Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
Purpose
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 with homozygous deletion of the MTAP gene.
Conditions
- Mesothelioma
- Non Small Cell Lung Cancer
- Malignant Peripheral Nerve Sheath Tumors
- Solid Tumor
- Pancreatic Adenocarcinoma
- Advanced Solid Tumor
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Phase 1/1B |
Dose Escalation/Evaluation |
|
|
Experimental Phase 1b Sub-Study |
MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion |
|
Recruiting Locations
Vanderbilt - Ingram Cancer Center
Nashville 4644585, Tennessee 4662168 37232-5505
Nashville 4644585, Tennessee 4662168 37232-5505
Contact:
Elizabeth Davis, Site 132
206-341-1111
Elizabeth Davis, Site 132
206-341-1111
More Details
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com855-907-3286
Clinical.Trials@bms.com
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 sufficient safety experience, PK information, compare food effect and relative bioavailability between capsules and tablets, and early evidence of clinical activity are available.