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NCT Number: NCT06476808

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

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.

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Key information

Conditions

High-grade Serous Ovarian Carcinoma (HGSOC) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Non-small Cell Lung Cancer (NSCLC) Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Uterine Serous Carcinoma (USC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

BC Cancer Vancouver, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BMS-986463

Drug

Specified dose on specified days

Primary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 108 weeks

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 108 weeks

  3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

    Time frame: Up to 108 weeks

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 108 weeks

  5. Number of participants with AEs leading to death

    Time frame: Up to 108 weeks

Secondary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 104 weeks

  2. Area under the concentration-time curve (AUC)

    Time frame: Up to 104 weeks

  3. Time of maximum observed concentration (Tmax)

    Time frame: Up to 104 weeks

  4. Objective response rate (ORR)

    Time frame: Up to 104 weeks

  5. Disease control rate (DCR)

    Time frame: Up to 104 weeks

  6. Duration of response (DOR)

    Time frame: Up to 104 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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