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 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 I study on the combination therapy of IMF-001 and MIS416 for the treatment of patients with NY-ESO-1 expressing malignant solid tumor.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008007

Enrollment

Registered

2012-05-21

Start date

2012-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant solid tumor

Interventions

IMF-001, MIS416

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Pathologically confirmed malignant solid tumor. 2) Refractory to standard therapies. 3) NY-ESO-1 expression in tumor confirmed by immunohistochemistry or RT-PCR. 4) Life expectancy: >= 3 months from the date of consent. 5) Age: >= 20 years old. 6) Performance status (PS, ECOG scale): 0-2. 7) Adequate organ functions, measured as follows: White blood cells: >= 2,000/mm3 Hemoglobin: >= 8.0g/dl Platelet: >= 75,000/mm3 Total birilbin: <= 1.5 x ULN AST (GOT): <= 3.0 x ULN ALT (GPT): <= 3.0 x ULN Serum creatinine: <= 1.5 x ULN 8) >= 4 weeks from prior therapy at start of this treatment. 9) Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
MTD, DLT and adverse effects.	—

Secondary

Measure	Time frame
Immune response	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026