Status:
RECRUITING
Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Mesothelioma
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a Phase 1, 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 wit...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed diagnosis of a solid tumor malignancy with homozygous deletion of the MTAP gene detected in tumor tissue.
- Unresectable or metastatic 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.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Exclusion
Key Trial Info
Start Date :
June 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 10 2027
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT05245500
Start Date
June 9 2022
End Date
December 10 2027
Last Update
December 5 2025
Active Locations (25)
Enter a location and click search to find clinical trials sorted by distance.
1
Mayo Clinic
Phoenix, Arizona, United States, 85054-4502
2
Sarah Cannon Research Institute (SCRI) - HealthONE Location
Denver, Colorado, United States, 80218-1238
3
Rocky Mountain Cancer Centers, LLP - Oncology
Lone Tree, Colorado, United States, 80124
4
Mayo Clinic
Jacksonville, Florida, United States, 32224