臨床研究等提出・公開システム

Date of registration	Nov. 14, 2013
Last modified on	Jan. 22, 2020
Trial ID	jRCT2080222290

Scientific Title	A phase 1 clinical study of WT2725 in patients with advanced solid malignancies.
Public Title	A phase 1 clinical study of WT2725 in patients with advanced solid malignancies.

Completion Date or Terminated date	May. 22, 2015
Actual Enrolled Number	8
Baseline Characteristics	Eight patients were enrolled, of whom 2 were withdrawn prior to study treatment. Of the 6 patients who received the investigational product and were evaluated for safety, 4 were male and 2 were female. The mean age was 58.5 years (minimum, 39 years; maximum, 68 years). All 6 patients had HLA-A*02:01.
Participant flow	Of the 8 enrolled patients, 2 patients discontinued prior to study treatment, and a total of 6 patients, 3 in Cohort 1 and 3 in Cohort 2, were evaluated safety and DLT.
Adverse events	No DLT was observed in the both cohorts. Five adverse events occurred in 3 patients. Two events of Nasopharyngitis and Dysphonia in 1 patient in cohort 1, and three events of Injection site swelling, Hyperglycaemia, Insomnia in 2 patients in cohort 2. No deaths or other serious adverse events were reported.
Primary Outcome Measures	No DLT was observed in the both cohorts. Five adverse events occurred in 3 patients. Two events of Nasopharyngitis and Dysphonia in 1 patient in cohort 1, and three events of Injection site swelling, Hyperglycaemia, Insomnia in 2 patients in cohort 2. No deaths or other serious adverse events were reported.
Secondary Outcome Measures	Best response was 1 irSD, 2 irPD in Cohort 1, 1 irSD, and 2 irPD in Cohort 2. The median irPFS was 7.07 weeks (95%CI 4. 00-35.00) and the median irOS was 31.79 weeks (95%CI 27. 86-NA).
Brief summary	This study was conducted to assess the safety of WT2725 in patients with advanced solid tumors, to determine MTDs, and to exploratory evaluate efficacy and biomarkers. No DLT was observed in any of the cohorts, and due to a change in the development plan, three additional patients were added to Cohort 2, and the MTD could not be determined because they were not evaluated in six patients.
Posting of journal publication
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	Undecided
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	Sumitomo Dainippon Pharma Co., Ltd.
	Address
	Phone Number
	E-mail Address	cc@ds-pharma.co.jp

Contact for Public Queries	Name
	Contact Name for Public Queries	Sumitomo Dainippon Pharma Co., Ltd.
	Address
	Phone Number
	E-mail Address	cc@ds-pharma.co.jp

Recruitment Status	completed

Date of First Enrolment		Jan. 10, 2014
Target Sample Size		6
Study Type		Interventional
Study Design	Study Design	Open-label, uncontrolled, dose-ascending
Study Design	Objective	treatment purpose
Phase		1
Key inclusion & exclusion criteria	Inclusion Criteria	out-patient Main Inclusion criteria - Patients >= 20 year old at informed consent - ECOG performance status: 0 or 1 - Histologically or cytologically diagnosed as solid tumor - Refractory to standard treatment or no standard treatment is established
	Exclusion Criteria	Main Exclusion criteria - Positive for HIV and HCV antibody, HBV surface antigen within 90 days prior to enrollment - Symptomatic brain metastasis - Previous treatment with WT2725 or WT1 peptide
	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 : WT2725 INN of investigational material : - Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Subcutaneous 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 - Maximum tolerated dose (MTD) - Adverse Event, side effect - clinical laboratory tests, vital signs measurements, body weight measurements, and electrocardiogram (ECG) results, chest X-ray examination
Secondary Outcome		efficacy Efficacy Tumor assessment

Primary Sponsor	Sumitomo Dainippon Pharma Co., Ltd.
Secondary Sponsor	-

Name of Funding Organization	-
Name of Research Funding	-

Name of IRB	-
Address of IRB	-
Phone Number of IRB	-
E-mail Address of IRB	-
Status of IRB Review	approved
Date of Approval by IRB	Nov. 27, 2013

Secondary ID No.	JapicCTI-132339
Name of Other Registries

Countries / Regions of Recruitment	Japan

History of Changes

No	Publication date
8	Jan. 22, 2020	(this page)	Changes
7	Dec. 17, 2018	Detail	Changes
6	July. 16, 2015	Detail	Changes
5	July. 16, 2015	Detail	Changes
4	Jan. 29, 2015	Detail	Changes
3	Jan. 29, 2015	Detail	Changes
2	Nov. 14, 2013	Detail	Changes
1	Nov. 14, 2013	Detail

List of change history