UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026564
Receipt number R000030498
Scientific Title Phase I study of IT1208 in subjects with advanced or metastatic solid tumors
Date of disclosure of the study information 2017/03/21
Last modified on 2018/09/14 09:08:12

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Basic information

Public title

Phase I study of IT1208 in subjects with advanced or metastatic solid tumors

Acronym

Anti CD4-phase1

Scientific Title

Phase I study of IT1208 in subjects with advanced or metastatic solid tumors

Scientific Title:Acronym

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

1st name
Middle name
Last name Toshihiko Doi

Organization

National Cancer Center Hospital East

Division name

Department of Experimental Therapeutics

Zip code


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

1st name
Middle name
Last name Kohei Shitara

Organization

National Cancer Center Hospital East

Division name

Gastrointestinal Oncology Division

Zip code


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 or person

Institute

National Cancer Center Hospital East

Institute

Department

Personal name



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


IRB Contact (For public release)

Organization


Address


Tel


Email



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


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 02 Month 03 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name