CA2440001 - Phase 1/2a Study of BMS-986507 in Advanced Solid Tumours
Research type
Research Study
Full title
A Phase 1/2a, Open-label, Dose-finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BMS-986507 (BL-B01D1) combinations in Adult Participants with Advanced Solid Tumors
IRAS ID
1010861
Contact name
GSMCT Represenative
Contact email
Sponsor organisation
Bristol-Myers Squibb Services Unlimited Company
Eudract number
2024-514947-27
ISRCTN Number
none
Clinicaltrials.gov Identifier
Research summary
CA2440001 is a study looking at a new drug called BMS-986507 to see if it is safe and works well when used with standard treatments for advanced lung cancer. BMS-986507 is a new type of drug that targets specific proteins (EGFR and HER3) that may help lung cancer cells grow.
The study will have two groups of participants: one with a specific type of lung cancer that has EGFR mutations (Group A) and one without these mutations (Group B). Group A will receive BMS-986507 with a drug called Osimertinib, and Group B will receive BMS-986507 with another drug called pembrolizumab. The aim of the study is to find the best dose for further studies, check for side effects, and see initially, how well the drug works with other standard of care treatments. Osimertinib is an approved drug for the treatment of patients with advanced lung cancer with mutations in the EGFR gene. Pembrolizumab is also approved for the treatment of advanced lung cancer. This is an open label study which means participants and their doctor will know what treatment they are receiving.
Participants must be over 18 years old and have advanced NSCLC and meet certain criteria, such as having measurable tumours and being in good health. People with mixed types of cancer, certain genetic changes, untreated brain cancer, severe lung disease, or a history of serious infections cannot join the study.The study has three parts: screening, treatment, and follow-up. Treatment will last up to three years for Group A and two years for Group B, with regular check-ups to monitor safety and survival.
About 218 participants will join the study at various locations. The study is funded by Bristol-Myers Squibb and aims to find new treatment options for advanced lung cancer.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
25/NE/0017
Date of REC Opinion
27 Feb 2025
REC opinion
Further Information Favourable Opinion