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

NCT05578092 | Terminated Phase 1 DMC FDA Drug

• 2 other identifiers: CA247-00040902-001
• Study Type: interventional
• Target: 64
• Locations: 2 countries
• Sites: 18

Brief Summary

This is a Phase 1, 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.

Conditions

Solid Tumor; Advanced Solid Tumor; Non Small Cell Lung Cancer; Colo-rectal Cancer

Keywords

Non Small Cell Lung Cancer; NSCLC; Colorectal Cancer; CRC; EGFR; KRAS; SOS1; Solid Tumor; Advanced Solid Tumor; Malignant

Outcome Measures

Primary Outcomes (2)

• Number of Patients who Experience Dose-Limiting Toxicity

  21 Days

• Number of patients who experience a treatment-related adverse event

  Up to 2 years

Secondary Outcomes (6)

• Area under the plasma concentration versus time curve

  Up to 4 days

• Time to achieve maximal plasma concentration

  Up to 4 days

• Maximum observed plasma concentration

  Up to 4 days

• Terminal elimination half-life

  Up to 4 days

• Apparent total plasma clearance when dosed orally

  Up to 4 days

Study Arms (2)

Phase 1/1B Monotherapy

EXPERIMENTAL

Dose Escalation/Evaluation

Drug: MRTX0902

Phase 1/1B Combination Therapy

EXPERIMENTAL

Dose Escalation/Evaluation and Food Effect Assessment

Drug: MRTX0902; Drug: MRTX849

Interventions

MRTX0902 DRUG

SOS1 inhibitor

Phase 1/1B Combination Therapy; Phase 1/1B Monotherapy

MRTX849 DRUG

KRAS G12C inhibitor

Also known as: adagrasib (KRAZATI)

Phase 1/1B Combination Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• MRTX0902 monotherapy: known KRAS mutations, known annotated recurrent activating SOS1, PTPN11, class III BRAF, or EGFR mutation, or known annotated recurrent inactivating NF1 mutation;
• 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. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable 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

You may not qualify if:

• Active brain metastases or carcinomatous meningitis
• Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination).
• 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

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (18)

Local Institution - 001-108

New Haven, Connecticut, 06520, United States

Location

Local Institution - 001-119

Newark, Delaware, 19713-2055, United States

Location

Local Institution - 001-111

Orlando, Florida, 32827-7400, United States

Location

Local Institution - 001-103

Baltimore, Maryland, 21287, United States

Location

Local Institution - 001-110

Rochester, Minnesota, 55905-0001, United States

Location

Local Institution - 001-115

Hackensack, New Jersey, 07601-2191, United States

Location

Local Institution - 001-106

Cincinnati, Ohio, 45219-2364, United States

Location

Local Institution - 001-109

Portland, Oregon, 97239-3011, United States

Location

Local Institution - 001-116

Pittsburgh, Pennsylvania, 15232, United States

Location

Local Institution - 001-101

Nashville, Tennessee, 37203, United States

Location

Local Institution - 001-102

Nashville, Tennessee, 37203, United States

Location

Local Institution - 001-112

Dallas, Texas, 75246-2003, United States

Location

Local Institution - 001-122

Fort Worth, Texas, 76104-2154, United States

Location

Local Institution - 001-107

Houston, Texas, 77030, United States

Location

Local Institution - 001-123

Tyler, Texas, 75708-3154, United States

Location

Local Institution - 001-104

Fairfax, Virginia, 22031, United States

Location

Local Institution - 001-105

Seattle, Washington, 98109, United States

Location

Local Institution - 001-114

Rio Piedras, 00935, Puerto Rico

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colonic Neoplasms; Colorectal Neoplasms

Interventions

adagrasib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2022
• First Posted: October 13, 2022
• Study Start: December 2, 2022
• Primary Completion: February 3, 2026
• Study Completion: February 3, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

PR (1); US (17)