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BMS-986466 + Adagrasib for KRAS-Mutant Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For PDAC and BTC: Participants must have a documented KRAS G12Cmutation from NYS or FDA-approved/cleared, or CE-marked test and blood samples will be collected only for retrospective testing.
Individuals with a confirmed diagnosis of advanced KRAS G12C-mutant NSCLC (Part 2A) or CRC (Part 2B) that has spread to other parts of the body and cannot be removed surgically and have not received previous treatment with KRAS inhibitors.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 4 years
Awards & highlights

Study Summary

This trial tests a new drug combo to treat lung, pancreatic, biliary and colorectal cancers with a KRAS mutation.

Who is the study for?
This trial is for adults with advanced KRAS G12C-mutant solid tumors like lung, pancreatic, biliary tract, or colorectal cancer that's spread and can't be surgically removed. They should have tried at least one therapy before or not tolerated it. They mustn't have certain other mutations or heart conditions and should avoid specific medications.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of BMS-986466 taken orally in combination with adagrasib, with or without cetuximab. It aims to determine the best dose for treating various advanced cancers with a specific mutation (KRAS G12C).See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system due to cetuximab, liver issues from BMS-986466, and gastrointestinal symptoms from adagrasib. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has a specific KRAS G12C mutation.
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My advanced cancer has a KRAS G12C mutation and hasn't been treated with KRAS inhibitors.
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My lung or colon cancer has a specific KRAS G12C mutation.
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My condition worsened or returned after one treatment, or I couldn't tolerate the treatment.
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My condition did not improve after standard treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with dose limiting toxicity (DLTs)
Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Secondary outcome measures
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Disease Control Rate (DCR) assessed by BICR as per RECIST v1.1
Duration of Response (DOR) assessed by BICR as per RECIST v1.1
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment3 Interventions
Group II: Part 1: Dose EscalationExperimental Treatment3 Interventions
Group III: Part 1: DDI CohortExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adagrasib
2023
Completed Phase 1
~20
Cetuximab
2011
Completed Phase 3
~2480

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,638 Previous Clinical Trials
4,128,104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there multiple US-based sites hosting this trial?

"This clinical research is currently taking place at Valkyrie Clinical Trials in Los Angeles, California; University Cancer & Blood Center, LLC located in Athens, Georgia; John Theurer Cancer Center situated within Hackensack University Medical Centre of New jersey and 25 other medical centres."

Answered by AI

Is there currently an opportunity for participants to join this experimental study?

"The records on clinicaltrials.gov denote that this particular medical trial, first posted September 6th 2023, is not currently recruiting patients. However there are over two thousand and six hundred other trials actively enrolling participants as of now."

Answered by AI

Who else is applying?

What site did they apply to?
University of Alabama at Birmingham
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors
2023. "A Study of BMS-986466 With Adagrasib With or Without Cetuximab in Participants With Kirsten Rat Sarcoma Virus Glycine 12 to Cysteine (KRAS G12C)-Mutant Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06024174.
~0 spots leftby May 2024
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