臨床研究等提出・公開システム

Date of registration	Nov. 09, 2017
Last modified on	Dec. 17, 2018
Trial ID	jRCT2080223708

Scientific Title	PHASE I STUDY OF RO6958688 +/- OTHER ANTI-CANCER AGENTS IN PATIENTS WITH ADVANCED SOLID TUMORS
Public Title	PHASE I STUDY OF RO6958688 +/- OTHER ANTI-CANCER AGENTS IN PATIENTS WITH ADVANCED SOLID TUMORS

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	clinical-trials@chugai-pharm.co.jp
	Phone Number
	E-mail Address

Recruitment Status

Date of First Enrolment
Target Sample Size		36
Study Type		Interventional
Study Design	Study Design	multicenter, Open-label, dose-escalation study
Study Design	Objective
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	Advanced or recurrent cancer that is refractory or ineligible to standard therapy or for which no standard therapy exists. Histologically or cytologically confirmed solid tumor. Confirmation of CEA-positivity at the sponsor-designated central laboratory ECOG PS of 0 or 1. Life expectancy >= 12 weeks from the date of enrollment. Major organ function meets all criteria.
	Exclusion Criteria	Pregnant or lactating woman. Current or previous autoimmune disease. History of adverse drug reactions that were considered to be immune-mediated, or severe as a result of cancer immunotherapy, including immune checkpoint inhibitors. Positive test result for human immunodeficiency virus (HIV) antibody, hepatitis B surface (HBs) antigen, HBs antibody, hepatitis B core (HBc) antibody, or hepatitis C virus (HCV) antibody (eligible if HCV-RNA-negative).
	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 : RO6958688 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion control material(s) Generic name etc : Atezolizumab INN of investigational material : Atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous infusion
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		DLT, AE, PK NCI CTCAE, PK parameter
Secondary Outcome		Efficacy, ATA RECIST, ATA

Primary Sponsor	CHUGAI PHARMACEUTICAL CO., LTD.
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-173764
Name of Other Registries

Countries / Regions of Recruitment

History of Changes

No	Publication date
7	Dec. 17, 2018	(this page)	Changes
6	Sept. 13, 2018	Detail	Changes
5	Sept. 13, 2018	Detail	Changes
4	Feb. 01, 2018	Detail	Changes
3	Feb. 01, 2018	Detail	Changes
2	Nov. 09, 2017	Detail	Changes
1	Nov. 09, 2017	Detail

List of change history