Phase I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.
Phase 1
- Conditions
- Malignant solid tumor
- Registration Number
- JPRN-UMIN000008007
- Lead Sponsor
- Mie University Graduate School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
1) Past history of severe hypersensitivity. 2) Positive for HBs antigen, HCV antibody or HIV antibody. 3) Experience of autoimmune disease requiring treatment during 6 months prior to consent. 4) Active multiple primary malignancy. 5) Patient with disease requiring emergent radiotherapy. 6) Use of steroids (PSL >= 20mg / day) or immune-suppressive drugs. 7) Patients with severe complications. 8) History of other NY-ESO-1 related immunotherapy. 9) Pregnant or breastfeeding. 10) Patients who deny contraception during this study. 11) Any other cases that the attending doctor judges not appropriate to enroll to this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method MTD, DLT and adverse effects.
- Secondary Outcome Measures
Name Time Method Immune response