Clinical Trials in Spain / NCT06697197
Recruiting
Phase 1/2
A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
NCT06697197 · tracked via the Priya Life Science Spain tracker
Condition(s) studied
Advanced Solid Tumors
Investigational drug(s) / intervention(s)
BMS-986482Pumitamig →
BMS-986482: Specified dose on specified days
Pumitamig: Specified dose on specified days
Study summary
The purpose of this study is to investigate the safety and efficacy of BMS-986482 alone and as combination therapy in participants with advanced solid tumors.
Eligibility
Inclusion Criteria
* All participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy measurable by RECIST v1.1, and have received, be refractory to, ineligible for, intolerant of, or refused existing therapy(ies) known to provide clinical benefit for the condition of the participant.
* Participant must be ≥ 18 years or the legal age of consent in the jurisdiction in which the study is taking place, inclusive, at the time of signing the ICF.
Exclusion Criteria
* History of life threatening immune mediated toxicity related to prior T-cell agonist or checkpoint inhibitor therapy, except those that are unlikely to re-occur with standard countermeasures.
* Any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator.
* For participants in Part 1B1, 1B2, 2B1 and 2B2: active autoimmune disease or requirement for systemic immunosuppressive therapy.
* For participants in Part 1B1, 1B2, 2B1 and 2B2: History of interstitial lung disease or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
* For participants in Part 1B1, 1B2, 2B1 and 2B2: 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 (AEs) as assessed by National Cancer Institute -Common Terminology Criteria for Adverse Events version 5.0 (NCI-CTCAE v5.0) — Up to 135 days post last treatment visit
- Number of participants with Serious AEs (SAEs) as assessed by NCI-CTCAE v5.0 — Up to 135 days post last treatment visit
- Number of participants with AEs meeting protocol-defined Dose-Limiting Toxicity (DLT) criteria as assessed by NCI-CTCAE v5.0 — Up to Day 28
- Number of participants with AEs leading to discontinuation as assessed by NCI-CTCAE v5.0 — Up to 135 days post last treatment visit
- Number of deaths as assessed by NCI-CTCAE v5.0 — Through study completion (Up to 4 years)
Trial sites (21)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Irvine (UCI) Health - UC Irvine Medical Center | Irvine | California | Recruiting |
| The Angeles Clinic and Research Institute - West Los Angeles Office | Los Angeles | California | Recruiting |
| Local Institution - 0008 | Aurora | Colorado | Not Yet Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Northwell Health/ RJ Zuckerberg Cancer Center | Lake Success | New York | Recruiting |
| Levine Cancer Institute | Charlotte | North Carolina | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
| UZ Gent | Ghent | Oost-Vlaanderen | Recruiting |
| Rigshospitalet | Copenhagen | Capital Region | Recruiting |
| Assistance Publique Hôpitaux de Marseille - Hôpital de la Timone | Marseille | Bouches-du-Rhône | Recruiting |
| Gustave Roussy | Villejuif | Paris | Recruiting |
| General Hospital of Athens "Laiko" | Athens | Attikí | Recruiting |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | Thessaloníki | Recruiting |
| Fondazione IRCCS Istituto Nazionale dei Tumori | Milan | Lombardy | Recruiting |
| Istituto Clinico Humanitas | Rozzano | Milano | Recruiting |
| Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) | Amsterdam | North Holland | Recruiting |
| Erasmus Medisch Centrum | Rotterdam | Netherlands | Recruiting |
| Hospital Universitari Vall d'Hebron | Barcelona | Barcelona [Barcelona] | Recruiting |
| Clinica Universidad de Navarra | Pamplona | Navarre | Recruiting |
| Hospital Universitario HM Sanchinarro | Madrid | Spain | Recruiting |
| Karolinska Universitetssjukhuset Solna | Solna | Stockholms Län [se-01] | Recruiting |
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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 NCT06697197 on ClinicalTrials.gov ↗ ← All trials in Spain