臨床研究等提出・公開システム

Date of registration	April. 20, 2020
Last modified on	Jan. 30, 2025
Trial ID	jRCT2080225170

Scientific Title	An open-label, uncontrolled, dose escalation study in patients with advanced or metastatic solid cancers (ONO-7913-01)
Public Title	ONO-7913 Phase I study (ONO-7913)

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		June. 30, 2020
Target Sample Size		12
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 of 0-1 3.Patients with life expectancy of at least 3 months
	Exclusion Criteria	1. Patients with multiple cancers 2. Patients with history of serious allergy
	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 : Magrolimab(ONO-7913) INN of investigational material : Magrolimab 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	May. 27, 2020

Secondary ID No.	NCT04403308
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-205266
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
5	Jan. 30, 2025	(this page)	Changes
4	May. 06, 2021	Detail	Changes
3	Oct. 14, 2020	Detail	Changes
2	July. 06, 2020	Detail	Changes
1	April. 21, 2020	Detail

List of change history