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

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.

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.

1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease

2. 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