臨床研究等提出・公開システム

Japanese

Date of registration	July. 24, 2024
Last modified on	July. 24, 2024
Trial ID	jRCT2031240229

Scientific Title	A Phase 1/2 Study of BMS-986340 as Monotherapy and in Combination with Nivolumab or Docetaxel in Participants with Advanced Solid Tumors
Public Title	A Phase 1/2 Study of BMS-986340 in Participants with Advanced Solid Tumors (CA052002)

Contact for Scientific Queries	Name	Oza Jay
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	mg-jp-clinical_trial@bms.com
Contact for Public Queries	Name	Oza Jay
	Affiliation	Bristol-Myers Squibb
	Address	1-2-1 Otemachi, Chiyoda-ku, Tokyo
	Telephone	+81-120-093-507
	E-mail	MG-JP-RCO-JRCT@bms.com

Recruitment status	Recruiting

Anticipated date of first enrollment		July. 24, 2024
Actual date of first enrollment
Target sample size		665
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	- Fresh pre-treatment and on-treatment tumor biopsy must be provided for biomarker analysis - Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and at least 1 lesion accessible for biopsy. Fine needle biopsy, cytology, and bone lesion biopsies are not acceptable. - Eastern Cooperative Oncology Group Performance Status of 0 or 1 - Radiographically documented progressive disease on or after the most recent therapy - Received standard-of-care therapies, (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available programmed death (ligand)-1 inhibitor known to be effective in the tumor type for which they are being evaluated - Advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant of existing therapies known to provide clinical benefit for the condition of the participant
	Exclusion Criteria	- Women who are pregnant or breastfeeding - Primary central nervous system (CNS) malignancy - Untreated CNS metastases - Leptomeningeal metastases - Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to the first dose of study treatment - Active, known, or suspected autoimmune disease - Condition requiring systemic treatment with either corticosteroids within 14 days or other immunosuppressive medications within 30 days of the first dose of study treatment - Prior organ or tissue allograft - Uncontrolled or significant cardiovascular disease - Major surgery within 4 weeks of study drug administration History of or with active interstitial lung disease or pulmonary fibrosis
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		CC Gastric/GEJ Adenocarcinoma MSS-CRC NSCLC SCCHN RCC UC PAC Melanoma ONs TNBC
Intervention(s)		Drug: BMS-986340 Drug: Nivolumab Drug: Docetaxe(Ex-Japan)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		adverse event, serious adverse event, dose-limiting toxicity, etc.
Secondary Outcome(s)		PK, Incidence of anti-drug antibodies, ORR, DCR, DOR, PFSR, etc.

Primary Sponsor	Bristol-Myers Squibb

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Ctr IRB #2-J
Address	5-1-1, Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	Chiken_CT@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	May. 22, 2024

Plan to share IPD	No
Plan description

Secondary ID(s)	NCT04895709
Issuing Authority	CT.gov

Countries of Recruitment（Except Japan）	United States/Australia/Canada/Germany/Israelc/Italy/Spain