臨床研究等提出・公開システム

Date of registration	June. 08, 2026
Last modified on	July. 23, 2026
Trial ID	jRCT2041260054

Scientific Title	ONO-7429-01:A phase 1, open-label, dose escalation study to investigate the safety and tolerability of ONO-7429 in participants with unresectable advanced or recurrent solid tumors
Public Title	ONO-7429-01:A phase 1 study of ONO-7429 in participants with unresectable advanced or recurrent solid tumors

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120278120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD.
	Address	8-2 Kyutaromachi, 1-Chome,Chuo-ku, Osaka-shi,Osaka, JAPAN
	Telephone	+81-120278120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 08, 2026
Target sample size		80
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	1. Participants with histologically or cytologically confirmed unresectable advanced or recurrent solid tumors. 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 4. Participants with tumor tissue samples available for biomarker testing.
	Exclusion Criteria	1. Participants with a history or presence of severe hypersensitivity to any other antibody agents. 2. Participants with pericardial fluid, pleural effusion or ascites requiring treatment 3. Participants with uncontrolled tumor-related pain 4. Participants with severe peritoneal dissemination. 5. Participants with multiple primary cancers. 6. Participants with a history or presence of ILD or pulmonary fibrosis.
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Unresectable advanced or recurrent solid tumors
Intervention(s)		Administration of ONO-7429
Primary Outcome(s)		Tolerability, safety
Secondary Outcome(s)		Efficacy, Pharmacokinetics (PK), and Immunogenicity

Primary Sponsor	Ono Pharmaceutical Co.,LTD.

Secondary Sponsor

Secondary Sponsor

Name of Certified Review Board	Shizuoka Cancer Center Review Board
Address	1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka
Telephone	+81-55-989-5222
E-Mail	kenkyusuishin@scchr.jp
Approval Status	Approval
Date of approval	June. 05, 2026

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
2	July. 23, 2026	(this page)	Changes
1	June. 08, 2026	Detail

List of change history