ACTIVE_NOT_RECRUITING

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

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Conditions

Solid TumorAdvanced Solid TumorNon Small Cell Lung CancerColo-rectal CancerNSCLCColorectal CancerCRCEGFRKRASSOS1Malignant

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-12-02
Study Completion:2026-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05578092

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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:
  2. 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;
  3. 2. MRTX0902 and adagrasib combination therapy: KRAS G12C mutation.
  4. * Unresectable or metastatic disease
  5. * No available treatment with curative intent; standard treatment is not available or patient declines
  6. * Presence of tumor lesions to be evaluated per RECIST 1.1:
  7. 1. Phase 1 dose escalation, RECIST 1.1 measurable or evaluable disease
  8. 2. Phase 1b and Phase 2 cohorts, RECIST 1.1 measurable disease
  9. * 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.
  10. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  11. * Adequate organ function
  1. * Active brain metastases or carcinomatous meningitis
  2. * Prior treatment with a KRAS G12C inhibitor (for Phase 1b expansion for MRTX0902 and adagrasib combination, and Phase 2 cohorts only)
  3. * History of significant hemoptysis or hemorrhage within 4 weeks of the first dose of study treatment.
  4. * Major surgery within 4 weeks of first dose of study treatment
  5. * History of pneumonitis or interstitial lung disease
  6. * 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
  7. * Cardiac abnormalities
  8. * 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

Contacts and Locations

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 001-108
New Haven, Connecticut, 06520
United States
Local Institution - 001-119
Newark, Delaware, 19713-2055
United States
Local Institution - 001-111
Orlando, Florida, 32827-7400
United States
Local Institution - 001-103
Baltimore, Maryland, 21287
United States
Local Institution - 001-110
Rochester, Minnesota, 55905-0001
United States
Local Institution - 001-115
Hackensack, New Jersey, 07601-2191
United States
Local Institution - 001-106
Cincinnati, Ohio, 45219-2364
United States
Local Institution - 001-109
Portland, Oregon, 97239-3011
United States
Local Institution - 001-116
Pittsburgh, Pennsylvania, 15232
United States
Local Institution - 001-101
Nashville, Tennessee, 37203
United States
Local Institution - 001-102
Nashville, Tennessee, 37203
United States
Local Institution - 001-112
Dallas, Texas, 75246-2003
United States
Local Institution - 001-122
Fort Worth, Texas, 76104-2154
United States
Local Institution - 001-107
Houston, Texas, 77030
United States
Local Institution - 001-123
Tyler, Texas, 75708-3154
United States
Local Institution - 001-104
Fairfax, Virginia, 22031
United States
Local Institution - 001-105
Seattle, Washington, 98109
United States

Collaborators and Investigators

Sponsor: Mirati Therapeutics Inc.

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-02
Study Completion Date2026-07-30

Study Record Updates

Study Start Date2022-12-02
Study Completion Date2026-07-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

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