A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies

Sponsor: Mirati Therapeutics Inc.

Sponsor score: 40

ClinicalTrials ID:NCT07415031

This open-label trial continues treatment for participants from BMS parent studies on adagrasib, assessing its long-term effects in solid tumors. Eligible participants must show clinical benefit and adhere to contraception guidelines if applicable. Interventions include adagrasib, pembrolizumab, cetuximab, pemetrexed, docetaxel, irinotecan, leucovorin, oxaliplatin, and fluorouracil, administered in specified doses.

Patient Parameters

Program Overview

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.

Eligibility Criteria

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.

Locations

FACILITYZIPCITYSTATE
Local Institution - 000585054PhoenixArizona
Local Institution - 001690706BellflowerCalifornia
Local Institution - 008290806Long BeachCalifornia
Local Institution - 000319713NewarkDelaware
Local Institution - 000133701St. PetersburgFlorida
Local Institution - 006460637ChicagoIllinois
Local Institution - 011267208WichitaKansas
Local Institution - 009200215BostonMassachusetts
Local Institution - 008002215BostonMassachusetts
Mayo Clinic in Rochester, Minnesota55905RochesterMinnesota

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