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
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 240 (estimated) |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Status | Recruiting |
| Started | September 6, 2024 |
| Main results expected | December 19, 2028 |
| Study ends | December 19, 2028 |
| Registry record updated | July 20, 2026 |
| Trial ID | NCT06476808 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
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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
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.