Clinical trial · Interventional
CASIMAS: Catumaxomab Safety Phase IIIb Study With Intraperitoneal Infusion in Patients With Malignant Ascites Due to Epithelial Cancers
Two-arm, Randomized, Open-label, Phase IIIb Study Investigating the Safety of a 3 Hour i.p. Infusion of Catumaxomab With and Without Prednisolone Premedication in Patients With Malignant Ascites Due to Epithelial Cancer
- 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)
This is a randomized phase IIIb study investigating the treatment of malignant ascites due to epithelial cancer (carcinomas) with the trifunctional antibody catumaxomab. In order to make the catumaxomab treatment more convenient for the patient and the hospital praxis the tolerability of 3 hour infusions of catumaxomab with and without premedication of prednisolone is evaluated. A total of 208 patients with malignant ascites due to epithelial cancer will be allocated to two treatment groups in a 1:1 ratio.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Carcinoma | Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Malignant Ascites | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Catumaxomab | Drug | Catumaxomab | ALIAS |
| Prednisolone | Drug | Prednisolone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- description
- Patients will receive premedication of 25 mg (i.v.) prednisolone 30 minutes prior start of infusion of catumaxomab. Catumaxomab will be infused i.p. with 3 hour constant rate infusions via an indwelling catheter.
- interventionNames
- Drug: Catumaxomab
- Drug: Prednisolone
- type
- OTHER
- label
- B
- description
- Catumaxomab will be administered in a dosage identical to Arm A but without the prednisolone premedication.
- interventionNames
- Drug: Catumaxomab
Primary outcomes (2)
- measure
- Influence of prednisolone on the safety of 3 hours i.p. infusion of catumaxomab measured by a composite safety score
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: 1. Patients with malignant ascites requiring therapeutic ascites puncture 2. Histological confirmed diagnosis of epithelial cancer 3. Patients where standard therapy is not available or no longer feasible 4. Karnofsky index ≥60 % 5. Life expectancy \>12 weeks Key Exclusion Criteria: 1. Concomitant treatment with other investigational product, chemo-, or radiotherapy 2. Recent exposure to an investigational product 3. Known or suspected hypersensitivity to catumaxomab or similar antibodies 4. Inadequate respiratory, renal or hepatic function 5. Inadequate blood count (platelets, neutrophils) 6. Required entirely parenteral nutrition 7. Patients with ileus or subileus within the last 30 days 8. Liver metastases with volume \>70 % of liver tissue 9. Known portal vein obstruction 10. Known Brain metastases 11. Acute or chronic infection 12. Not sufficiently recovered from previous treatment (toxicity present) based on laboratory values and general status 13. Albumin lower than 3 g/dL or total protein \< 6g/dL
References
Publications (4)
- BACKGROUNDLordick F, Ott K, Weitz J, Jager D. The evolving role of catumaxomab in gastric cancer. Expert Opin Biol Ther. 2008 Sep;8(9):1407-15. doi: 10.1517/14712598.8.9.1407. PMID 18694358
- BACKGROUNDBurges A, Wimberger P, Kumper C, Gorbounova V, Sommer H, Schmalfeldt B, Pfisterer J, Lichinitser M, Makhson A, Moiseyenko V, Lahr A, Schulze E, Jager M, Strohlein MA, Heiss MM, Gottwald T, Lindhofer H, Kimmig R. Effective relief of malignant ascites in patients with advanced ovarian cancer by a trifunctional anti-EpCAM x anti-CD3 antibody: a phase I/II study. Clin Cancer Res. 2007 Jul 1;13(13):3899-905. doi: 10.1158/1078-0432.CCR-06-2769. PMID 17606723
- BACKGROUNDShen J, Zhu Z. Catumaxomab, a rat/murine hybrid trifunctional bispecific monoclonal antibody for the treatment of cancer. Curr Opin Mol Ther. 2008 Jun;10(3):273-84. PMID 18535935
- DERIVEDFossati M, Buzzonetti A, Monego G, Catzola V, Scambia G, Fattorossi A, Battaglia A. Immunological changes in the ascites of cancer patients after intraperitoneal administration of the bispecific antibody catumaxomab (anti-EpCAMxanti-CD3). Gynecol Oncol. 2015 Aug;138(2):343-51. doi: 10.1016/j.ygyno.2015.06.003. Epub 2015 Jun 3. PMID 26049121