack the MTAP enzyme due to a specific gene alteration can join this trial. They must have tried standard treatments without success, be intolerant to them, or ineligible for such therapies. Participants need normal organ function and an ECOG score of 0-1, indicating they are fully active or restricted in physically strenuous activity but ambulatory.

Inclusion Criteria

Key

I can provide tissue samples from my tumor before starting treatment.

My cancer has worsened despite treatment, or I can't tolerate/qualify for standard treatments.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment - Dose Escalation

Participants receive escalating doses of GS-5319 monotherapy to determine the recommended dose for dose expansion phase

Up to 105 weeks

Treatment - Dose Expansion

Participants receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase

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-5319

Trial Overview The study is testing GS-5319's safety and tolerability in adults with MTAP-deleted advanced solid tumors. It aims to find the highest dose patients can take without serious side effects (MTD/MAD) and suggest a dose for further studies (RDE).

How Is the Trial Designed?

Group I: Part B: GS-5319 Monotherapy Dose Expansion Experimental Treatment 1 Intervention

Participants will be enrolled in different cohorts based on the selected indications to receive GS-5319 monotherapy at the recommended dose during the monotherapy dose expansion phase.

Group II: Part A: GS-5319 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Participants will receive escalating doses of GS-5319 monotherapy, until disease progression, or until the participants meets other study drug discontinuation criteria as specified in protocol or up to 105 weeks, whichever occurs first to determine the recommended dose for dose expansion phase.

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

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

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07128303

Study of GS-5319 in Adults With Solid Tumors The primary objectives of the study are to assess the safety and tolerability of GS-5319 in participants with methylthioadenosine phosphorylase (MTAP)-deleted ...

2. gilead.com gilead.com/science/pipeline

Virology, Inflammation, & Oncology Pipeline We are advancing a world-class oncology portfolio that includes some of the most promising targets in cancer treatment today. Advanced Cancers. GS-5319.

3. linkedin.com linkedin.com/posts/the-start-center-for-cancer-research_mtap-oncology-clinicalresearch-activity-7381307715525955584-uJGb

San Antonio doses first patient in GS-5319 trial for MTAP ... Scientists have discovered a new way to make breast cancer drugs more effective in younger women Recent research has found that ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11374285/

Revolutionizing triple-negative metastatic breast cancer ... The clinical benefit rate was 45.4%, median progression-free survival was 5.5 months, and overall survival was 13 months. As a result of this trial, Sacituzumab ...

5. nature.com nature.com/articles/s41467-024-50558-9

Sacituzumab Govitecan in patients with breast cancer brain ... Sacituzumab Govitecan (SG) is an antibody-drug conjugate that has demonstrated efficacy in patients with TROP-2 expressing epithelial cancers.

6. oncologypipeline.com oncologypipeline.com/apexonco/new-myeloid-cell-engager-enters-clinic

A new myeloid cell engager enters the clinic | ApexOnco The mechanism of Gilead's GS-5319 is undisclosed, but its phase 1 study is in MTAP-deficient solid tumours, suggesting that this molecule is a ...

7. linkedin.com linkedin.com/posts/sreedhar-reddy-b0a7784_oncology-clinicaltrials-clin-activity-7376161202617573377-5aQO

Landscapes: A tool for navigating complex oncology trials ... ... GS-US-707-7297 study. This Phase 1 trial is designed to evaluate the safety and tolerability of GS-5319, a first-in-class therapy targeting ...