Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion

  • End date
    Jan 31, 2024
  • participants needed
  • sponsor
    Mirati Therapeutics Inc.
Updated on 4 October 2022
measurable disease


This is a Phase 1/2, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.


This first-in-human clinical trial will begin with an exploration of MRTX1719 dose and regimen. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure sufficient safety experience, PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX1719.

Condition Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, Pancreatic Adenocarcinoma, Advanced Solid Tumor
Treatment MRTX1719
Clinical Study IdentifierNCT05245500
SponsorMirati Therapeutics Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue or ctDNA
Unresectable or metastatic disease
Patients must have received standard therapies appropriate for their tumor type and stage with disease progression on or after the most recent treatment
Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease
Presence of a tumor lesion amenable to mandatory biopsy for pharmacodynamic evaluation
at baseline and on-study unless Sponsor-confirmed as medically unsafe or
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function

Exclusion Criteria

Prior treatment with a PRMT5 or MAT2A inhibitor therapy (Phase 2 only)
Active brain metastases or carcinomatous meningitis
History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment
Major surgery within 4 weeks of first dose of study treatment
History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions (eg, uncontrolled nausea, vomiting, malabsorption syndrome) likely to alter absorption of study treatment or result in inability to swallow oral medications
Cardiac abnormalities
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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