RecruitingRecruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
NCT06476808 · Bristol-Myers Squibb
In plain English
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Official title
A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
About this study
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.
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.
Study design
Enrollment target: 240 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-06
Estimated completion: 2028-12-19
Last updated: 2026-07-20
Interventions
Drug: BMS-986463
Primary outcomes
- • Number of participants with adverse events (AEs) (Up to 108 weeks)
- • Number of participants with serious adverse events (SAEs) (Up to 108 weeks)
- • Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria (Up to 108 weeks)
Sponsor
Bristol-Myers Squibb · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (17)
USC/Norris Comprehensive Cancer CenterRecruiting
Los Angeles, California, United States
Valkyrie Clinical TrialsRecruiting
Los Angeles, California, United States
John Theurer Cancer Center at Hackensack University Medical CenterRecruiting
Hackensack, New Jersey, United States
Local Institution - 0045Not Yet Recruiting
Columbus, Ohio, United States
Local Institution - 0046Withdrawn
Dallas, Texas, United States
Local Institution - 0049Not Yet Recruiting
Houston, Texas, United States
BC Cancer VancouverRecruiting
Vancouver, British Columbia, Canada
Princess Margaret Cancer CentreRecruiting
Toronto, Ontario, Canada
Centre Hospitalier de l'Université de MontréalRecruiting
Montreal, Quebec, Canada
Jewish General HospitalRecruiting
Montreal, Quebec, Canada
Local Institution - 0036Not Yet Recruiting
Bordeaux, Aquitaine, France
Local Institution - 0031Not Yet Recruiting
Villejuif, Val-de-Marne, France
Local Institution - 0035Not Yet Recruiting
Lyon, France
Local Institution - 0033Not Yet Recruiting
Milan, Italy
Local Institution - 0032Not Yet Recruiting
Milan, Italy
Local Institution - 0042Not Yet Recruiting
Barcelona, Barcelona [Barcelona], Spain
Local Institution - 0041Not Yet Recruiting
Avda.Pio XII 36,, Spain