A Study of BMS-986463 for Advanced Malignant Tumors

This study is testing a new drug called BMS-986463 in people with certain advanced cancers, including high-grade serous ovarian carcinoma (HGSOC), uterine serous carcinoma (USC), and non-small cell lung cancer (NSCLC). The main goal is to see how safe BMS-986463 is and how well your body tolerates different doses. Researchers will also look at how effective the drug is. To join, you must be at least 18 years old, have a good general health status (ECOG 0 or 1), and have cancer that cannot be removed by surgery or has spread. You'll also need to have a tumor that can be biopsied. The study is currently recruiting participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. The planned enrollment is 240 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for up to 108 weeks (about 2 years) to track any side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06476808

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~240 participants
Updated 2026-07-20 on ClinicalTrials.gov
What's tested:BMS-986463

At a glance

Recruiting sites
7 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events (AEs)
Measured over Up to 108 weeks
+4 more outcomes measured
High-grade Serous Ovarian Carcinoma (HGSOC)
Uterine Serous Carcinoma (USC)
Non-small Cell Lung Cancer (NSCLC)
17 sites across 13 states
California2
Texas2
Quebec2
Italy2
New Jersey1
Ohio1
British Columbia1
Ontario1
  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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Eligibility criteria

Inclusion

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

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.
  • 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) criteriaUp to 108 weeks
  • Number of participants with AEs leading to discontinuationUp to 108 weeks
  • Number of participants with AEs leading to deathUp to 108 weeks