臨床研究等提出・公開システム

Date of registration	July. 22, 2016
Last modified on	May. 19, 2025
Trial ID	jRCT2080223270

Scientific Title	A PHASE I, OPEN-LABEL, MULTI-CENTER, DOSE-ESCALATION STUDY OF CODRITUZUMAB, AN ANTI-GLYPICAN-3 MONOCLONAL ANTIBODY, IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Public Title	A PHASE I STUDY OF CODRITUZUMAB, IN COMBINATION WITH ATEZOLIZUMAB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo, JAPAN
	Phone Number	+81-120-189-706
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 NIHONBASHI-MUROMACHI 2-CHOME, CHUO-KU, Tokyo, JAPAN
	Phone Number	+81-120-189-706
	E-mail Address	clinical-trials@chugai-pharm.co.jp

Recruitment Status	completed

Date of First Enrolment		Aug. 29, 2016
Target Sample Size		27
Study Type		Interventional
Study Design	Study Design	Open-label, multi-center, dose-escalation
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Histologically confirmed hepatocellular carcinoma with Glypican-3 staining on tumor by immunohistochemistry >= 2. - Prior treatment with at least 1 systemic agent. - Male or female >= 18 years old. - Eastern Cooperative Oncology Group Performance Status of 0-1. - Child-Pugh score 5-7.
	Exclusion Criteria	- History of autoimmune disease. - Prior treatment with anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
	Minimum Age	18age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		locally advanced or metastatic hepatocellular carcinoma
Intervention(s)		investigational material(s) Generic name etc : Codrituzumab INN of investigational material : codrituzumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Specified dose, IV Generic name etc : atezolizumab INN of investigational material : atezolizumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Specified dose, IV control material(s) Generic name etc : - INN of investigational material : - Therapeutic category code : Dosage and Administration for Investigational material : -
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome		safety Endpoints:MTD Method:NCI CTCAE
Secondary Outcome		safety efficacy pharmacokinetics Endpoints:Safety, anti-tumor activity, PK Method:NCI CTCAE, RECIST

Primary Sponsor	CHUGAI PHARMACEUTICAL 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
Phone Number of IRB	+81-3-3542-2511
E-mail Address of IRB	Chiken_CT@ml.res.ncc.go.jp
Status of IRB Review	approved
Date of Approval by IRB	July. 27, 2016

Secondary ID No.	JapicCTI-163325
Name of Other Registries

Countries / Regions of Recruitment	Japan/Taiwan

History of Changes

No	Publication date
9	May. 19, 2025	(this page)	Changes
8	May. 23, 2022	Detail	Changes
7	Dec. 17, 2018	Detail	Changes
6	May. 16, 2018	Detail	Changes
5	May. 16, 2018	Detail	Changes
4	Sept. 07, 2017	Detail	Changes
3	Sept. 07, 2017	Detail	Changes
2	July. 22, 2016	Detail	Changes
1	July. 22, 2016	Detail

List of change history