臨床研究等提出・公開システム

Date of registration	July. 21, 2020
Last modified on	July. 08, 2026
Trial ID	jRCT2080225288

Scientific Title	Phase I study of CBA-1205
Public Title	Phase I study of CBA-1205

Contact for Scientific Queries	Name	Tanaka Miseri
	Contact Name for Scientific Queries	Chiome Bioscience Inc.
	Address	3-12-1 Honmachi, Shibuya-ku, Tokyo 151-0071 Japan
	Phone Number	+81-3-6383-3561
	E-mail Address	ir@chiome.co.jp

Contact for Public Queries	Name	Tanaka Miseri
	Contact Name for Public Queries	Chiome Bioscience Inc.
	Address	3-12-1 Honmachi, Shibuya-ku, Tokyo 151-0071 Japan
	Phone Number	+81-3-6383-3561
	E-mail Address	ir@chiome.co.jp

Recruitment Status	recruiting

Date of First Enrolment		July. 28, 2020
Target Sample Size		66
Study Type		Interventional
Study Design	Study Design	Multicenter, non-randomized, open-label
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- ECOG performance status: <= 1 - Patients with 3 months or longer life expectancy
	Exclusion Criteria	- Patients who received other investigational drug or immune checkpoint inhibitor within 28 days prior to enrollment - Patients who received anti-cancer drug within 14 days prior to enrollment
	Minimum Age	2age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Solid Tumors, Hepatocellular Carcinoma, Malignant Melanoma, Pediatric Cancer
Intervention(s)		investigational material(s) Generic name etc : CBA-1205 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenious infusion, pre-specified dose 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 - Dose limiting toxicity - Adverse event
Secondary Outcome		efficacy pharmacokinetics other - Tumor response - Tumor marker - Serum concentration of CBA-1205 - Serum concentration of anti-CBA-1205 antibody

Primary Sponsor	Chiome Bioscience Inc.
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
Status of IRB Review	approved
Date of Approval by IRB	July. 08, 2020

Secondary ID No.	JapicCTI-205384
Name of Other Registries

Secondary ID No.	NCT06636435
Name of Other Registries	Clinical trials. gov

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
6	July. 08, 2026	(this page)	Changes
5	Aug. 20, 2025	Detail	Changes
4	Jan. 22, 2024	Detail	Changes
3	June. 25, 2023	Detail	Changes
2	Aug. 01, 2022	Detail	Changes
1	July. 21, 2020	Detail

List of change history