Evaluating a new treatment for advanced malignant tumors
A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
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 |
| Enrollment | 240 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 17 sites (Los Angeles, California and 16 other locations) |
| Trial ID | NCT06476808 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with leptomeningeal metastases or concurrent malignancies requiring treatment may not benefit from this study.
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 performed: While this approach is being evaluated in this specific context, similar studies have shown promise in targeting advanced malignant tumors with novel therapies.
Eligibility criteria
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 this trial is running
Los Angeles, California and 16 other locations
- 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)
- Local Institution - 0045 — Columbus, Ohio, United States (Not_yet_recruiting)
- Local Institution - 0046 — Dallas, Texas, United States (Not_yet_recruiting)
- Local Institution - 0049 — Houston, Texas, United States (Not_yet_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)
- Jewish General Hospital — Montreal, Quebec, Canada (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.