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Study of BMS-986466 with Adagrasib with or without Cetuximab in Participants with KRAS G12C-mutant Solid Tumors
EU CTIS ID: 2023-505070-15-00
What this study is testing
1.To determine if the study treatment is safe and well-tolerated by the patients; to find the safe Maximum Tolerated Dose (MTD). If MTD is not reached the study will determine the Maximum Administered Dose (MAD). The study will identify dose levels for further testing: in Part 1A, BMS-986466 will be given with adagrasib to patients with advanced KRAS G12C mutant NSCLC, CRC, Pancreatic Duct Adenocarcinoma (PDAC), and Biliary Tract Cancer (BTC). In Part 1B, BMS-986466 will be given with adagrasib and cetuximab to participants with advanced KRAS G12C mutant CRC. 2.To determine if the study treatment is effective against cancer: - Part 2A: BMS-986466 given with adagrasib versus adagrasib alone in KRAS G12C mutant NSCLC naive to treatment with KRAS G12C inhibitor (G12Ci naive) -Part 2B: BMS-986466 given with adagrasib with or without cetuximab versus adagrasib plus cetuximab in KRAS G12C mutant, G12Ci naive CRC.
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Part 1: Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC and BTC that has spread to other parts of the body and cannot be removed surgically, may or may not have received previous treatment with KRAS G12C inhibitors.
- Part 1: For NSCLC and CRC: Participants must have a documented KRAS G12C mutation from an approved test and when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory at the time of screening.
- Part 1: For PDAC and BTC: Participants must have a documented KRAS G12C mutation from an approved test.
- Part 1: Have failed, are intolerant or recurrence after available standard of care treatments.
- Part 2: Individuals must have 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 are G12C inhibitors naive.
- Part 2: Participants must have a documented KRAS G12C mutation from an approved test and when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory at the time of screening.
You likely can't join if
- Have tumors with known BRAF V600X, PTPN11 or KRAS Q61X mutations.
- Have or any significant heart disease or condition.
- Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors.
See the full eligibility criteria
- Part 1: Individuals with a confirmed diagnosis of advanced KRAS G12C mutant NSCLC, CRC, PDAC and BTC that has spread to other parts of the body and cannot be removed surgically, may or may not have received previous treatment with KRAS G12C inhibitors.
- Part 1: For NSCLC and CRC: Participants must have a documented KRAS G12C mutation from an approved test and when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory at the time of screening.
- Part 1: For PDAC and BTC: Participants must have a documented KRAS G12C mutation from an approved test.
- Part 1: Have failed, are intolerant or recurrence after available standard of care treatments.
- Part 2: Individuals must have 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 are G12C inhibitors naive.
- Part 2: Participants must have a documented KRAS G12C mutation from an approved test and when such result is not available, positive KRAS G12C mutation status should be confirmed by a central laboratory at the time of screening.
- Part 2: Have failed, are intolerant or recurrence after at least 1 previous line of therapy.
- Have tumors with known BRAF V600X, PTPN11 or KRAS Q61X mutations.
- Have or any significant heart disease or condition.
- Receiving any medications that are substrate of CYP3A4 or inducers and/ or inhibitors.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- Israel
- United States
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; Israel; United States; Argentina. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.