Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMC-A12- 10 milligrams/kilogram · 1 trial · 1 indication
PFS is defined as the time from date of first dose of study drug until the date of objective PD or death due to any cause, whichever occurs first. PD defined as a ≥20% increase in the sum of the longest diameter (LD) of target lesions using as reference the smallest sum LD since baseline or ≥1 new lesions. Participants who died without PD were considered to have progressed on the date of death. Participants who were alive and without PD were censored at the time of the last objective tumor assessment. Participants who did not progress and are subsequently lost to follow-up were censored at the date of their last objective tumor assessment before loss to follow-up. Participants who progressed or died after ≥2 missed tumor assessment visits were censored at the date of their last objective tumor assessment before missed assessments. Participants who begin a new anticancer therapy were censored at the date of their last objective tumor assessment before initiation of new therapy.
| Arm | Type | Description |
|---|---|---|
| Cohort 1, IMC A12 - 10 mg/kg | ACTIVE_COMPARATOR | Treatment cycles will repeat until there is evidence of progressive disease (PD), toxicity, or withdrawal. If any participant experiences a dose-limiting toxicity (DLT), an additional 3 participants will be enrolled at this dose level (for a total of 6). If no further DLTs, enrollment into Cohort 2 will occur. |
| Cohort 2, IMC A12 20 - mg/kg | ACTIVE_COMPARATOR | Treatment cycles will repeat until there is evidence of PD, toxicity, or withdrawal. |
| Name | Type | Description |
|---|---|---|
| IMC-A12 (cixutumumab) - 10 milligrams/kilogram (mg/kg) | BIOLOGICAL | intravenous infusions 10 mg/kg on Day 1 of each 3-week cycle |
| IMC-A12 (cixutumumab) - 20 mg/kg | BIOLOGICAL | intravenous infusions 20 mg/kg on Day 1 of each 3-week cycle |
| Sorafenib | DRUG | 400 milligrams (mg) twice per day orally |
Inclusion Criteria: * The participant has histologically or cytologically confirmed, unresectable HCC * The participant has at least one target lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesion(s) must not lay within a previously irradiat...
IMC-A12- 10 milligrams/kilogram is an investigational monoclonal antibody studied for hepatocellular carcinoma, a form of liver cancer. It was evaluated in a Phase 2 trial in combination with sorafenib in participants with advanced cancer of the liver. It is not an approved therapy and remains in clinical development.
IMC-A12- 10 milligrams/kilogram is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. The company sponsored the Phase 2 study of the antibody in advanced liver cancer.
IMC-A12- 10 milligrams/kilogram is in Phase 2 development. One Phase 2 trial has been completed, and no trials are currently active. The drug is investigational and has not been approved for any indication.
IMC-A12- 10 milligrams/kilogram was studied in NCT00906373, titled A Study of IMC-A12 in Combination With Sorafenib in Participants With Advanced Cancer of the Liver. The Phase 2 trial enrolled 47 participants in the United States and has been completed.
Yes. IMC-A12- 10 milligrams/kilogram is also known as IMC-A12 (cixutumumab) at a dose of 10 milligrams per kilogram. Cixutumumab is the international nonproprietary name for the same monoclonal antibody.