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

Status: Recruiting
Location: See all (48) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alabama
Local Institution - 0066
NOT_YET_RECRUITING
Birmingham
Florida
University of Miami Hospital and Clinics, Sylvester Cancer Center
RECRUITING
Miami
Iowa
Local Institution - 0065
NOT_YET_RECRUITING
Iowa City
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Oregon
Local Institution - 0052
NOT_YET_RECRUITING
Portland
Pennsylvania
Local Institution - 0014
WITHDRAWN
Pittsburgh
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Australia
Liverpool Hospital
RECRUITING
Liverpool
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Canada
Cross Cancer Institute
RECRUITING
Edmonton
Centre Hospitalier de l'Université de Montréal
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Local Institution - 0064
NOT_YET_RECRUITING
Newmarket
Local Institution - 0023
WITHDRAWN
Ottawa
The Ottawa Hospital - General Campus
RECRUITING
Ottawa
Chile
Local Institution - 0047
NOT_YET_RECRUITING
Santiago
Local Institution - 0048
NOT_YET_RECRUITING
Santiago
Local Institution - 0049
NOT_YET_RECRUITING
Santiago
France
Local Institution - 0043
NOT_YET_RECRUITING
Bordeaux
Local Institution - 0050
NOT_YET_RECRUITING
Lyon
Local Institution - 0045
NOT_YET_RECRUITING
Marseille
Local Institution - 0053
NOT_YET_RECRUITING
Montpellier
Local Institution - 0077
NOT_YET_RECRUITING
Nice
Local Institution - 0040
NOT_YET_RECRUITING
Paris
Local Institution - 0054
NOT_YET_RECRUITING
Paris
Local Institution - 0041
NOT_YET_RECRUITING
Villejuif
Italy
Local Institution - 0034
NOT_YET_RECRUITING
Aviano
Local Institution - 0056
NOT_YET_RECRUITING
Candiolo
Local Institution - 0035
NOT_YET_RECRUITING
Florence
Local Institution - 0033
NOT_YET_RECRUITING
Milan
Local Institution - 0032
NOT_YET_RECRUITING
Roma
Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL)
RECRUITING
Amsterdam
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Spain
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Local Institution - 0059
WITHDRAWN
Barcelona
Local Institution - 0058
NOT_YET_RECRUITING
Hospitalet
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Local Institution - 0061
NOT_YET_RECRUITING
Majadahonda
H.R.U Málaga - Hospital General
RECRUITING
Málaga
Local Institution - 0062
NOT_YET_RECRUITING
Santiago De Compostela
Local Institution - 0060
NOT_YET_RECRUITING
Valencia
United Kingdom
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Local Institution - 0021
NOT_YET_RECRUITING
Glasgow
Royal Free Hospital
RECRUITING
London
Local Institution - 0001
NOT_YET_RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
BMS Study Connect www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site#
Time Frame
Start Date: 2025-02-04
Estimated Completion Date: 2028-08-24
Participants
Target number of participants: 238
Treatments
Experimental: Group A
Experimental: Group B
Experimental: Group C
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov