臨床研究等提出・公開システム

Date of registration	May. 14, 2019
Last modified on	Dec. 28, 2020
Trial ID	jRCT2080224681

Scientific Title	An open label, Phase I study of BI 836880 monotherapy and combination therapy of BI 836880 and BI 754091 in Japanese patients with advanced solid tumours
Public Title	A study to find the best dose of BI 836880 alone and in combination with BI 754091 in Japanese patients with different types of advanced cancer

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Nippon Boehringer Ingelheim Co., Ltd.
	Address	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
	Phone Number	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
	E-mail Address	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

Contact for Public Queries	Name
	Contact Name for Public Queries	Nippon Boehringer Ingelheim Co., Ltd.
	Address	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
	Phone Number	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B
	E-mail Address	https://www.boehringer-ingelheim.jp/%E6%B2%BB%E9%A8%93%E3%81%AB%E9%96%A2%E3%81%99%E3%82%8B%E3%81%8A%E5%95%8F%E3%81%84%E5%90%88%E3%82%8F%E3%81%9B

Recruitment Status	completed

Date of First Enrolment		June. 17, 2019
Target Sample Size		21
Study Type		Interventional
Study Design	Study Design	Open label, uncontrolled, non-randomised, dose-escalation design
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Good Clinical Practice (GCP) and local legislation prior to admission to the trial. 2. Patients with a confirmed diagnosis of advanced, unresectable, and/or metastatic solid tumours (any type).
	Exclusion Criteria	1. Known hypersensitivity to the trial drugs or their excipients 2. Known HIV, HBV, or HCV infection 3. History of severe hypersensitivity reactions to other mAbs
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		advanced solid tumours
Intervention(s)		investigational material(s) Generic name etc : BI 836880, BI 754091 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : i.v. every three weeks control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : --- Other Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety - MTD. - Number of patients with DLTs in the MTD evaluation period.
Secondary Outcome		pharmacokinetics PK parameters

Primary Sponsor	Nippon Boehringer Ingelheim Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Cancer Center Institutional Review Board
Address of IRB	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045 Japan
Phone Number of IRB	+81-3-3542-2511
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	May. 29, 2019

Secondary ID No.	JapicCTI-194755
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
4	Dec. 28, 2020	(this page)	Changes
3	Jan. 17, 2020	Detail	Changes
2	Jan. 14, 2020	Detail	Changes
1	May. 14, 2019	Detail

List of change history