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Recruiting Phase 1

A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.

NCT06476808 · tracked via the Priya Life Science France tracker
Phase
Phase 1
Started
2024-09-06
Last updated
2026-07-20

Condition(s) studied

High-grade Serous Ovarian Carcinoma (HGSOC)Uterine Serous Carcinoma (USC)Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

BMS-986463

BMS-986463: Specified dose on specified days

Study summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria * Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1. * Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained. * Participants must have an unresectable/metastatic carcinoma. Exclusion Criteria * Participants must not have Leptomeningeal metastases. * Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment. * Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment. * Other protocol-defined Inclusion/Exclusion criteria apply.

Primary outcome measure(s)

  • Number of participants with adverse events (AEs) — Up to 108 weeks
  • Number of participants with serious adverse events (SAEs) — Up to 108 weeks
  • Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria — Up to 108 weeks
  • Number of participants with AEs leading to discontinuation — Up to 108 weeks
  • Number of participants with AEs leading to death — Up to 108 weeks

Trial sites (17)

FacilityCityRegionStatus
USC/Norris Comprehensive Cancer Center Los Angeles California Recruiting
Valkyrie Clinical Trials Los Angeles California Recruiting
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey Recruiting
Local Institution - 0045 Columbus Ohio Not Yet Recruiting
Local Institution - 0046 Dallas Texas Withdrawn
Local Institution - 0049 Houston Texas Not Yet Recruiting
BC Cancer Vancouver Vancouver British Columbia Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Centre Hospitalier de l'Université de Montréal Montreal Quebec Recruiting
Jewish General Hospital Montreal Quebec Recruiting
Local Institution - 0036 Bordeaux Aquitaine Not Yet Recruiting
Local Institution - 0031 Villejuif Val-de-Marne Not Yet Recruiting
Local Institution - 0035 Lyon France Not Yet Recruiting
Local Institution - 0033 Milan Italy Not Yet Recruiting
Local Institution - 0032 Milan Italy Not Yet Recruiting
Local Institution - 0042 Barcelona Barcelona [Barcelona] Not Yet Recruiting
Local Institution - 0041 Avda.Pio XII 36, 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 NCT06476808 on ClinicalTrials.gov ↗ ← All trials in France