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Trial Title:
A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.
NCT ID:
NCT06476808
Condition:
High-grade Serous Ovarian Carcinoma (HGSOC)
Uterine Serous Carcinoma (USC)
Non-small Cell Lung Cancer (NSCLC)
Conditions: Official terms:
Carcinoma
Cystadenocarcinoma, Serous
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BMS-986463
Description:
Specified dose on specified days
Arm group label:
Arm 1: Dose Escalation
Arm group label:
Arm 2: Dose Expansion
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
USC/Norris Comprehensive Cancer Center
Address:
City:
Los Angeles
Zip:
90033
Country:
United States
Status:
Recruiting
Contact:
Last name:
Anastasia Martynova, Site 0003
Phone:
310-226-2905
Facility:
Name:
Valkyrie Clinical Trials
Address:
City:
Los Angeles
Zip:
90067
Country:
United States
Status:
Recruiting
Contact:
Last name:
David Berz, Site 0006
Phone:
424-535-1874
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Martin Gutierrez, Site 0001
Phone:
551-996-5863
Facility:
Name:
Local Institution - 0026
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Site 0026
Facility:
Name:
Local Institution - 0027
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Site 0027
Facility:
Name:
Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Susie Lau, Site 0024
Phone:
5143408222ext23114
Start date:
September 6, 2024
Completion date:
December 19, 2028
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06476808
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06476808.html
