Recruiting

Trial ID CA247-0004 | NCT05578092

A Phase 1/2 Study of MRTX0902 in Solid Tumors With Mutations in the KRAS MAPK Pathway

About This Trial
Key Eligibility Criteria
Trial Site Locations

Summary

Phase 1/Phase 2
18+

Age Range
12

Locations
Recruiting

Overview

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.

Nearest Recruiting Site

Key Eligibility Criteria

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

Additional Information *

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Phase 1/1B Combination Therapy

ASSIGNED INTERVENTION

Drug: MRTX0902, MRTX849

Study Arms

Experimental: Phase 1/1B Monotherapy

ASSIGNED INTERVENTION

Drug: MRTX0902

Study Arms

Experimental: Phase 2

ASSIGNED INTERVENTION

Drug: MRTX0902, MRTX849

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Trial ID CA247-0004 | NCT05578092

Summary

Overview

Nearest Recruiting Site

Key Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Treatment Options

Study Arms

ASSIGNED INTERVENTION

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