Clinical trial · Interventional
Study of MOC31-PE in Antigen Positive Carcinomas
Phase I Study of MOC31-PE in Antigen Positive Carcinomas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MOC31-PE | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MOC31-PE
- interventionNames
- Drug: MOC31-PE
Primary outcomes (2)
- measure
- The documentation of the Maximum Tolerated Dose (MID)
- timeFrame
- 2 years
- measure
- The identification of the dose limiting toxicity (DLT)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available