臨床研究等提出・公開システム

Date of registration	Jan. 30, 2025
Last modified on	Nov. 04, 2025
Trial ID	jRCT2031240647

Scientific Title	ONO-7428-01: A phase I, open-label, dose escalation study to evaluate the tolerability and safety of ONO-7428 in participants with unresectable advanced or recurrent solid tumors
Public Title	ONO-7428-01: A phase I study of ONO-7428 in participants with unresectable advanced or recurrent solid tumors

Contact for Scientific Queries	Name	Terasawa Tetsuji
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com
Contact for Public Queries	Name	JP Clinical Trial Support Desk
	Affiliation	Ono Pharmaceutical Co.,LTD
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Telephone	+81-120-278-120
	E-mail	clinical_trial@ono-pharma.com

Recruitment status	Recruiting

Anticipated date of first enrollment		April. 01, 2025
Actual date of first enrollment		April. 21, 2025
Target sample size		60
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. [Backfill cohort only] Participants with histologically or cytologically confirmed Stage IIIB, IIIC, IV, or recurrent NSCLC according to UICC-TNM classification . 2. Participants who are refractory or intolerant to standard therapy. 3. Participants with a tumor type for which anti-PD-(L)1 antibodies have been approved and who have previously treated with anti-PD-(L)1 antibody containing regimen. 4. Participants with Eastern Cooperative Oncology Group Performance Status 0 or 1. 5. Participants with tumor tissue samples available for biomarker testing.
	Exclusion Criteria	1. Participants with a complication or history of severe hypersensitivity to any other antibody drugs. 2. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease 3. Participants with severe peritoneal dissemination. 4. Participants with pericardial fluid, pleural effusion, or ascites requiring treatment. 5. Participants with uncontrolled tumor-related pain. 6. Participants with active or history of interstitial lung disease 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-7428
Primary Outcome(s)		Tolerability, safety

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	Institutional Review Board of The Cancer Institute Hospital Of JFCR
Address	3-8-31, Ariake, Koto, Tokyo
Telephone	+81-3-3520-0111
Approval Status	Approval
Date of approval	Feb. 05, 2025

Plan to share IPD	No

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
4	Nov. 04, 2025	(this page)	Changes
3	June. 02, 2025	Detail	Changes
2	April. 22, 2025	Detail	Changes
1	Jan. 30, 2025	Detail

List of change history