臨床研究等提出・公開システム

Date of registration	Mar. 30, 2022
Last modified on	June. 17, 2025
Trial ID	jRCT2031210708

Scientific Title	Phase I study of CBA-1535
Public Title	Phase I study of CBA-1535

Contact for Scientific Queries	Name	Tanaka Miseri
	Affiliation	Chiome Bioscience Inc.
	Address	Sumitomo-Fudosan Nishi-shinjuku bldg. No.6, 3-12-1 Honmachi, Shibuya-ku, Tokyo
	Telephone	+81-3-6383-3561
	E-mail	ir@chiome.co.jp
Contact for Public Queries	Name	Tanaka Miseri
	Affiliation	Chiome Bioscience Inc.
	Address	Sumitomo-Fudosan Nishi-shinjuku bldg. No.6, 3-12-1 Honmachi, Shibuya-ku, Tokyo
	Telephone	+81-3-6383-3561
	E-mail	ir@chiome.co.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 01, 2022
Actual date of first enrollment		June. 27, 2022
Target sample size		70
Study Type		Interventional
Study Design	allocation	non-randomized controlled trial
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
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 antibody drugs, including immune checkpoint inhibitor within 28 days prior to enrollment - Patients who received anti-cancer drug within 14 days prior to enrollment
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Solid tumor (standard therapy is not available, non-responder or intolerable)
Intervention(s)		Part 1: Dose escalation; CBA-1535 (single agent therapy) Part 2: Dose escalation; CBA-1535 + pembrolizumab (combination therapy)
Primary Outcome(s)		- Dose Limiting Toxicity - Adverse Event

Primary Sponsor	Chiome Bioscience Inc.

Secondary Sponsor

Name of Certified Review Board	National Cancer Center Institutional Review Board
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-3542-2511
Approval Status	Approval
Date of approval	May. 26, 2022

Plan to share IPD	No

Secondary ID(s)	NCT07016997
Issuing Authority	ClinicalTrials.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
5	June. 17, 2025	(this page)	Changes
4	Dec. 26, 2024	Detail	Changes
3	Jan. 18, 2024	Detail	Changes
2	Aug. 09, 2022	Detail	Changes
1	Mar. 30, 2022	Detail

List of change history