A Phase 1/2 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With MTAP Homozygous Deletion

  • STATUS
    Recruiting
  • sponsor
    Mirati
Updated on 2 August 2022
measurable disease

Summary

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.

Description


Details
Condition Lung Cancer, Solid Tumors, Pancreatic Cancer
Clinical Study IdentifierTX295189
SponsorMirati
Last Modified on2 August 2022

Eligibility

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 infeasible
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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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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