Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Phase 1/2 Study of MRTX1719 in Solid Tumors With MTAP Deletion
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.
anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid
tumor malignancy with homozygous deletion of the MTAP gene.
Not Available
Phase I/II
Adults
Not Available
Not Available
Davis, Elizabeth
National
Vanderbilt University
05-28-2025
Eligibility
18 Years
BOTH
NO
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.
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
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.
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
