Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Conatumumab
AMG 655 · 2 trials · 4 indications
The incidence of adverse events and clinical laboratory abnormalities defined as DLTs. A DLT was defined as any grade 3 or higher hematologic or non-hematologic toxicity related to any study treatment.
The proportion of subjects alive at 6 months
| 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 |
| Phase 1b AMG 655 3mg/kg | EXPERIMENTAL | Subjects were treated with one of 2 dose levels of AMG 655 (3 mg/kg) with gemcitabine. |
| Phase 1b AMG 655 10mg/kg | EXPERIMENTAL | Subjects were treated with one of 2 dose levels of AMG 655 (10 mg/kg) with gemcitabine. |
| Phase 2 AMG 655 | EXPERIMENTAL | Subjects were treated with the dose of AMG 655 (10mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655 infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Phase 2 AMG 479 | EXPERIMENTAL | Subjects were treated with the dose of AMG 479 (12 mg/kg) in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 479 infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| Phase 2 AMG 655-placebo | PLACEBO_COMPARATOR | Subjects were treated with the dose of AMG 655-placebo in combination with gemcitabine. Gemcitabine (1000 mg/m2) was administered by intravenous infusion on days 1, 8 and 15 of each 28 day cycle followed by the AMG 655-placebo infusion on days 1 and 15 after completion of the gemcitabine infusion. |
| 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 was studied in oncology for the treatment of adenocarcinoma of the pancreas and metastatic colorectal cancer. It was evaluated in combination regimens rather than as a single agent, including with gemcitabine in metastatic pancreatic cancer and with FOLFIRI in KRAS-mutant metastatic colorectal carcinoma.
AMG 655 is being developed by ImmunityBio, Inc., which trades under the ticker IBRX. The company is the sponsor associated with the clinical program for this small molecule oncology candidate.
AMG 655 is in Phase 1 development and is investigational. It has not been established as an approved therapy. One completed Phase 1 trial, NCT00630552, evaluated AMG 655 with gemcitabine in metastatic pancreatic cancer, and a completed Phase 2 trial, NCT00813605, studied it in metastatic colorectal cancer.
AMG 655 has been studied in two completed trials. NCT00813605, known as QUILT-2.018, was a randomized, double-blind, placebo-controlled Phase 2 study of FOLFIRI with AMG 479 or AMG 655 versus FOLFIRI alone in KRAS-mutant metastatic colorectal carcinoma, enrolling 155 patients across the United States, Europe and Asia. NCT00630552, QUILT-2.019, was a Phase 1 study of AMG 655 or AMG 479 with gemcitabine in metastatic pancreatic cancer, enrolling 138 patients in the United States.
The AMG 655 clinical program enrolled 155 patients in the Phase 2 colorectal cancer trial NCT00813605 and 138 patients in the Phase 1 pancreatic cancer trial NCT00630552. Both studies are listed as completed, and no trials are currently active.
Yes. The Phase 2 trial NCT00813605, QUILT-2.018, was randomized, double-blind and placebo-controlled, comparing FOLFIRI plus AMG 479 or AMG 655 against FOLFIRI alone in patients with KRAS-mutant metastatic colorectal carcinoma. It enrolled 155 patients and has been completed.