Clinical trial · Interventional
Zalutumumab With or Without Irinotecan Chemotherapy in Cetuximab-Refractory Colorectal Cancer
A Dose-Escalation, Randomized Phase I/II Trial of Zalutumumab - a Human Monoclonal Anti-EGF Receptor Antibody - With or Without Irinotecan Chemotherapy in Cetuximab Refractory Colorectal Cancer Patients Who Have Failed Standard Chemotherapy and Progressed During or Within 3 Months of Stopping Cetuximab-Based Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to changes in portfolio review
Summary
Brief summary (as posted)
The purpose of this trial is to determine the safety and efficacy of Zalutumumab alone or in combination with Irinotecan for the treatment of patients with Colorectal Cancer
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zalutumumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Zalutumumab 8 mg/kg
- description
- Zalutumumab in combination with Irinotecan
- interventionNames
- Drug: Zalutumumab
- type
- EXPERIMENTAL
- label
- Zalutumumab 16 mg/kg
- description
- Zalutumumab in combination with Irinotecan
- interventionNames
- Drug: Zalutumumab
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events (AEs)
- timeFrame
- From first dose up to follow-up (up to approximately 1 year)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Males and Females age ≥ 18 years 2. Confirmed diagnosis of CRC 3. Documented disease progression 4. Failure and/or intolerance to standard chemotherapy Exclusion Criteria: 1. Prior treatment with anti-EGFR antibodies other than cetuximab 2. Expected survival \< 3 months 3. Clinical significant cardiac disease and/or uncontrolled medical conditions
References
Publications (1)
- RESULTMano M, Hendlisz A, Machiels JP, Ehrnrooth E, Aladdin H, Van Laethem JL. Phase I trial of zalutumumab and irinotecan in metastatic colorectal cancer patients who have failed irinotecan and cetuximab based therapy. J Clin Oncol 27 2009 (suppl;abstr e15028)