MRTX1719 for Solid Tumors

Recruiting at 38 trial locations

Overseen By First line of the email MUST contain the NCT# and Site #.

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

336 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 for individuals with advanced solid tumors that cannot be surgically removed or have metastasized. The focus is on tumors with a specific genetic change known as MTAP deletion. Researchers aim to assess the treatment's safety, patient tolerance, and its effectiveness in shrinking tumors. Candidates may qualify if they have a solid tumor with the MTAP gene deletion that is inoperable or has spread. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in humans.

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 shows that MRTX1719 is being tested for safety in patients with solid tumors that have a specific genetic change called MTAP deletion. This early-stage research examines how well patients tolerate the treatment and any side effects. Early results have shown some positive responses in patients with these tumors.

However, because this is an early-phase study, information about safety remains limited. This phase primarily aims to assess drug tolerance and identify possible side effects. Treatments at this stage often involve closely monitored testing to ensure patient safety. Prospective participants should discuss any concerns with the trial team to understand what to expect regarding safety and possible side effects. ^{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 new approach. Unlike standard treatments that might rely on chemotherapy or radiation, MRTX1719 specifically targets tumors with MTAP homozygous deletion. This precision focus aims to disrupt the tumor's survival mechanism directly, potentially leading to more effective outcomes with fewer side effects. By honing in on this specific genetic feature, MRTX1719 could offer a more personalized and efficient treatment option for patients with these particular tumor characteristics.

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

Research has shown that MRTX1719 may help treat solid tumors in people with MTAP gene deletions. In early studies, MRTX1719 shrank tumors in patients with these specific genetic changes. This treatment blocks PRMT5, a protein that cancer cells need to grow when the MTAP gene is missing. Lab studies also demonstrated that MRTX1719 could stop tumor growth in various cancers, such as lung and pancreatic cancer. This trial includes a Phase 1/1B arm for dose escalation and evaluation of MRTX1719, along with a Phase 1b Sub-Study arm where MRTX1719 is combined with standard care therapy in selected solid tumor malignancies. These findings suggest MRTX1719 might be effective against certain solid tumors, but further research is needed to confirm its benefits. ^{1 3 4 6 7}

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 that can't be surgically removed and have a specific genetic change called MTAP deletion. Participants must have tried standard treatments without success, be in fairly good health, and able to perform daily activities with ease or only slight difficulty.

Inclusion Criteria

My cancer has worsened despite receiving all standard treatments.

My cancer has a specific genetic change called MTAP deletion.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I have not had major surgery in the last 4 weeks.

I have heart problems.

I have active brain metastases or carcinomatous meningitis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation/Evaluation

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

8-12 weeks

Phase 1b Expansion

Implementation of expansion cohorts to ensure safety, PK information, and early evidence of clinical activity

12-16 weeks

Phase 2

Evaluation of clinical activity and efficacy of MRTX1719 in separate cohorts by histological diagnosis

16-24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MRTX1719

Trial Overview The study tests MRTX1719's safety and effectiveness against various solid tumors with the MTAP deletion. It's an early-stage trial (Phase 1/2), where researchers also look at how the body processes the drug and its impact on tumor size.

How Is the Trial Designed?

Group I: Phase 1b Sub-study 5 Experimental Treatment 1 Intervention

Group II: Phase 1b Sub-studies 1-4 Experimental Treatment 1 Intervention

Group III: 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

Mirati Therapeutics Inc.

Lead Sponsor

Trials

73

Recruited

8,900+

Dr. Charles M. Baum

Mirati Therapeutics Inc.

Chief Executive Officer since 2023

MD, PhD

Dr. Joseph Leveque

Mirati Therapeutics Inc.

Chief Medical Officer since 2021

MD

Citations

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

Phase 1 Study of MRTX1719 in Solid Tumors With MTAP ... 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. pubs.acs.org pubs.acs.org/doi/10.1021/acs.jmedchem.1c01900

MTA Complex for the Treatment of MTAP-Deleted Cancers These data demonstrate concentration- and target-dependent tumor growth inhibition by MRTX1719 in an MTAP-del xenograft efficacy model of lung cancer.

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

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06672523

NCT06672523 | A Study to Evaluate the Mass Balance, ... The purpose of this study is to evaluate the mass balance, metabolism, elimination, and drug levels of [14C]-BMS-986504 (MRTX1719) in participants with advanced ...