MRTX1719 for Solid Tumors

Recruiting at 22 trial locations

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Must not be taking: PRMT5, MAT2A inhibitors

Disqualifiers: Brain metastases, Hemorrhage, Cardiac abnormalities, others

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

Compensation: Varies

Number of Visits: Unknown

320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called MRTX1719, an experimental therapy, to determine its safety and effectiveness for individuals with advanced solid tumors that cannot be surgically removed. Researchers focus on tumors with a specific genetic change known as MTAP deletion. The trial consists of two parts: testing MRTX1719 alone and in combination with standard treatments. It suits those with this genetic change in their tumor who cannot undergo surgery. As a Phase 1 trial, the research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that MRTX1719 is likely to be safe for humans?

Research has shown that MRTX1719 has been tested for safety in patients with solid tumors, particularly those with a specific genetic change called MTAP deletion. Early results suggest that MRTX1719 is generally well-tolerated. Some patients in studies have experienced side effects, but these can vary and are often manageable.

As this treatment is in the early stages of human testing (Phase 1), the main goal is to assess its safety and determine the maximum tolerated dose. While some initial safety information is available, the complete safety profile is still being developed. Prospective trial participants should discuss any concerns with the research team. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about MRTX1719 because it targets solid tumors with a unique approach. Unlike standard treatments that often focus on inhibiting tumor growth through broad methods like chemotherapy, MRTX1719 is designed specifically for tumors with MTAP homozygous deletion. This targeted approach could result in more effective and personalized treatment outcomes. Additionally, MRTX1719 is used in combination with the standard of care, potentially enhancing the effectiveness of existing therapies and offering hope for improved survival rates in patients with these specific genetic tumor profiles.

What evidence suggests that MRTX1719 might be an effective treatment for solid tumors?

Research has shown that MRTX1719 may help treat solid tumors with a specific genetic change called MTAP deletion. This trial includes two arms: one focuses on dose escalation and evaluation, while the other combines MRTX1719 with standard care therapy. Studies have found that MRTX1719 can significantly shrink tumors, particularly in cancers such as lung, pancreatic, and mesothelioma. Early clinical data support these findings, with some patients experiencing noticeable tumor reduction. MRTX1719 targets an enzyme called PRMT5 to halt tumor growth. This focused approach offers hope for patients with these difficult-to-treat cancers. ^{1 3 4 5 6}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for adults with advanced solid tumors, like stomach cancer or lung cancer, that can't be removed by surgery and have a specific genetic change called MTAP deletion. Participants must be able to take oral medication and have measurable disease.

Inclusion Criteria

My tumor can be biopsied unless deemed unsafe.

My cancer cannot be removed by surgery or has spread.

I am fully active or can carry out light work.

Exclusion Criteria

I have heart problems.

I have been treated with a PRMT5 or MAT2A inhibitor before.

Other protocol-defined Inclusion/Exclusion criteria apply

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Exploration of MRTX1719 dose and regimen in patients with advanced solid tumors

8-12 weeks

Phase 1b Expansion

Implementation of expansion cohorts to gather safety, PK, and clinical activity data

12-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRTX1719

Trial Overview The study tests MRTX1719's safety and effectiveness in treating various cancers with the MTAP deletion. It's an early-stage (Phase 1) trial where everyone gets MRTX1719 to see how well it works and what doses are safe.

How Is the Trial Designed?

Group I: Phase 1b Sub-Study Experimental Treatment 1 Intervention

MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion

Group II: Phase 1/1B Experimental Treatment 1 Intervention

Dose Escalation/Evaluation

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05245500

NCT05245500 | Phase 1 Study of MRTX1719 in Solid ... This is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10618744/

MRTX1719 Is an MTA-Cooperative PRMT5 Inhibitor That ... MRTX1719 Demonstrates RECIST Responses in Patients with MTAP Del Cancer. MRTX1719 has been evaluated in patients with solid tumors harboring MTAP deletions ...

3. prnewswire.com prnewswire.com/news-releases/cancer-discovery-publishes-preclinical-and-initial-clinical-data-for-mrtx1719-to-treat-mtap-deleted-cancers-through-novel-approach-to-mta-cooperative-prmt5-inhibition-301897212.html

Cancer Discovery Publishes Preclinical and Initial Clinical ... Preclinical results showed marked anti-tumor activity of MRTX1719, including regression, across lung, pancreatic, mesothelioma, and other solid ...

4. mayo.edu mayo.edu/research/clinical-trials/cls-20542686

Phase 1/2 Study Of MRTX1719 In Solid Tumors With MTAP ... The purpose of this study is to to characterize the safety, tolerability, and pharmacokinetics of MRTX1719 in patients with advanced solid tumor malignancies.

5. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/cancer/clinicaltrial/2663/phase-12-multiple-expansion/

A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in ... This study is testing the effectiveness of a new drug, MRTX1719, in patients with advanced solid tumors that have a specific genetic change called MTAP ...

6. bmsclinicaltrials.com bmsclinicaltrials.com/us/en/clinical-trials/NCT05245500

Trial ID CA240-0007 | NCT05245500 - BMS Clinical Trials This is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unr