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Recruiting Phase 1/2

A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

NCT07160725 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1/2
Started
2025-10-15
Last updated
2026-08-11

Condition(s) studied

Solid Tumours

Investigational drug(s) / intervention(s)

BMS-986517Pumitamig →

BMS-986517: Specified dose on specified days

Pumitamig: Specified dose on specified days

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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/Exclusion criteria apply.

Primary outcome measure(s)

  • 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

Trial sites (20)

FacilityCityRegionStatus
Local Institution - 0033 Irvine California Not Yet Recruiting
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
University of California, Irvine (UCI) Health - UC Irvine Medical Center Orange California Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
Sanford Cancer Center Sioux Falls South Dakota Recruiting
START - Dallas Fort Worth Fort Worth Texas Recruiting
START San Antonio San Antonio Texas Recruiting
START Mountain Region West Valley City Utah Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
Local Institution - 0034 Guangzhou Guangdong Not Yet Recruiting
Herlev and Gentofte Hospital Copenhagen Capital Region Recruiting
Odense Universitetshospital Odense Region Syddanmark Recruiting
Copenhagen University Hospital Rigshospitalet Copenhagen Denmark Recruiting
National Cancer Center Hospital Chuo-ku Tokyo Recruiting
Local Institution - 0026 Málaga Andalusia Not Yet Recruiting
Local Institution - 0022 Badalona Barcelona [Barcelona] Not Yet Recruiting
Local Institution - 0024 Barcelona Barcelona [Barcelona] Not Yet Recruiting
Clinica Universidad de Navarra Pamplona Navarre Recruiting
Hospital Universitario Fundación Jiménez Díaz Madrid Spain Recruiting
Local Institution - 0023 Madrid Spain Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07160725 on ClinicalTrials.gov ↗ ← All trials in Spain