臨床研究等提出・公開システム

Scientific Title	Phase I study of SOF10 in combination with antineoplastic drugs in patients with advanced solid tumors
Public Title	Phase I study of SOF10 in patients with advanced solid tumors

Contact for Scientific Queries	Name	Awaya Norihiro
	Affiliation	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo
	Telephone	+81-120-189-706
	E-mail	clinical-trials@chugai-pharm.co.jp
Contact for Public Queries	Name	Clinical trials information
	Affiliation	Chugai Pharmaceutical Co., Ltd.
	Address	1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku Tokyo
	Telephone	+81-120-189-706
	E-mail	clinical-trials@chugai-pharm.co.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		May. 01, 2021
Actual date of first enrollment		May. 31, 2021
Target sample size		66
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	- Aged >20 years at time of informed consent - Eastern Cooperative Oncology Group(ECOG) Performance Status (PS) of 0 or 1 - Life expectancy >12 weeks from date of enrollment - Histologically or cytologically documented solid tumor - Advanced or recurrent cancer for which standard therapy is ineffective or inappropriate, or for which no standard therapy exists
	Exclusion Criteria	- Concurrent or prior autoimmune disease - Uncontrolled diabetes mellitus - Concurrent New York Heart Association (NYHA) Class >II congestive heart failure, myocardial infarction, arrhythmia, or unstable angina, or a history thereof within 6 months before enrollment - Concurrent symptomatic cerebrovascular disorder or a history thereof within 6 months before enrollment
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Solid Tumor
Intervention(s)		SOF10: Specified dose, IV Atezolizumab: Specified dose, IV
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Safety, Phamacokinetics NCI CTCAE
Secondary Outcome(s)		Efficacy RECIST

Primary Sponsor	Chugai Pharmaceutical Co., Ltd.

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	National Cancer Ctr IRB#2-j
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo
Telephone	+81-3-3542-2511
E-Mail	Chiken_CT@ml.res.ncc.go.jp
Approval Status	Approval
Date of approval	April. 21, 2021

Plan to share IPD	Yes
Plan description	Qualified researchers may request access to individual patient level data through the clinical study data request platform. For further details on Chugai's Data Sharing Policy and how to request access to related clinical study documents, see here (www.chugai-pharm.co.jp/english/profile/rd/ctds_request.html).

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history