臨床研究等提出・公開システム

Date of registration	Oct. 24, 2016
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223357

Scientific Title	A Phase 1 Study of the Safety and Tolerability of BMS 986148 in Subjects With Advanced and/or Metastatic Solid Tumors
Public Title	Phase 1 Study of BMS-986148

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries
	Address
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Bristol-Myers Squibb K.K.
	Address	mg-jp-clinical_trial@bms.com
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		15
Study Type		Interventional
Study Design	Study Design	Safety study, Single group assignment, Open label
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Subject with advanced and/or metastatic solid tumors which are expected to express mesothelin who received the previous treatment Must have measurable tumor per Response Evaluation Criteria in Solid Tumors (RECIST) or modified RECIST for malignant pleural mesothelioma Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
	Exclusion Criteria	Cancer metastases in the brain Uncontrolled or significant cardiovascular disease Moderate eye disorders Moderate peripheral neuropathy Known past or active hepatitis B or C infection
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Solid tumors
Intervention(s)		investigational material(s) Generic name etc : BMS-986148 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion every 3 weeks
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		Safety and tolerability of BMS-986148. Adverse event and Serious adverse event
Secondary Outcome		Preliminary anti-tumor activity of BMS-986148 To characterize the PK of the total antibody, active ADC and unconjugated tubulysin To characterize the immunogenicity of BMS-986148 Response Evaluation Criteria The following PK parameters of total antibody, active ADC and unconjugated tubulysin: Cmax, Tmax, AUC(0-T), AUC(TAU), Cavg, T-HALF, Ctrough, Ctau, CLT, Vss, Vz, AI_AUC, AI_Cmax and AI_Ctau Immunogenicity status

Primary Sponsor	Bristol-Myers Squibb K.K.
Secondary Sponsor

Name of Funding Organization
Name of Research Funding

Name of IRB
Address of IRB
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review
Date of Approval by IRB

Secondary ID No.	JapicCTI-163412
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Dec. 12, 2017	Detail	Changes
5	Dec. 12, 2017	Detail	Changes
4	June. 23, 2017	Detail	Changes
3	June. 23, 2017	Detail	Changes
2	Oct. 24, 2016	Detail	Changes
1	Oct. 24, 2016	Detail

List of change history