Study of BMS-986466 with Adagrasib with or without Cetuximab in Participants with KRAS G12C-mutant Solid Tumors

Phase 1

• Conditions: Oncology, NSCLC and CRC; Therapeutic area: Diseases [C] - Neoplasms [C04]; MedDRA version: 22.0Level: LLTClassification code: 10069759Term: KRAS mutation Class: 10018065

• Registration Number: CTIS2023-505070-15-00
• Lead Sponsor: Bristol-Myers Squibb Services Unlimited Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-20
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 399

Inclusion 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified