Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors
About this trial
This is an interventional treatment trial for Mesothelioma focused on measuring MTAP Deletion, Mesothelioma, Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors, Solid Tumor, MTAP, Malignant, Pancreatic adenocarcinoma, Pancreas Cancer, PRMT5, Synthetic Lethality, Advanced Solid Tumor, NSCLC
Eligibility Criteria
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 โฅ 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
Sites / Locations
- Mayo ClinicRecruiting
- Sarah Cannon Research Institute at HealthONERecruiting
- Mayo ClinicRecruiting
- Sarah Cannon Research Institute at Florida Cancer SpecialistsRecruiting
- Dana Farber Cancer InstituteRecruiting
- Mayo ClinicRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- NorthShore Hematology Oncology Associates P.C New York Cancer and Blood SpecialistsRecruiting
- Sarah Cannon Research InstituteRecruiting
- MD Anderson Cancer CenterRecruiting
- Oncology Consultants, P.A.Recruiting
- START Center for Cancer CareRecruiting
- NEXT VirginiaRecruiting
- Froedtert Hospital & the Medical College of WisconsinRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Phase 1/1B
Phase 2
Dose Escalation/Evaluation
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