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Recruiting Phase 1/2 NCT06618287

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors

Phase 1/2 – combined early trial
Conditions: Lung Cancer Breast Cancer

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary efficacy of BMS-986507 combinations in adult participants with advanced solid tumors.
Who can participate
Inclusion Criteria * Participants must have at least one measurable lesion per response evaluation criteria in solid tumors. * Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Participants must have a life expectancy of at least 3 months at the time of the first dose. * Group A: Participants must have pathologically confirmed locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation in exon 21, either alone or in combination with other EGFR mutations, which may include T790M in exon 20. Participants with other EGFR mutations (including but not limited to, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations, etc.) will also be allowed * Group B: Participants must have pathologically confirmed locally advanced or metastatic NSCLC. * Group C: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC or ER-low, HER2-negative BC. * Group D: Participants must have pathologically confirmed locally-advanced, recurrent inoperable, or metastatic TNBC per ASCO/CAP criteria, based on the most recently analyzed biopsy or another pathology specimen. * Group E: Participants must have pathologically confirmed locally advanced or metastatic NSCLC, not amenable to treatment in curative intent. Exclusion Criteria * Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology. * Participants with known mutations in EGFR will be excluded (Group A,B and E). * Participants must not have a history of serious recurrent infections. * Participants must not have a history of severe heart disease. * Other protocol-defined Inclusion/Exclusion criteria apply.
Locations 9
Australia (1)
Liverpool Hospital
Liverpool , New South Wales
Abhijit Pal, Site 0027
Canada (1)
Cross Cancer Institute
Edmonton , Alberta
Quincy Chu, Site 0024
Chile (1)
Local Institution - 0105
Valdivia , Los Ríos Region
NOT_YET_RECRUITING
France (1)
Local Institution - 0077
Nice , Alpes-Maritimes
WITHDRAWN
Italy (1)
Cro-Irccs
Aviano , Friuli Venezia Giulia
Alessandra Bearz, Site 0034
Netherlands (1)
Leids Universitair Medisch Centrum
Leiden , South Holland
Egbert Smit, Site 0004
Spain (1)
CHUS - Hospital Clinico Universitario
Santiago de Compostela , A Coruña [La Coruña]
United Kingdom (1)
Royal Free Hospital
London , England
Alexa Childs, Site 0030
United States (1)
University of Alabama at Birmingham
Birmingham , Alabama
Aakash Desai, Site 0066
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.02.2025
Completion date
26.02.2031
Registry ID
NCT06618287
Source
anzctr
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