Clinical trial · Interventional
Phase 1b/2 Study of AMG 655 With mFOLFOX6 and Bevacizumab for First-Line Metastatic Colorectal Cancer
A Phase 1b/2 Study of AMG 655 in Combination With Modified FOLFOX6 and Bevacizumab for the First-Line Treatment of Subjects With Metastatic Colorectal 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 phase 1/2, multi-center, randomized, double-blind, placebo-controlled trial is designed to evaluate the efficacy and safety of AMG 655 when combined with mFOLFOX6 and bevacizumab compared with mFOLFOX6 and bevacizumab alone in subjects with previously untreated metastatic colorectal cancer (CRC). The clinical benefit of AMG 655 in combination with mFOLFOX6 and bevacizumab will be measured by progression-free survival, objective response rate, time to response, duration of response, and overall survival. This study is also designed to evaluate the safety and tolerability of AMG 655 in combination with mFOLFOX6 and bevacizumab and to evaluate anti-AMG 655 antibody formation and the pharmacokinetics of AMG 655.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 655 | Drug | Conatumumab | ALIAS |
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Modified FOLFOX6 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- AMG 655 Low Dose
- description
- AMG 655 (low dose) + mFOLFOX6 + Bevacizumab
- interventionNames
- Drug: AMG 655
- Drug: Modified FOLFOX6
- Drug: Bevacizumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo + mFOLFOX6 + Bevacizumab
- interventionNames
- Drug: Placebo
- Drug: Modified FOLFOX6
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- AMG 655 High Dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed metastatic adenocarcinoma of the colon or rectum. * Subjects with measurable or unmeasurable disease * Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 * Men or women at least 18 years of age * Adequate hematologic, renal, hepatic and coagulation function Exclusion Criteria: * History or known presence of central nervous system (CNS) metastases * Prior chemotherapy or other systemic therapy for advanced or metastatic CRC * Any investigational agent or therapy for advanced or metastatic CRC * Clinically significant cardiac disease * Clinically significant peripheral neuropathy * Active inflammatory bowel disease * Recent gastrointestinal ulcer or hemorrhage * Recent arterial thrombotic event or pulmonary embolus * Recent history of clinically significant bleeding, bleeding diathesis, or coagulopathy * Recent major surgical procedure or not yet recovered from major surgery
References
Publications (1)
- BACKGROUNDFuchs CS, Fakih M, Schwartzberg L, Cohn AL, Yee L, Dreisbach L, Kozloff MF, Hei YJ, Galimi F, Pan Y, Haddad V, Hsu CP, Sabin A, Saltz L. TRAIL receptor agonist conatumumab with modified FOLFOX6 plus bevacizumab for first-line treatment of metastatic colorectal cancer: A randomized phase 1b/2 trial. Cancer. 2013 Dec 15;119(24):4290-8. doi: 10.1002/cncr.28353. Epub 2013 Oct 1. PMID 24122767