A Phase 1/2a, open-label, dose-finding study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of combinations of BMS-986507 (BL-B01D1) in adult participants with advanced solid tumors.
Principal Investigator
Dott.ssa Vanesa Gregorc
Contact Information for Access
Phase
FASE I
Status
ATTIVO
Objective of the study
1. To evaluate the safety, tolerability, and dose for the development of BMS-986507 in combination with:
Group A - Osimertinib in patients with locally advanced or metastatic EGFR-mutated (EGFRmt) non-small cell lung cancer (NSCLC).
Group B - Pembrolizumab in patients with locally advanced or metastatic EGFR wild-type (EGFRwt) NSCLC.
Group C - Nivolumab in patients with locally advanced or metastatic triple-negative breast cancer (TNBC) or ER-low/HER2-negative breast cancer.
2. Determine the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of BMS-986507 in combination with:
Group B, Part 1: Dose Expansion - Pembrolizumab in patients with locally advanced or metastatic EGFRwt NSCLC.
Multiple Cancers:
Lung Cancer (EGFRmut)
Lung Cancer (EGFRwild-type)
TNBC
Breast Cancer (ER low/HER2-)
ClinicalTrials.gov ID NCT06618287
Sponsor: Bristol-Myers Squibb
https://clinicaltrials.gov/study/NCT06618287?term=CA2440001&rank=1
Pathologies
Breast Cancer , Lung Cancer
Medication
BMS-986507 (BL-B01D1: anti-HER3 and anti-EGFR antibody)
Osimertinib
Pembrolizumab
Who is eligible to participate in the study?
Patients who are 18 years of age or older and who meet the study’s eligibility criteria may participate in this study.
Patients with EGFR-mutated non-small cell lung cancer who have not received prior treatment.
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