Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AMG 655 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | AMG 655 10 mg/kg plus AMG 479 placebo in combination with FOLFIRI every 14 days |
| Arm C | ACTIVE_COMPARATOR | AMG 479 Placebo plus AMG 655 Placebo in combination with FOLFIRI every 14 days |
| Arm B | EXPERIMENTAL | AMG 479 12 mg/kg plus AMG 655 placebo in combination with FOLFIRI every 14 days |
| Name | Type | Description |
|---|---|---|
| FOLFIRI | OTHER | Day 1 of each Cycle Combination Therapy of: irinotecan 180 mg/m2 90-minute infusion leucovorin 400 mg/m2 2 hour infusion 5-FU 400 mg/m2 IV bolus 5-FU 2,400 mg/m2 46-48 hour infusion |
| AMG 655 | BIOLOGICAL | AMG 655 is an investigational, fully human, monoclonal antibody that selectively binds to Death Receptor-5 (DR-5) |
| Placebo | OTHER | Inactive dummy agent (to maintain blind) |
| AMG 479 | BIOLOGICAL | AMG 479 is an investigational, fully human, monoclonal antibody that binds with Insulin-like growth factor receptor type 1 |
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 Exclusi...
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AMG 655 is a monoclonal antibody being developed for metastatic colorectal cancer. It is currently in Phase 2 clinical development. The drug is being studied in patients with KRAS-mutant metastatic colorectal carcinoma, a specific genetic subtype of the disease.
AMG 655 is being developed by ImmunityBio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol IBRX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with metastatic colorectal cancer.
AMG 655 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 2 trial for metastatic colorectal cancer, with results expected to inform further development.
AMG 655 has been studied in one completed Phase 2 clinical trial, identified as NCT00813605. The trial, titled QUILT-2.018, evaluated the safety and efficacy of FOLFIRI with AMG 655 compared to FOLFIRI alone in patients with KRAS-mutant metastatic colorectal carcinoma.
No, AMG 655 and AMG 479 are different drugs. In the clinical trial NCT00813605, both drugs were studied separately in combination with FOLFIRI chemotherapy, each compared against FOLFIRI alone, in patients with KRAS-mutant metastatic colorectal cancer. AMG 655 is a monoclonal antibody.
QUILT-2.018 is a Phase 2 clinical trial with the identifier NCT00813605. It was a randomized, double-blind, active-controlled study that enrolled 155 patients with KRAS-mutant metastatic colorectal cancer. The trial compared FOLFIRI plus AMG 655 against FOLFIRI alone and has been completed.