Lung Cancer, Breast Cancer
Conditions
Keywords
Non-Small Cell Lung Cancer (NSCLC), Epidermal Growth Factor Receptor mutated (EGFRmt), Epidermal Growth Factor Receptor wild-type (EGFRwt), Triple-negative breast cancer (TNBC)
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.
Interventions
DRUGBMS-986507
Specified dose on specified days
DRUGOsimertinib
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
DRUGNivolumab
Specified dose on specified days
DRUGPumitamig
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with serious adverse events (SAEs) | Up to 3 years |
| Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera | Up to 3 years |
| Number of participants with AEs leading to discontinuation | Up to 3 years |
| Number of participants with AEs leading to death | Up to 3 years |
| Number of DLTs that occur during the DLT evaluation period | Up to 3 weeks |
| Number of participants with adverse events (AEs) | Up to 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) | Up to 3 years |
| Area under the serum concentration-time curve within a dosing interval (AUC(TAU)) | Up to 3 years |
| Objective response rate (ORR) | Up to 2 year |
| Maximum observed serum concentration (Cmax) | Up to 3 years |
| Time of maximum observed concentration (Tmax) | Up to 3 years |
Countries
Australia, Canada, Chile, France, Italy, Netherlands, Spain, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed