臨床研究等提出・公開システム

Date of registration	Jan. 18, 2017
Last modified on	June. 04, 2025
Trial ID	jRCT2080223441

Scientific Title	ONO-4578-01:Phase 1 dose escalating and expansion study of ONO-4578 given as monotherapy and combinations of ONO-4578 and ONO-4538 in subjects with advanced or metastatic solid tumors
Public Title	ONO-4578 Phase 1 Study (ONO-4578-01)

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Phone Number	+81-120278120
	E-mail Address	clinical_trial@ono-pharma.com

Contact for Public Queries	Name
	Contact Name for Public Queries	ONO PHARMACEUTICAL CO.,LTD.
	Address	1-8-2 Kyutaromachi, Chuo-ku Osaka-shi, Osaka-fu Japan
	Phone Number	+81-120278120
	E-mail Address	clinical_trial@ono-pharma.com

Recruitment Status	completed

Date of First Enrolment		April. 19, 2017
Target Sample Size		183
Study Type		Interventional
Study Design	Study Design	Open-label, non-randomized, dose escalating and expansion study
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	1. Advanced or metastatic solid tumors (Part A, B) 2. Unresectable, advanced or recurrent gastric cancer (Part C) 3. Unresectable, advanced or recurrent colorectal cancer(Part D) 4. Life expectancy of at least 3 months 5. Patients with ECOG performance status 0 or 1
	Exclusion Criteria	1. Patients with severe complication 2. Patients with multiple primary cancers
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced or metastatic solid tumors (Part A, B) Unresectable, advanced or recurrent gastric cancer (Part C) Unresectable, advanced or recurrent colorectal cancer(Part D)
Intervention(s)		investigational material(s) Generic name etc : ONO-4578 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Oral administration Generic name etc : ONO-4538(Nivolumab) 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 Safety, tolerability
Secondary Outcome		pharmacokinetics Pharmacokinetics

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

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Cancer Center Hospital
Address of IRB	5-1-1 Tsukiji Chuo-ku Tokyo, Japan 104-0045
Phone Number of IRB
E-mail Address of IRB
Status of IRB Review	approved
Date of Approval by IRB	Mar. 08, 2017

Secondary ID No.	NCT03155061
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-173496
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
14	June. 04, 2025	(this page)	Changes
13	Aug. 22, 2024	Detail	Changes
12	Dec. 14, 2022	Detail	Changes
11	Dec. 20, 2021	Detail	Changes
10	Sept. 10, 2021	Detail	Changes
9	Oct. 14, 2020	Detail	Changes
8	July. 02, 2020	Detail	Changes
7	May. 18, 2020	Detail	Changes
6	April. 21, 2020	Detail	Changes
5	Sept. 12, 2019	Detail	Changes
4	Sept. 05, 2019	Detail	Changes
3	Dec. 17, 2018	Detail	Changes
2	Jan. 18, 2017	Detail	Changes
1	Jan. 18, 2017	Detail

List of change history