A Solid Tumor Study for Long Term Treatment of Cancer Patients Who Participated in Adagrasib Studies
ConditionSolid Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMirati Therapeutics Inc.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Adagrasib
DrugSpecified dose on specified days
Pembrolizumab
DrugSpecified dose on specified days
Cetuximab
DrugSpecified dose on specified days
Pemetrexed
DrugSpecified dose on specified days
Docetaxel
DrugSpecified dose on specified days
Irinotecan
DrugSpecified dose on specified days
Leucovorin
DrugSpecified dose on specified days
Oxaliplatin
DrugSpecified dose on specified days
Fluorouracil
DrugSpecified dose on specified days
Treatment groups
170 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Arm A1Experimental treatment 1 intervention
Group B: Arm A2Experimental treatment 1 intervention
Group C: Arm B1Experimental treatment 2 interventions
Group D: Arm B2Experimental treatment 2 interventions
Group E: Arm B3Experimental treatment 2 interventions
Group F: Arm B4Experimental treatment 3 interventions
Group G: Arm C1Experimental treatment 1 intervention
Group H: Arm C2Experimental treatment 1 intervention
Group I: Arm C3Experimental treatment 3 interventions
Group J: Arm C4Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Number of Participants With Adverse Events (AEs)
Time frame
Up to 90 days from last dose or study discontinuation2
Number of Participants With AEs Leading to Treatment Discontinuation
Time frame
Up to 90 days from last dose or study discontinuation3
Number of Participants With Serious Adverse Events (SAEs)
Time frame
Up to 90 days from last dose or study discontinuation4
Number of Participants With AEs Leading to Death
Time frame
Up to 90 days from last dose or study discontinuationSponsors and contacts
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Source ClinicalTrials.gov