Clinical trial NCT06476808: A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
Official title: A Phase 1/1b First-in-human Study of BMS-986463 in Advanced Malignant Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: High-grade Serous Ovarian Carcinoma (HGSOC)
Uterine Serous Carcinoma (USC)
Non-small Cell Lung Cancer (NSCLC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-06-26
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 108 weeks
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 108 weeks
measure: Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria
timeFrame: Up to 108 weeks
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 108 weeks
measure: Number of participants with AEs leading to death
timeFrame: Up to 108 weeks
Secondary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 104 weeks
measure: Area under the concentration-time curve (AUC)
timeFrame: Up to 104 weeks
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 104 weeks
measure: Objective response rate (ORR)
timeFrame: Up to 104 weeks
measure: Disease control rate (DCR)
timeFrame: Up to 104 weeks
measure: Duration of response (DOR)
timeFrame: Up to 104 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Los Angeles
country: United States
facility: Valkyrie Clinical Trials
state: California
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Vancouver
country: Canada
facility: BC Cancer Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: