High-grade Serous Ovarian Carcinoma (HGSOC), Non-small Cell Lung Cancer (NSCLC), Uterine Serous Carcinoma (USC)
Conditions
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.
Interventions
DRUGBMS-986463
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| Number of participants with AEs leading to discontinuation | Up to 108 weeks |
| Number of participants with AEs leading to death | Up to 108 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) | Up to 104 weeks |
| Area under the concentration-time curve (AUC) | 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 |
Countries
Canada, France, Italy, Spain, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed