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Study of MOC31-PE in Antigen Positive Carcinomas

University of Oslo (UIO) logo

University of Oslo (UIO)

Status and phase

Completed
Phase 1

Conditions

Carcinoma

Treatments

Drug: MOC31-PE

Study type

Interventional

Funder types

Other

Identifiers

NCT01061645
MOC31-PE

Details and patient eligibility

About

Immunotoxins (ITs), monoclonal antibodies conjugated to plant or bacterial toxins, have been extensively investigated for their possible use as anti-tumor agents although not in carcinoma patients with minimal residual disease. Various ITs have been tested in early clinical trials and recent studies demonstrate anti-tumor activity of IT treatment in patients with glioblastoma and different solid tumors. Systemic treatment with immunotoxins directed against carefully selected epithelial cell surface molecules may have a potential for eradicating also dormant metastatic tumor cells, as their action is independent of cell proliferation. The effector moieties of the IT used here, the Pseudomonas exotoxin A (PE), inhibits protein synthesis in eukaryotic cells by catalytic inactivation (ribosylation) of elongation factor 2 in the ribosome complex.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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 below.
  • 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

MOC31-PE
Experimental group
Treatment:
Drug: MOC31-PE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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