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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05578092
Other study ID # CA247-0004
Secondary ID CA247-00040902-0
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date November 4, 2022
Est. completion date July 30, 2026

Study information

Verified date June 2024
Source Mirati Therapeutics Inc.
Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Phone 855-907-3286
Email Clinical.Trials@bms.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

This first-in-human clinical trial will begin with an exploration of MRTX0902 dose and regimen. Once safety experience and PK data are available for the monotherapy regimen, dose escalation of the combination of MRTX0902 and adagrasib will be initiated, and will include a separate preliminary food effect assessments on MRTX0902 PK in combination with adagrasib. As potentially viable regimens are identified, Phase 1b expansion cohorts may be implemented to ensure collection of sufficient safety and PK information, and early evidence of clinical activity are available to recommend Phase 2 regimens. In Phase 2, separate cohorts of patients by histological diagnosis and/or baseline characteristics will be evaluated for the clinical activity and efficacy of MRTX0902 in combination with adagrasib.


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
MRTX0902
SOS1 inhibitor
MRTX849
KRAS G12C inhibitor

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

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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