臨床研究等提出・公開システム

Date of registration	Nov. 06, 2018
Last modified on	June. 16, 2020
Trial ID	jRCT2080224133

Scientific Title	A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients with Advanced Solid Malignancies
Public Title	A Phase I, Open-label Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activity of MEDI9447 (Oleclumab) in Japanese Patients with Advanced Solid Malignancies

Completion Date or Terminated date	Aug. 30, 2019
Actual Enrolled Number
Baseline Characteristics
Participant flow
Adverse events
Primary Outcome Measures
Secondary Outcome Measures
Brief summary
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description
URL link to protocol file(s)
Version of protocol file(s)	version: date:

Contact for Scientific Queries	Name
	Contact Name for Scientific Queries	AstraZeneca KK
	Address	-
	Phone Number	-
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Contact for Public Queries	Name
	Contact Name for Public Queries	AstraZeneca KK
	Address	-
	Phone Number	-
	E-mail Address	RD-clinical-information-Japan@astrazeneca.com

Recruitment Status	completed

Date of First Enrolment		Nov. 17, 2018
Target Sample Size		12
Study Type		Interventional
Study Design	Study Design	single-arm, open label
Study Design	Objective	other
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	- Adult subjects; age 20 years or more - Has a histologically confirmed solid malignancy that is refractory to standard therapy or for which no standard of care regimen currently exists - Subjects must have at least 1 lesion that is measureable using RECIST v1.1 - All subjects must consent to provide archived tumor specimens for biomarker studies - ECOG Performance Status of 0 or 1 - Life expectancy 12 weeks or more - Adequate organ function - Body weight 35 kg or more
	Exclusion Criteria	- Patients must have completed any previous cancer-related treatments before enrollment - Prior treatment with CD73 antagonist, tumor necrosis factor receptor superfamily agonists - All CTLA-4, PD-1, or PD-L1 antagonists related-AEs must have resolved to NCI CTCAE v4.03 Grade 1 or less or baseline prior to screening and not worsened before the first dose of study drug - Must not have required the use of additional immunosuppression other than corticosteroids for the management of an CTLA-4, PD-1, or PD-L1 related AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of > 10 mg prednisone or equivalent per day - Known allergy or hypersensitivity to the study drug, its compounds, or agents similar biologic composition - History of more than one event of IRR requiring permanent discontinuation of IV drug treatment - History of severe drug allergies or anaphylaxis to 2 or more food products or medicine - Cardiac or peripheral vascular disease - NCI CTCAE v4.03 Grade 3 or greater edema - Uncontrolled massive ascites or pleural effusion - History of NCI CTCAE v4.03 Grade 3 or greater thromboembolic events within 3 months prior to the first dose of study drug or thromboembolic event of any grade with ongoing symptoms - Active tuberculosis - Patients with history of, or current ILD - Active or prior documented autoimmune within the past 3 years prior to the start of treatment - Untreated or unstable CNS metastatic disease, leptomeningeal disease, or cord compression - Concurrent enrollment in another clinical study - Any concurrent chemotherapy, immunotherapy, or biologic or hormonal therapy for cancer treatment - Toxicities from prior anticancer therapy that have not resolved to NCI CTCAE v4.03 Grade 1 or less or baseline prior to the first dose of study drug - History of primary immunodeficiency or solid organ transplantation - Active hepatitis B, hepatitis C, or HIV - Females who are pregnant, lactating, or intend to become pregnant during their participation in the study - Other invasive malignancy within 2 years prior to the first dose of study drug - Uncontrolled concomitant illnes - Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements - Involvement in the planning and/or conduct of the study
	Minimum Age	20age old over
	Maximum Age	No limit
	Gender	Both
Health Condition or Problem Studied		Advanced Solid Malignancies
Intervention(s)		investigational material(s) Generic name etc : MEDI9447(Oleclumab) INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Administer MEDI9447 intravenously 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 -
Secondary Outcome		efficacy pharmacokinetics pharmacodynamics -

Primary Sponsor	AstraZeneca
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	National Cancer Center 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. 31, 2018

Secondary ID No.	NCT03736473
Name of Other Registries	ClinicalTrials.gov

Secondary ID No.	JapicCTI-184194
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
7	June. 16, 2020	(this page)	Changes
6	June. 10, 2020	Detail	Changes
5	Dec. 17, 2018	Detail	Changes
4	Nov. 22, 2018	Detail	Changes
3	Nov. 22, 2018	Detail	Changes
2	Nov. 06, 2018	Detail	Changes
1	Nov. 06, 2018	Detail

List of change history