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Also known as AMG 655
Conatumumab · 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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Conatumumab is an investigational monoclonal antibody developed by Amgen Inc. for the treatment of advanced solid tumors. It is an agonist antibody directed at TNFRSF10B. It has been studied in a Phase 2 clinical program and is not an approved therapy.
Conatumumab targets TNFRSF10B, also known as death receptor 5, and acts as an agonist at that receptor. By binding and activating TNFRSF10B, the antibody is designed to trigger apoptotic signaling in tumor cells. This mechanism places it in the agonist antibody class.
Conatumumab is developed by Amgen Inc., which trades on the Nasdaq under the ticker AMGN. Amgen sponsored the clinical program evaluating the antibody in advanced solid tumors.
Conatumumab is in Phase 2 development. It is an investigational agent and has not been approved by the FDA. The Phase 2 program includes one completed trial, and no trials are currently active.
Conatumumab has been evaluated in the completed Phase 2 trial NCT01327612, titled an open label extension study of conatumumab and ganitumab (AMG 479). That trial enrolled 12 participants across the United States, Poland, and Spain and studied advanced solid tumors, including carcinoid, colorectal cancer, lymphoma, non-small cell lung cancer, and sarcoma.
Conatumumab was studied for advanced solid tumors, including carcinoid, colorectal cancer, locally advanced disease, lymphoma, metastatic cancer, non-small cell lung cancer, sarcoma, and other solid tumors. It remains investigational, and its Phase 2 trial in these conditions has been completed.