Solid Tumours
Conditions
Brief summary
A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors
Interventions
DRUGBMS-986517
Specified dose on specified days
DRUGPumitamig
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have an ECOG performance status of 0 to 1. * Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator). * Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.
Exclusion criteria
* Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment). * Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment. * Participants must not have history of serious recurrent infections. * Participants must not have impaired cardiac function or history of severe heart disease. * For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy. * For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis. * For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AE) | Up to approximately 2 years | — |
| Number of Participants with Serious Adverse Events (SAE) | Up to approximately 2 years | — |
| Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria | Up to Day 21 | For part 1 only |
| Number of Participants with AEs Leading to Discontinuation | Up to approximately 2 years | — |
| Number of Participants with AEs Leading to Deaths | Up to approximately 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment | Up to approximately 3 years |
| Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment | Up to approximately 3 years |
| Maximum Plasma Concentration (Cmax) | Up to approximately 2 years |
| Time to Reach Maximum Plasma Concentration (Tmax) | Up to approximately 2 years |
| Area Under Curve (AUC) | Up to approximately 2 years |
| Total anti-drug antibodies (ADAs) | Up to approximately 2 Years |
Countries
China, Denmark, Japan, Spain, 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