臨床研究等提出・公開システム

Date of registration	Dec. 28, 2021
Last modified on	June. 02, 2025
Trial ID	jRCT2031210530

Scientific Title	ONO-7914-01:A Phase I, open-label, uncontrolled, dose escalation study to evaluate the tolerability and safety of ONO-7914 alone and in combination with ONO-4538 in patients with advanced or metastatic solid tumors
Public Title	ONO-7914-01:Phase I study of ONO-7914 alone and in combination with ONO-4538 in patients with solid tumors

Contact for Scientific Queries	Name	Hirashima Yoshinori
	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.co.jp
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.co.jp

Recruitment status	Complete

Anticipated date of first enrollment		Jan. 31, 2022
Actual date of first enrollment		Feb. 08, 2022
Target sample size		204
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	1.Patients with advanced or metastatic solid tumor 2.Patients with ECOG performance status of 0 or 1 3.Patients with a life expectancy of at least 3 months
	Exclusion Criteria	1.Patients with severe complication 2.Patients judged to be incapable of providing consent for reasons such as concurrent dementia
	Age Minimum	20age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		advanced or metastatic solid tumors
Intervention(s)		ONO-7914 is administered as a single agent or combination with ONO-4538.
Primary Outcome(s)		Safety and tolerability
Secondary Outcome(s)		Pharmacokinetics for ONO-7914 and ONO-4538

Primary Sponsor	Ono Pharmaceutical Co.,LTD

Name of Certified Review Board	The Cancer Institute Hospital of JFCR Institutional Review Board
Address	3-8-31, Ariake, Koto-ku, Tokyo
Telephone	+81-3-3520-0111
E-Mail	tiken_office@ml.jfcr.or.jp
Approval Status	Approval
Date of approval	Jan. 04, 2022

Plan to share IPD	No

Secondary ID(s)	NCT06535009

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
7	June. 02, 2025	(this page)	Changes
6	Feb. 20, 2025	Detail	Changes
5	Nov. 15, 2024	Detail	Changes
4	Sept. 04, 2024	Detail	Changes
3	June. 21, 2022	Detail	Changes
2	Jan. 23, 2022	Detail	Changes
1	Dec. 28, 2021	Detail

List of change history