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Phase I Study of MOC31-PE in Antigen Positive Carcinomas

Phase 1
18 Years
75 Years
Not Enrolling

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Trial Information

Phase I Study of MOC31-PE in Antigen Positive Carcinomas

Inclusion Criteria:

- Histologically confirm epithelial carcinoma, verified to be positive for the
targeting antigen(Ep-CAM/epithelial glyco protein 2)according to the criteria given

- Tumor specimens verified to be positive for the targeting antibody,i.e.EGP2 positive
(MOC31) by immunocytochemical or histochemical staining.

- Signed written informed consent

- Patients with no clinically symptomatic central nervous system (CNS) involvement.

- Both gender, age 18 -75 years old.

- Life expectancy of at least 3 months

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- Adequate hematologic, renal and hepatic function defined as: Neutrophils > 1.5 x
10^9/L;Platelets > 100 x 10^9/L; Creatinine < 120 umol/L; Total bilirubin within
normal range. Liver enzymes (ALAT and ASAT <2.5 UNL: alkaline phosphatase < 1.5 UNL
and yGT < 1.5 UNL).

- Coagulation parameters (pT, PTT) within normal range.

Exclusion Criteria:

- No medical history of Hepatitis B or C infection

- Patients must have no ECG abnormalities

- Patients must not be HIV positive

- Female premenopausal patients should not be pregnant (must have a negative pregnancy
test prior to inclusion) and should not be lactating.

- Patients must use effective contraception if of reproductive potential.

- Prior chemotherapy and/or radiation should be completed for at least 4 weeks prior to
study enrolment

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The documentation of the Maximum Tolerated Dose (MID)

Outcome Time Frame:

2 years

Safety Issue:



Norway: Norwegian Medicines Agency

Study ID:




Start Date:

September 2010

Completion Date:

February 2012

Related Keywords:

  • Carcinoma
  • MDT and DLT
  • Carcinoma