Solid Tumor Clinical Trial
Official title:
A Phase 1/2 Multiple Expansion Cohort Trial of the SOS1 Inhibitor MRTX0902 in Patients With Advanced Solid Tumors Harboring Mutations in the KRAS MAPK Pathway
This is a Phase 1/2, open-label, multicenter, study evaluating the safety, tolerability, PK, PD, and anti-tumor activity of MRTX0902 alone and in combination with MRTX849 (adagrasib) in patients with advanced solid tumor malignancy harboring mutations in the KRAS-MAPK pathways.
Status | Recruiting |
Enrollment | 228 |
Est. completion date | July 30, 2026 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Histologically confirmed diagnosis of a solid tumor malignancy with any of the following oncogenic mutations detected in tumor tissue or ctDNA by a sponsor-approved test: 1. MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation; 2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation. - Unresectable or metastatic disease - No available treatment with curative intent; standard treatment is not available or patient declines - Presence of tumor lesions to be evaluated per RECIST 1.1: 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. - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. - Adequate organ function Exclusion Criteria: - Active brain metastases or carcinomatous meningitis - Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination, and Phase 2 cohorts only) - 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 pneumonitis or interstitial lung disease - Ongoing need for medication with following characteristics: substrate of CYP3A; strong inducer or inhibitor or CYP3A and/or P-gp; strong inhibitors of BRCP and proton pump inhibitors - Cardiac abnormalities - 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 |
Country | Name | City | State |
---|---|---|---|
Puerto Rico | Pan American Center for Oncology Trials, LLC | Rio Piedras | |
United States | Johns Hopkins University | Baltimore | Maryland |
United States | University of Cincinnati Cancer Institute | Cincinnati | Ohio |
United States | NEXT Virginia - NEXT Oncology - PPDS | Fairfax | Virginia |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | Sarah Cannon Research Institute Central Office | Nashville | Tennessee |
United States | Tennessee Oncology NASH | Nashville | Tennessee |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Oregon Health and Science University | Portland | Oregon |
United States | Local Institution - 001-110 | Rochester | Minnesota |
United States | Seattle Cancer Care Alliance | Seattle | Washington |
United States | Local Institution - 001-113 | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Mirati Therapeutics Inc. |
United States, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Phase 1: Number of Patients who Experience Dose-Limiting Toxicity | 21 Days | ||
Primary | Phase1/1B: Number of patients who experience a treatment-related adverse event | Up to 2 years | ||
Primary | Phase 2: Objective response rate (ORR) | 2 years | ||
Primary | Phase 2: Duration of response (DOR) | 2 years | ||
Primary | Phase 2: Progression free survival (PFS) | 2 years | ||
Primary | Phase 2: Overall survival (OS) | 2 years | ||
Secondary | Area under the plasma concentration versus time curve | AUC - MRTX0902 and adagrasib | Up to 4 days | |
Secondary | Time to achieve maximal plasma concentration | Tmax - MRTX0902 and adagrasib | Up to 4 days | |
Secondary | Maximum observed plasma concentration | Cmax - MRTX0902 and adagrasib | Up to 4 days | |
Secondary | Terminal elimination half-life | t1/2 - MRTX0902 | Up to 4 days | |
Secondary | Apparent total plasma clearance when dosed orally | CL/F - MRTX0902 | Up to 4 days | |
Secondary | Apparent volume of distribution when dosed orally | Vz/F - MRTX0902 | Up to 4 days |
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