A Phase 1 Multiple Expansion Cohort Trial of MRTX1719 in Patients With Advanced Solid Tumors With Homozygous MTAP Deletion
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Enrollment
- 320
- Locations
- 22
- Primary Endpoint
- Number of Patients who Experience Dose-Limiting Toxicity
Study Overview
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 with homozygous deletion of the MTAP gene.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Phase 1/1B
Dose Escalation/Evaluation
Intervention: MRTX1719 (Drug)
Phase 1b Sub-Study
MRTX1719 in combination with standard of care therapy in selected solid tumor malignancies with MTAP homozygous deletion
Intervention: MRTX1719 (Drug)
Outcomes
Primary Outcomes
Number of Patients who Experience Dose-Limiting Toxicity
Time Frame: 21 days
Number of patients who experience a treatment-related adverse event
Time Frame: Up to 2 years
Objective response rate (ORR)
Time Frame: 2 years
Duration of response (DOR)
Time Frame: 2 years
Progression free survival (PFS)
Time Frame: 2 years
Overall survival (OS)
Time Frame: 2 years
Secondary Outcomes
- Area under the plasma concentration versus time curve (AUC)(Up to 4 days)
- Time to achieve maximal plasma concentration (Tmax)(Up to 4 days)
- Maximum observed plasma concentration (Cmax)(Up to 4 days)
- Terminal elimination half-life (t1/2)(Up to 4 days)
- Apparent total plasma clearance when dosed orally (CL/F)(Up to 4 days)
- Apparent volume of distribution when dosed orally (Vz/F)(Up to 4 days)