Advanced or metastatic solid tumors
Conditions
Interventions
Depends on the dose level, IT1208 is administered as once or twice IV infusion.
Sponsors
National Cancer Center Hospital East
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Occurrence rate of adverse events including the dose limited toxicity -Determination of maximum tolerated dose (MTD) and recommended dose (RD) of IT1208 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Profile of pharmacokinetics of IT1208 -Pharmacodynamics of IT1208 -Efficacy of IT1208 | — |
Countries
Japan
Contacts
Public ContactKohei Shitara
National Cancer Center Hospital East Gastrointestinal Oncology Division
Outcome results
None listed