Clinical Trials in Spain / NCT07160725
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
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
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Other trials for the same condition
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