Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AMG 479
ganitumab · 2 trials · 8 indications
Objective response rate is the percentage of patients achieving partial response (PR) or complete response (CR) per RECIST 1.0 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. CR or PR status must be confirmed by repeat assessments performed no fewer than 4 weeks or more than 6 weeks after the response criteria are first met. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.
| Arm | Type | Description |
|---|---|---|
| AMG 479 | EXPERIMENTAL | Patients receive AMG 479 at a dose of 18 mg/kg administered IV on day 1 (± 3 days) of every 3-week cycle. Treatment should continue until disease progression, unacceptable toxicity or withdrawal of consent. |
| Name | Type | Description |
|---|---|---|
| AMG 479 | DRUG | - |
| ganitumab | BIOLOGICAL | - |
| laboratory biomarker analysis | OTHER | - |
| pharmacological study | OTHER | - |
| biopsy | PROCEDURE | - |
Inclusion Criteria: * Locally unresectable or metastatic carcinoid or pancreatic neuroendocrine tumors. To be classified as having a pancreatic neuroendocrine tumor, patients must have clinical evidence of currently having or having had a primary pancreatic neuroendocrine lesion. * Measurable disea...
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Ganitumab is an investigational monoclonal antibody being studied in oncology, specifically in lymphoma. It has been evaluated in a Phase 1 trial in patients with advanced solid tumors or non-Hodgkin lymphoma. It is not approved for any indication and remains in clinical development.
Ganitumab targets IGF1R, the insulin-like growth factor 1 receptor. It acts as an antagonist, meaning it binds to and blocks the receptor. IGF1R is a cell-surface receptor involved in signaling pathways that can promote tumor cell growth and survival.
Ganitumab is being developed by Amgen Inc., which trades on Nasdaq under the ticker AMGN. Amgen is the sponsor of the clinical program evaluating ganitumab in oncology indications.
Ganitumab is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA for any indication. The Phase 1 program has completed, with no active trials currently listed.
Ganitumab has been studied in one completed Phase 1 trial, NCT00562380, titled AMG-479 in Treating Patients With Advanced Solid Tumors or Non-Hodgkin Lymphoma. The trial enrolled 64 patients in the United States and evaluated ganitumab in lymphoma and advanced solid tumors.