Actively Recruiting
A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
Led by Bristol-Myers Squibb · Updated on 2026-04-15
240
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and efficacy of increasing doses of BMS-986463 in adults with select advanced malignant tumors, including high-grade serous ovarian carcinoma, uterine serous carcinoma, and non-small cell lung cancer. This phase 1/1b study aims to understand how the drug works and its effects in these cancer types. The study is sponsored by Bristol-Myers Squibb and includes participants with unresectable or metastatic carcinoma who meet specific health criteria. Participants will receive BMS-986463 at specified doses on designated days. The study includes two experimental arms: dose escalation and dose expansion. Treatment details such as dosing schedules are determined by protocol, and participants will be closely monitored throughout the study period, which may last up to 108 weeks for safety and efficacy assessments. During the study, participants will undergo fresh biopsies before treatment to collect tumor samples. Researchers will monitor adverse events, including serious side effects and those leading to treatment discontinuation or death. Pharmacokinetic measures like drug concentration and response rates such as objective response and disease control will also be evaluated. The total participation duration can extend up to approximately two years, with ongoing safety and efficacy assessments throughout this time.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- Participants must not have Leptomeningeal metastases.
- Participants must not have concurrent malignancy requiring treatment or a 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 108 weeks
Participants receive escalating doses of BMS-986463 on specified days to evaluate safety, tolerability, and efficacy.
Trial Site Locations
Total: 17 locations
1
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Actively Recruiting
2
Valkyrie Clinical Trials
Los Angeles, California, United States, 90067
Actively Recruiting
3
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
4
Local Institution - 0045
Columbus, Ohio, United States, 43210
Not Yet Recruiting
5
Local Institution - 0046
Dallas, Texas, United States, 75390
Not Yet Recruiting
6
Local Institution - 0049
Houston, Texas, United States, 77054
Not Yet Recruiting
7
BC Cancer Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
8
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
9
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
10
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
11
Local Institution - 0036
Bordeaux, Aquitaine, France, 33076
Not Yet Recruiting
12
Local Institution - 0031
Villejuif, Val-de-Marne, France, 94800
Not Yet Recruiting
13
Local Institution - 0035
Lyon, France, 69373
Not Yet Recruiting
14
Local Institution - 0033
Milan, Italy, 20141
Not Yet Recruiting
15
Local Institution - 0032
Milan, Italy, 20159
Not Yet Recruiting
16
Local Institution - 0042
Barcelona, Barcelona [Barcelona], Spain, 08035
Not Yet Recruiting
17
Local Institution - 0041
Avda.Pio XII 36,, Spain, 31008
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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