Menu
Recruiting NCT06476808

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

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

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BMS-986463.
Who it may be relevant to
Registry conditions: High-grade Serous Ovarian Carcinoma (HGSOC), Uterine Serous Carcinoma (USC), Non-small Cell Lung Cancer (NSCLC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Canada, France, Italy, Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors

Overview

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.

Interventions

  • Drug BMS-986463
    Specified dose on specified days

Primary outcome measures

  • Number of participants with adverse events (AEs) [Time frame: Up to 108 weeks]
  • Number of participants with serious adverse events (SAEs) [Time frame: Up to 108 weeks]
  • Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria [Time frame: Up to 108 weeks]
  • Number of participants with AEs leading to discontinuation [Time frame: Up to 108 weeks]
  • Number of participants with AEs leading to death [Time frame: Up to 108 weeks]
Secondary outcome measures (6)
  • Maximum observed concentration (Cmax) [Time frame: Up to 104 weeks]
  • Area under the concentration-time curve (AUC) [Time frame: Up to 104 weeks]
  • Time of maximum observed concentration (Tmax) [Time frame: Up to 104 weeks]
  • Objective response rate (ORR) [Time frame: Up to 104 weeks]
  • Disease control rate (DCR) [Time frame: Up to 104 weeks]
  • Duration of response (DOR) [Time frame: Up to 104 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 6 centers
  • USC/Norris Comprehensive Cancer Center — Los Angeles
  • Valkyrie Clinical Trials — Los Angeles
  • John Theurer Cancer Center at Hackensack University Medical Center — Hackensack
  • Local Institution - 0045 — Columbus
  • Local Institution - 0046 — Dallas
  • Local Institution - 0049 — Houston
Canada · 4 centers
  • BC Cancer Vancouver — Vancouver
  • Princess Margaret Cancer Centre — Toronto
  • Centre Hospitalier de l'Université de Montréal — Montreal
  • Jewish General Hospital — Montreal
France · 3 centers
  • Local Institution - 0036 — Bordeaux
  • Local Institution - 0031 — Villejuif
  • Local Institution - 0035 — Lyon
Italy · 2 centers
  • Local Institution - 0033 — Milan
  • Local Institution - 0032 — Milan
Spain · 2 centers
  • Local Institution - 0042 — Barcelona
  • Local Institution - 0041 — Avda.Pio XII 36,

Identifiers

NCT: NCT06476808 · CA231-0000 · 2025-523067-38

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗