Clinical trial · Interventional
QUILT-2.018: Safety & Efficacy of FOLFIRI With AMG 479 or AMG 655 vs FOLFIRI Alone in KRAS-mutant Metastatic Colorectal Carcinoma
A Phase 2, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety and Efficacy of FOLFIRI in Combination With AMG 479 or AMG 655 Versus FOLFIRI for the Second-line Treatment of KRAS-mutant Metastatic Colorectal Carcinoma
- 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 phase 2, multicenter, randomized, double-blind, double-dummy, placebo-controlled, three-arm trial to be conducted in the United States, Europe, and Asia. Approximately 150 eligible KRAS-mutant metastatic colorectal cancer subjects who have failed first line fluoropyrimidine and oxaliplatin-based regimen with or without anti-VEGF therapy will be randomized in a 1:1:1 ratio to receive AMG 479 placebo plus AMG 655 with FOLFIRI, or AMG 479 plus AMG 655 placebo with FOLFIRI, or AMG 479 placebo plus AMG 655 placebo with FOLFIRI
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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AMG 479 | Biological | Ganitumab | ALIAS |
| AMG 655 | Biological | Conatumumab | ALIAS |
| FOLFIRI | Other | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days
- interventionNames
- Other: FOLFIRI
- Biological: AMG 655
- Other: Placebo
- type
- ACTIVE_COMPARATOR
- label
- Arm C
- description
- AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days
- interventionNames
- Other: FOLFIRI
- Other: Placebo
- type
- EXPERIMENTAL
- label
- Arm B
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of colon or rectum in patients with metastatic disease * Mutant-type KRAS tumor at screening * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1 * Adequate hematology, renal, hepatic, and coagulation function Exclusion Criteria: * History or known presence of central nervous system metastases * History of other malignancy * Prior irinotecan-based chemotherapy for advanced/metastatic disease * Prior death receptor agonists, or other systemic IGF-1R agonists in any setting * Uncontrolled cardiovascular disease
References
Publications (0)
Data not yet available