Clinical trial · Interventional
A Study of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Subjects With Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
Phase 2 Study Comparing Efficacy and Safety of ABT-165 Plus FOLFIRI vs Bevacizumab Plus FOLFIRI in Metastatic Colorectal Cancer Previously Treated With Fluoropyrimidine, Oxaliplatin and Bevacizumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study may continue
Summary
Brief summary (as posted)
A study to evaluate the efficacy and tolerability of ABT-165 plus FOLFIRI compared to bevacizumab plus FOLFIRI in participants with previously treated metastatic adenocarcinoma of the colon or rectum.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-165 | Drug | — | UNRESOLVED |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Fluorouracil - bolus | Drug | — | UNRESOLVED |
| Fluorouracil - infusion | Drug | Fluorouracil | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Leucovorin | Drug | Leucovorin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ABT-165 plus FOLFIRI
- description
- ABT-165 plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
- interventionNames
- Drug: Leucovorin
- Drug: Fluorouracil - bolus
- Drug: Fluorouracil - infusion
- Drug: ABT-165
- Drug: Irinotecan
- type
- ACTIVE_COMPARATOR
- label
- Bevacizumab plus FOLFIRI
- description
- Bevacizumab plus FOLFIRI (irinotecan, leucovorin, fluorouracil).
- interventionNames
- Drug: Leucovorin
- Drug: Fluorouracil - bolus
- Drug: Bevacizumab
- Drug: Fluorouracil - infusion
- Drug: Irinotecan
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum. * Primary tumor has been resected \> 3 months prior to randomization. * At least 1 lesion on a computed tomography (CT) scan (preferred) or magnetic resonance imaging (MRI) that is measurable as defined by Response Evaluation Criteria In Solid Tumors (RECIST), Version 1.1. * Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. * Progression following treatment with fluoropyrimidine/oxaliplatin/bevacizumab-regimen in the metastatic setting. * Adequate hematologic, renal and hepatic function. Exclusion Criteria: * Any prior therapy with irinotecan * Unresolved clinically significant toxicities from prior anticancer therapy, defined as any Common Terminology Criteria for Adverse Events (CTCAE) =\> Grade 2 * Clinically significant conditions that increase the risk for antiangiogenic therapy. * History of any of the following during first-line therapy with a bevacizumab-containing regimen: arterial thrombotic/thromboembolic event, bowel perforation, Grade 4 hypertension, Grade 3 proteinuria or Grade 3 - 4 bleeding event.
References
Publications (1)
- DERIVEDStrickler JH, Cubillo A, Liang JT, Matrana M, Kozloff M, Lowe T, Blaney M, Sahtout M, Naumovski L, Wainberg ZA. Efficacy and safety of dilpacimab (ABT-165) versus bevacizumab plus FOLFIRI in metastatic colorectal cancer: a phase II study. Future Oncol. 2022 Sep;18(27):3011-3020. doi: 10.2217/fon-2021-1603. Epub 2022 Aug 3. PMID 35920133