Recruiting
Phase 2

Adagrasib

Sponsor:

Mirati Therapeutics Inc.

Code:

NCT07415031

Conditions

Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Adagrasib

Pembrolizumab

Cetuximab

Pemetrexed

Docetaxel

Study Details

Brief summary:

This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.

Conditions

Solid Tumors

Study ID

NCT07415031

Start date

May 6, 2026

Status verified date

Sep, 2026

Completion date

Feb 16, 2028

Anticipated

Primary completion date

Feb 16, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit.
  • Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.

Exclusion Criteria:

  • Participant is not eligible for study treatment per the parent study eligibility criteria.
  • Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study.
  • Participants not receiving clinical benefit from parent study drug as assessed by the investigator.

Other protocol defined inclusion/exclusion criteria applies.

Study Design

Enrollment

170 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A1

experimental: Arm A2

experimental: Arm B1

experimental: Arm B2

experimental: Arm B3

experimental: Arm B4

experimental: Arm C1

experimental: Arm C2

experimental: Arm C3

experimental: Arm C4

Interventions

Adagrasib

Specified dose on specified days

Pembrolizumab

Specified dose on specified days

Cetuximab

Specified dose on specified days

Pemetrexed

Specified dose on specified days

Docetaxel

Specified dose on specified days

Irinotecan

Specified dose on specified days

Leucovorin

Specified dose on specified days

Oxaliplatin

Specified dose on specified days

Fluorouracil

Specified dose on specified days

Primary outcome measure

  • Number of Participants With Adverse Events (AEs) [ Time Frame: Up to 90 days from last dose or study discontinuation ]
  • Number of Participants With AEs Leading to Treatment Discontinuation [ Time Frame: Up to 90 days from last dose or study discontinuation ]
  • Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 90 days from last dose or study discontinuation ]
  • Number of Participants With AEs Leading to Death [ Time Frame: Up to 90 days from last dose or study discontinuation ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Southern California Permanente Medical Group

Recruiting

Bellflower, California, United States, 90706

Contacts

Gary Buchschacher, Site 0016

000-000-0000

MemorialCare - Long Beach Medical Center

Recruiting

Long Beach, California, United States, 90806

Contacts

Nilesh Vora, Site 0082

562-997-4070

Florida Cancer Specialists - North

Recruiting

St. Petersburg, Florida, United States, 33701

Contacts

Maen Hussein, Site 0001

727-216-1143

Cancer Center of Kansas

Recruiting

Wichita, Kansas, United States, 67208

Contacts

Shaker Dakhil, Site 0112

316-262-4467

Dana Farber Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Pasi Janne, Site 0080

000-000-0000

Mayo Clinic in Rochester, Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Konstantinos Leventakos, Site 0017

507-284-2511

Metro-Minnesota Community Oncology Research Consortium (MMCORC)

Recruiting

Saint Paul, Minnesota, United States, 55101

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68114

Contacts

Mary Wells, Site 0036

531-329-3667

Oncology Associates Of Oregon, Pc

Recruiting

Eugene, Oregon, United States, 97401

Contacts

Jeff Porter Sharman, Site 0004

888-542-2525

The West Clinic, PLLC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38138

Contacts

Ramakrishna Battini, Site 0023

901-683-0055

Texas Oncology-Bedford

Recruiting

Bedford, Texas, United States, 76022

Contacts

Kartik Konduri, Site 0117

214-370-1000

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Kartik Konduri, Site 0118

214-370-1000

Texas Oncology - DFW

Recruiting

Grapevine, Texas, United States, 76051

Contacts

Kartik Konduri, Site 0002

214-370-1000

More Information

Sponsor

Mirati Therapeutics Inc.

Last update posted

Sep 22, 2026

Last verified

Sep, 2026

Keywords

  • Adagrasib
  • KRAS G12C
  • KRAS
  • NSCLC
  • CRC
  • Krazati

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-08. This information was provided to ClinicalTrials.gov by Mirati Therapeutics Inc. on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.