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Also known as Conatumumab
AMG 655 · 5 trials · 19 indications
An adverse event is defined as any untoward medical occurrence in a clinical trial participant, including worsening of a pre-existing medical condition. The event does not necessarily have a causal relationship with study treatment.
A serious adverse event is defined as an adverse event that met at least 1 of the following serious criteria: * fatal, * life threatening (places the participant at immediate risk of death), * required in-patient hospitalization or prolongation of existing hospitalization, * resulted in persistent or significant disability/incapacity, * congenital anomaly/birth defect, and/or * other medically important serious event.
| Arm | Type | Description |
|---|---|---|
| Conatumumab Monotherapy | EXPERIMENTAL | Participants will continue to receive conatumumab every 2 weeks (Q2W) or every 3 weeks (Q3W) at the same dose and regimen as at the conclusion of the parent study. |
| Conatumumab + Ganitumab | EXPERIMENTAL | Participants will receive conatumumab and ganitumab by intravenous infusion at the same dose and regimen as at the conclusion of the parent study. |
| Ganitumab Monotherapy | EXPERIMENTAL | Participants will continue to receive ganitumab Q3W or every 4 weeks (Q4W) at the same dose and regimen as at the conclusion of the parent study. |
| Conatumumab + mFOLFOX6 ± Bevacizumab | EXPERIMENTAL | Participants will continue to receive conatumumab by intravenous infusion in addition to modified FOLFOX6 chemotherapy with or without bevacizumab. |
| Cohort 4 | EXPERIMENTAL | AMG 655 (intermediate dose) with Vorinostat |
| Cohort 1 | EXPERIMENTAL | AMG 655 (low dose) with Bortezomib |
| Cohort 2 | EXPERIMENTAL | AMG 655 (low dose) with vorinostat |
| Cohort 5 | EXPERIMENTAL | AMG 655 (high dose) with Bortezomib |
| Cohort 6 | EXPERIMENTAL | AMG 655 (high dose) with Vorinostat |
| Cohort 7 | EXPERIMENTAL | Part 2 - Mantle Cell Lymphoma subjects only: AMG 655 at dose TBD with Bortezomib |
| Cohort 3 | EXPERIMENTAL | AMG 655 (intermediate dose) with Bortezomib |
| Arm 2 | EXPERIMENTAL | Low Dose AMG 655 with paclitaxel/carboplatin |
| Arm 3 | PLACEBO_COMPARATOR | Placebo with paclitaxel/carboplatin |
| Arm 1 | EXPERIMENTAL | AMG 655 High doseplus paclitaxel/carboplatin |
| AMG 655 Low Dose | EXPERIMENTAL | AMG 655 (low dose) + mFOLFOX6 + Bevacizumab |
| Placebo | PLACEBO_COMPARATOR | Placebo + mFOLFOX6 + Bevacizumab |
| AMG 655 High Dose | EXPERIMENTAL | AMG 655 (high dose) + mFOLFOX6 + Bevacizumab |
| Name | Type | Description |
|---|---|---|
| Modified FOLFOX6 | DRUG | The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days. |
| Conatumumab | BIOLOGICAL | Administered by intravenous infusion Q2W or Q3W. |
| Ganitumab | BIOLOGICAL | Administered by intravenous infusion Q3W or Q4W. |
| Bevacizumab | BIOLOGICAL | Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle. |
| AMG 655 | DRUG | AMG 655 is an investigational, fully human monoclonal agonist antibidy that selectively binds to Death Receptor-5 (DR-5). |
| Vorinostat | OTHER | Vorinostat, a second generation polarplanar compound, binds to the catalytic domain of the histone deacetylases (HDAC). |
| Bortezomib | OTHER | A dipeptide boronic acid analogue with antineoplastic activity. |
| AMG 655 placebo | OTHER | Inactive dummy AMG 655 (to maintain blind) |
| Placebo | OTHER | Inactive dummy AMG 655 (to maintain blind) |
| Doxorubicin | DRUG | Antineoplastic antibiotic obtained from Streptomyces peucetius. It is a hydroxy derivative of Daunorubicin. |
Inclusion Criteria: * To be enrolled in this study, subjects must be currently enrolled in a prior Amgen-sponsored conatumumab or AMG 479 study and are eligible according to the parent study to receive their next dose of conatumumab (with or without co-therapy), or AMG 479 alone. Subjects must hav...
AMG 655 is an investigational small molecule being studied for the treatment of several cancers, including metastatic colorectal cancer, non-small cell lung cancer, Hodgkin's lymphoma, and locally advanced or metastatic unresectable soft tissue sarcoma. It is being evaluated in combination with other therapies in clinical trials.
AMG 655 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical development for oncology indications.
AMG 655 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. All completed trials for AMG 655 were Phase 1 studies, and no active trials are currently listed.
AMG 655 has been studied in several completed Phase 1 trials. These include NCT00534027 for non-small cell lung cancer, NCT00625651 for metastatic colorectal cancer, NCT00626704 for unresectable soft tissue sarcoma, and NCT00791011 for lymphoma, including Hodgkin's lymphoma.
Yes, AMG 655 has been studied in combination with other cancer therapies. Trials include AMG 655 with paclitaxel and carboplatin for lung cancer, with mFOLFOX6 and bevacizumab for colorectal cancer, with doxorubicin for soft tissue sarcoma, and with bortezomib or vorinostat for lymphoma.