Clinical trial · Interventional
Phase I/II Study of KRN330 Plus Irinotecan in Patients With Metastatic Colorectal Cancer
Phase I/II Study of KRN330 Plus Irinotecan After First-Line or Adjuvant FOLFOX/CapOx Failure in Patients With Metastatic Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per protocol, the study was terminated based on interim analysis results
Summary
Brief summary (as posted)
The primary objective of the Phase II portion of this study is to assess the efficacy of KRN330 in combination with irinotecan after first-line or adjuvant FOLFOX (5-fluorouracil, leucovorin, and oxaliplatin)/CapOx (capecitabine and oxaliplatin) treatment failure in patients with metastatic 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Irinotecan | Drug | Irinotecan | ALIAS |
| KRN330 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- KRN330 + Irinotecan
- description
- open label, single arm
- interventionNames
- Biological: KRN330
- Drug: Irinotecan
Primary outcomes (1)
- measure
- Number of Participants With Serious and Other (Non-Serious) Adverse Events According to the CTCAE v.3.0
- timeFrame
- Until disease progression, death, or withdrawal post initial KRN330 treatment, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have histologically confirmed colorectal cancer that is metastatic with measurable disease. * For the Phase II portion: Have recurred or progressed within 6 months of the last cycle of FOLFOX +/- bevacizumab first-line or adjuvant regimen for metastatic colorectal cancer. Note: Those who had initiated FOLFOX/CapOx but stopped oxaliplatin because of intolerable toxicity are also eligible. * At least 4 weeks have elapsed since the last chemotherapy, radiotherapy, immunotherapy, or biologic therapy prior to enrollment (except at least 6 weeks in the case of nitrosourea and mitomycin). * Have not received any other investigational agents within 4 weeks of study entry and have fully recovered from any adverse event due to prior therapy. * At least 4 weeks have elapsed since any major surgery. * Have ECOG performance status of 0, 1, or 2. * Have adequate bone marrow and organ function Exclusion Criteria: * Have an active, uncontrolled infection. * Have known HIV positive status. * Have known or suspected cerebral metastasis. * Have had a myocardial infarction (MI) or cerebrovascular accident (CVA) within the last 6 months; or meet the criteria for AHA class III or IV congestive heart failure (CHF). * Have a medical condition requiring chronic use of high-dose corticosteroids or other chronic immunosuppressive therapy (e.g. methotrexate, azathioprine). * Have a history of greater than or equal to Grade 2 allergic reaction or hypersensitivity following exposure to humanized or human monoclonal antibodies (but not chimeric antibodies). * Pregnant or breastfeeding women and male or female patients who do not agree to use effective contraceptive method(s) during the study.
References
Publications (0)
Data not yet available