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IMF-001 Phase 1 Study With Refractory Esophageal Tumor

Phase 1
20 Years
Not Enrolling
Esophageal Cancer

Thank you

Trial Information

IMF-001 Phase 1 Study With Refractory Esophageal Tumor

The prognosis of esophageal cancer is improved with the improvement of surgery, chemotherapy
and radiation therapy. However, there are no standard therapies established for recurrent
esophageal cancer. NY-ESO-1 antigen is expressed in 33% of patients. NY-ESO-1 protein is
applicable without limitation by HLA types, and injected as a complex with cholesteryl
pullulan (CHP), forming nano-particles (IMF-001), it can activate both CD4+ and CD8+ T
cells. In this phase 1 study, the safety and the biological recommended dose will be

Inclusion Criteria:

- Radically unresectable stage III/IV esophageal tumors that have failed the standard
treatment (including chemotherapy and radiotherapy), recurrent metastasis after
radical surgery and not responding to the standard treatments, or recurrent
metastasis after radiotherapy before/after radical surgery.

- Primary esophageal tumors confirmed by pathological diagnosis

- Tumor cells expressing NY-ESO-1 antigen (by tissue-immunostaining method or
quantitative RT-PCR method)

- Performance status (PS) of 0, 1 or 2 (ECOG Scale)

- Life expectancy >/= 4 months

- No serious disorders with major organs (bone marrow, heart, lung, liver and kidney)
and meets the following criteria:

- WBC count >/= 2.0 x 10 9/L

- Hemoglobin >/=8.0g/dL

- Platelet count >/=75 x 10 9/L

- Serum total bilirubin:
- AST and ALT:
- Serum creatinine:
- Agree to use birth control including condoms from the time of obtaining the consent
to 6 months after the final administration of the study drug [except females after
menopause (1 year or more after the last menstruation and females/males after an
operation for sterilization)]

- Given written informed consent

Exclusion Criteria:

- HIV antibody positive

- Double cancer

- History of autoimmune disease

- History of severe anaphylaxis

- Active metastatic disease in the central nervous system (CNS) Within 4 weeks after
treatment with an anti-tumor agent, systemically administered adrenocorticosteroids,
immune suppressants or immune enhancers

- Pregnant or lactating

- Any other inadequacy for this study

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the maximum tolerated dose, dose-limiting toxicities, type/frequency/degree of adverse events and NY-ESO-1 antigen-specific immune response of IMF-001 alone in patients with esophageal cancer.

Outcome Time Frame:

First 12 weeks (during the first 6 injections)

Safety Issue:


Principal Investigator

Daiju Ichimaru, BSc

Investigator Role:

Study Director

Investigator Affiliation:

ImmunoFrontier, Inc.


Japan: Pharmaceuticals and Medical Devices Agency

Study ID:




Start Date:

November 2009

Completion Date:

December 2012

Related Keywords:

  • Esophageal Cancer
  • Esophageal Diseases
  • Esophageal Neoplasms