NCT06476808RecruitingPhase 1
A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
Bristol-Myers Squibb30 sites in 5 countries240 target enrollmentStarted: September 6, 2024Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 240
- Locations
- 30
- Primary Endpoint
- Number of participants with serious adverse events (SAEs)
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or
- •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.
Arms & Interventions
Arm 2: Dose Expansion
Experimental
Intervention: BMS-986463 (Drug)
Arm 1: Dose Escalation
Experimental
Intervention: BMS-986463 (Drug)
Outcomes
Primary Outcomes
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 108 weeks
Number of participants with adverse events (AEs)
Time Frame: Up to 108 weeks
Number of participants with AEs leading to discontinuation
Time Frame: Up to 108 weeks
Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
Time Frame: Up to 108 weeks
Number of participants with AEs leading to death
Time Frame: Up to 108 weeks
Secondary Outcomes
- Maximum observed concentration (Cmax)(Up to 104 weeks)
- Time of maximum observed concentration (Tmax)(Up to 104 weeks)
- Objective response rate (ORR)(Up to 104 weeks)
- Disease control rate (DCR)(Up to 104 weeks)
- Duration of response (DOR)(Up to 104 weeks)
- Area under the concentration-time curve (AUC)(Up to 104 weeks)
Investigators
Study Sites (30)
Loading locations...
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