Clinical trial NCT06618287: A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Lung Cancer
Keywords: Non-Small Cell Lung Cancer (NSCLC)
Epidermal Growth Factor Receptor mutated (EGFRmt)
Epidermal Growth Factor Receptor wild-type (EGFRwt)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 198
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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.

Exclusion Criteria

* Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
* Participants must not have spinal cord compression, symptomatic central nervous system (CNS) metastases. Progression of existing CNS metastases, or the appearance of new lesions as shown on CNS imaging during screening will be excluded. Participants with CNS metastases discovered during screening may be eligible.
* 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.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 3 years
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 3 years
measure: Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
timeFrame: Up to 3 years
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 3 years
measure: Number of participants with AEs leading to death
timeFrame: Up to 3 years
measure: Number of DLTs that occur during the DLT evaluation period
timeFrame: Up to 3 weeks
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to 3 years
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 3 years
measure: Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to 3 years
measure: Area under the serum concentration-time curve within a dosing interval (AUC(TAU))
timeFrame: Up to 3 years
measure: Objective response rate (ORR)
timeFrame: Up to 1 year
measure: Best Overall Response (BOR) as Assessed by RECIST v1.1
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0066
state: Alabama
city: Miami
country: United States
facility: Local Institution - 0009
state: Florida
city: Iowa City
country: United States
facility: Local Institution - 0065
state: Iowa
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Local Institution - 0052
state: Oregon
city: Pittsburgh
country: United States
facility: Local Institution - 0014
state: Pennsylvania
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Edmonton
country: Canada
facility: Local Institution - 0024
state: Alberta
city: Newmarket
country: Canada
facility: Local Institution - 0064
state: Ontario
city: Ottawa
country: Canada
facility: Local Institution - 0023
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0048
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0049
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0047
state: Región Metropolitana De Santiago
city: Bordeaux
country: France
facility: Local Institution - 0043
state: Aquitaine
city: Marseille
country: France
facility: Local Institution - 0045
state: Bouches-du-Rhône
city: Montpellier
country: France
facility: Local Institution - 0053
state: Hérault
city: Lyon
country: France
facility: Local Institution - 0050
state: Rhône-Alpes
city: Villejuif
country: France
facility: Local Institution - 0041
state: Val-de-Marne
city: Paris
country: France
facility: Local Institution - 0054
city: Paris
country: France
facility: Local Institution - 0040
city: Aviano
country: Italy
facility: Local Institution - 0034
state: Friuli-Venezia Giulia
city: Milan
country: Italy
facility: Local Institution - 0033
state: Lombardia
city: Candiolo
country: Italy
facility: Local Institution - 0056
state: Torino
city: Firenze
country: Italy
facility: Local Institution - 0035
state: Toscana
city: Roma
country: Italy
facility: Local Institution - 0032
city: Leiden
country: Netherlands
facility: Local Institution - 0004
state: Zuid-Holland
city: Amsterdam
country: Netherlands
facility: Local Institution - 0003
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0062
state: A Coruña [La Coruña]
city: Barcelona
country: Spain
facility: Local Institution - 0016
state: Barcelona [Barcelona]
city: Hospitalet
country: Spain
facility: Local Institution - 0058
state: Barcelona [Barcelona]
city: Barcelona
country: Spain
facility: Local Institution - 0059
state: Catalunya [Cataluña]
city: Madrid
country: Spain
facility: Local Institution - 0018
state: Madrid, Comunidad De
city: Majadahonda
country: Spain
facility: Local Institution - 0061
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Local Institution - 0017
city: Madrid
country: Spain
facility: Local Institution - 0019
city: Málaga
country: Spain
facility: Local Institution - 0063
city: València
country: Spain
facility: Local Institution - 0060
city: Birmingham
country: United Kingdom
facility: Local Institution - 0020
state: England
city: London
country: United Kingdom
facility: Local Institution - 0030
state: England
city: Glasgow
country: United Kingdom
facility: Local Institution - 0021
state: Glasgow City
city: Newcastle upon Tyne
country: United Kingdom
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: