UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase I study of IT1208 in subjects with advanced or metastatic solid tumors
Title of the study (Brief title)	Anti CD4-phase1
Region	Japan

Condition
Condition	Advanced or metastatic solid tumors
Classification by specialty	Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the safety and tolerability of IT1208 in subjects with advanced or metastatic solid tumors.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase I

Assessment
Primary outcomes	-Occurrence rate of adverse events including the dose limited toxicity -Determination of maximum tolerated dose (MTD) and recommended dose (RD) of IT1208
Key secondary outcomes	-Profile of pharmacokinetics of IT1208 -Pharmacodynamics of IT1208 -Efficacy of IT1208

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Depends on the dose level, IT1208 is administered as once or twice IV infusion.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patient with advanced or metastatic solid tumors. 2) Patient with tumors resistant to standard therapy or without available standard therapy. 3) Patient has evaluable tumors by RECIST guideline version 1.1. 4) Patient 20 years or older 5) ECOG performance status is 0 or 1. 6) Organ function is defined by all of the following within 7 days prior to study registration. a) Absolute neutrophil count >= 1,500 /mm3 b) Platelets >= 100,000 /mm3 c) Absolute lymphocyte count >= 800 /mm3 d) Hemoglobin >= 9.0 g/dL e) Total serum bilirubin =< 1.5 mg/dL f) AST =< 100 U/L or =< 150 IU/L in case of documented liver metastasis. g) ALT =< 100 U/L or =< 150 IU/L in case of documented liver metastasis. h) Serum creatinine =< 1.5 mg/dL or calculated creatinine clearance by Cockcroft-Gault >= 50 mL/min i) HbA1c >= 8.0% 7) Any specific toxicities (excluding alopecia, peripheral sensory neuropathy, Skin hyperpigmentation, Dysgeusia) related to any prior anti-cancer therapy is resolved to =< grade 1 according to the CTCAE. 8) No use of transfusion or G-CSF within 7 days prior to study registration. 9) Patient agrees to use adequate contraception for the duration of study period and for 6 months after the last study treatment. A women of child-bearing potential must be negative of urine pregnancy test within 7 days prior to study registration. 10) The patient survival is expected to be longer than 3 months after first study treatment. 11) Patients with written informed consent form before study participation.
Key exclusion criteria	1) Patient who has primary central nervous system (CNS) tumor or advanced CNS metastases. Asymptomatic patient without steroid treatment with CNS metastases which have not progressed after local treatment can be enrolled. 2) Patient who has acquired immunodeficiency or active autoimmune disease with immune suppressive treatment. 3) Patient who has received anti-cancer therapy, radiotherapy or other investigational drug within 2 weeks prior to study registration. 4) Patient who has received an anti-CCR4, anti-PD-1, anti-PD-L1, anti-LAG3, anti-OX-40, anti-4-1BB, or an anti-TIM-3 antibody or IDO inhibitor or a therapy with genetically modified virus/cells within 4 weeks prior to study registration. 5) Patient who potentially has some foreign-body reactions to transplantation, foreign materials or implant. 6) Patient who has an active infectious disease with systemic therapy. (1) Patient with no history of hepatitis B vaccine who tests positive for HBs antigen, HBc antibody or HCV antibody. (2) Patient who has a history of tuberculosis or tests positive for QFT with symptom or image findings of tuberculosis. (3) Patient who has or is suspected to have bacterial infection or virus infection. 7) Patient who has symptom or image findings of interstitial pneumonia or pulmonary fibrosis. 8) Patient who has a significant cardiovascular disease (i.e. congestive heart failure (>= 3 of NYHA within 6 months prior to study registration, unstable angina, a history of myocardial infarction or concomitant cardiac infarction). 9) Patient who has uncontrollable diabetes. 10) Patient during pregnancy or lactation. 11) Patient without compliance of study protocol. 12) Patient who is considered to interfere with evaluation of the study drug or safety or interpretation of study results.
Target sample size	36

Research contact person
Name of lead principal investigator	Toshihiko Doi
Organization	National Cancer Center Hospital East
Division name	Department of Experimental Therapeutics
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL	04-7133-1111
Email	cd4-p1_core@east.ncc.go.jp

Public contact
Name of contact person	Kohei Shitara
Organization	National Cancer Center Hospital East
Division name	Gastrointestinal Oncology Division
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL	04-7133-1111
Homepage URL
Email	cd4-p1_core@east.ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital East
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)	Project of Translational and Clinical Research Core Centers

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立がん研究センター東病院(千葉県)

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 03 Day
Anticipated trial start date	2017 Year 03 Month 24 Day
Last follow-up date	2018 Year 05 Month 31 Day
Date of closure to data entry	2018 Year 06 Month 04 Day
Date trial data considered complete	2018 Year 06 Month 30 Day
Date analysis concluded	2018 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 15 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030498