What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy agents like cisplatin and paclitaxel can cause nausea, vomiting, hair loss, and increased infection risk. Targeted therapies, such as EGFR inhibitors (e.g., osimertinib) and ALK inhibitors (e.g., crizotinib), may result in rash, diarrhea, and liver function abnormalities. Immunotherapies, including pembrolizumab and nivolumab, are associated with immune-related adverse events like pneumonitis, colitis, and thyroid dysfunction.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of Non-Small Cell Lung Cancer (NSCLC). For instance, RET inhibitors such as selpercatinib and pralsetinib are approved for RET fusion-positive NSCLC. These agents have shown significant efficacy in clinical trials, with high response rates and durable responses. Additionally, immune checkpoint inhibitors like pembrolizumab have been approved for PD-L1 positive NSCLC, either as monotherapy or in combination with chemotherapy. While specific FDA approvals for MTAP-deleted tumors are not mentioned, the ongoing study of MRTX1719 represents a promising area of research in targeted therapy for NSCLC.

What other types of research exist?

Promising novel alternatives to MRTX1719 for NSCLC patients include MDM2 inhibitors, such as milademetan, which have shown potential in targeting tumors with wild-type TP53 and receptor tyrosine kinase genes. Additionally, therapies identified through genome-wide CRISPR/Cas9 screening, which target specific genetic vulnerabilities in NSCLC, may also be considered.

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Anti-metabolites

MRTX1719 for Solid Tumors

Phase 1 & 2

Recruiting

Research Sponsored by Mirati Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment

Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue or ctDNA

Must not have

Major surgery within 4 weeks of first dose of study treatment

Cardiac abnormalities

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug, MRTX1719, for patients with advanced cancers that have a specific genetic deletion. The drug aims to kill cancer cells by exploiting a weakness caused by this genetic change.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects aren't specified here but may include typical reactions to cancer drugs such as nausea, fatigue, risk of infection, blood count changes, or other organ-related issues based on similar trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened despite receiving all standard treatments.

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My cancer has a specific genetic change called MTAP deletion.

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

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My cancer cannot be removed by surgery or has spread to other parts of my body.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have heart problems.

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I have active brain metastases or carcinomatous meningitis.

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

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I have a history of serious gut issues that could affect medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

3Treatment groups

Experimental Treatment

Group I: Phase 2Experimental Treatment1 Intervention

MRTX1719 RP2D administered to separate cohorts of patients with selected solid tumor malignancies with MTAP homozygous deletion to include the following: Mesothelioma, Pancreatic Adenocarcinoma, NSCLC, Malignant Peripheral Nerve Sheath Tumor, Other Solid Tumors

Group II: Phase 1b Sub-StudyExperimental Treatment1 Intervention

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

Group III: Phase 1/1BExperimental Treatment1 Intervention

Dose Escalation/Evaluation

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Non-Small Cell Lung Cancer (NSCLC) include targeted therapies, immunotherapies, and traditional chemotherapies. Targeted therapies, such as those inhibiting EGFR or ALK, work by blocking specific molecules involved in cancer cell growth and survival, making them effective for tumors with certain genetic mutations. Immunotherapies, like PD-1/PD-L1 inhibitors, enhance the body's immune response against cancer cells. Traditional chemotherapies, such as cisplatin and etoposide, kill rapidly dividing cells, including cancer cells. For NSCLC patients, these treatments are crucial as they offer personalized and effective options based on the tumor's genetic profile, improving outcomes and potentially reducing side effects. The trial MRTX1719, which targets MTAP-deleted tumors, represents a novel approach in this context, aiming to exploit specific genetic vulnerabilities in cancer cells for more precise and effective treatment.

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Who is running the clinical trial?

Mirati Therapeutics Inc.Lead Sponsor

70 Previous Clinical Trials

7,549 Total Patients Enrolled

Bristol-Myers Squibb, MDStudy DirectorBristol-Myers Squibb

2 Previous Clinical Trials

1,078 Total Patients Enrolled

Ron Schazer, MDStudy DirectorMirati Therapeutics Inc.

Media Library

MRTX1719 (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05245500 — Phase 1 & 2

Non-Small Cell Lung Cancer Research Study Groups: Phase 1b Sub-Study, Phase 1/1B, Phase 2

Non-Small Cell Lung Cancer Clinical Trial 2023: MRTX1719 Highlights & Side Effects. Trial Name: NCT05245500 — Phase 1 & 2

MRTX1719 (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245500 — Phase 1 & 2

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