臨床研究等提出・公開システム

Date of registration	Aug. 29, 2018
Last modified on	Oct. 04, 2023
Trial ID	jRCT2080224028

Scientific Title	Open-label, uncontrolled, dose-escalation study of ONO-7475 given as monotherapy and combinations with ONO-4538 in patients with advanced or metastatic solid tumors (ONO-7475-02)
Public Title	ONO-7475 Phase I Study (ONO-7475-02)

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Phone Number	+81-120-626-190
	E-mail Address	clinical_trial@ono-pharma.com

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	3 -1 -1 Sakurai, Shimamoto-cho, Mishima-gun, Osaka
	Phone Number	+81-120-626-190
	E-mail Address	clinical_trial@ono-pharma.com

Recruitment Status	completed

Date of First Enrolment		Nov. 07, 2018
Target Sample Size		84
Study Type		Interventional
Study Design	Study Design	open-label, uncontrolled study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Patients with histologically or cytologically confirmed advanced or metastatic solid tumors 2. ECOG Performance Status 0-1 3. Patients with life expectancy of at least 3 months
	Exclusion Criteria	1. Patients with history of serious allergy 2. Patients with multiple cancers
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Solid tumors
Intervention(s)		investigational material(s) Generic name etc : ONO-7475 INN of investigational material : ONO-7475 Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral administration Generic name etc : ONO-4538 INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous administration 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 Tolerability, Safety
Secondary Outcome		pharmacokinetics Pharmacokinetics

Primary Sponsor	ONO PHARMACEUTICAL CO.,LTD.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Center Center Hospital IRB
Address of IRB	5-1-1 Tsukiji, Chuo-ku Tokyo
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Oct. 17, 2018

Secondary ID No.	NCT03730337
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-184087
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
10	Oct. 04, 2023	(this page)	Changes
9	Dec. 14, 2022	Detail	Changes
8	Dec. 20, 2021	Detail	Changes
7	May. 26, 2021	Detail	Changes
6	Oct. 14, 2020	Detail	Changes
5	April. 21, 2020	Detail	Changes
4	Sept. 05, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Aug. 29, 2018	Detail	Changes
1	Aug. 29, 2018	Detail

List of change history