Clinical trial Recruiting at 7 sites Phase 1 Interventional Ages 18 and up

Evaluating a new treatment for advanced malignant tumors

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

Run by Bristol-Myers Squibb · NCT06476808 · Data updated 2026-11-12

This study is testing a new drug called BMS-986463 to see if it is safe and effective for people with advanced cancers like ovarian and lung cancer.

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment240 (estimated)
SponsorBristol-Myers Squibb
Industry-sponsored
Drugs / interventionsradiation
Locations17 sites (Los Angeles, California and 16 other locations)
StatusRecruiting
StartedSeptember 6, 2024
Main results expectedDecember 19, 2028
Study endsDecember 19, 2028
Registry record updatedJuly 20, 2026
Trial IDNCT06476808 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients with unresectable or metastatic high-grade serous ovarian carcinoma, uterine serous carcinoma, or non-small cell lung cancer who meet specific performance status and biopsy criteria.

Probably not a fit

Patients with leptomeningeal metastases or concurrent malignancies requiring treatment may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants diagnosed with select advanced malignant tumors, including high-grade serous ovarian carcinoma, uterine serous carcinoma, and non-small cell lung cancer. Participants will undergo treatment with BMS-986463, and their responses will be monitored to determine the drug's effectiveness and safety profile. The study will include patients with unresectable or metastatic carcinoma and will require biopsies to evaluate tumor characteristics.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced malignant tumors.

How similar studies have gone: While this approach is being evaluated in this specific context, similar studies have shown promise in targeting advanced malignant tumors with novel therapies.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California, United States
    Recruiting
  • Valkyrie Clinical Trials
    Los Angeles, California, United States
    Recruiting
  • John Theurer Cancer Center at Hackensack University Medical Center
    Hackensack, New Jersey, United States
    Recruiting
  • BC Cancer Vancouver
    Vancouver, British Columbia, Canada
    Recruiting
  • Princess Margaret Cancer Centre
    Toronto, Ontario, Canada
    Recruiting
  • Centre Hospitalier de l'Université de Montréal
    Montreal, Quebec, Canada
    Recruiting
Show 11 more locations
  • Jewish General Hospital
    Montreal, Quebec, Canada
    Recruiting
  • Local Institution - 0045
    Columbus, Ohio, United States
    Not yet recruiting
  • Local Institution - 0046
    Dallas, Texas, United States
    Withdrawn
  • Local Institution - 0049
    Houston, Texas, United States
    Not yet recruiting
  • Local Institution - 0036
    Bordeaux, Aquitaine, France
    Not yet recruiting
  • Local Institution - 0031
    Villejuif, Val-de-Marne, France
    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], Spain
    Not yet recruiting
  • Local Institution - 0041
    Avda.Pio XII 36,, Spain
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.