Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MB07133/m2/day · 1 trial · 1 indication
To determine the dose-limiting toxicities (DLT) of MB07133; To determine the maximum-tolerated continuous infusion dose (MTD) of MB07133
| Arm | Type | Description |
|---|---|---|
| MB07133 Dose Level 1 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 2 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 3 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 4 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| MB07133 Dose Level 5 | EXPERIMENTAL | 7-day continuous infusion in 28-day cycles |
| Name | Type | Description |
|---|---|---|
| MB07133 300mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 600 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 1200 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 1800 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
| MB07133 2400 mg/m2/day | DRUG | 7-day continuous infusion in 28-day cycles |
Inclusion Criteria: * Patients with a diagnosis of local unresectable HCC confirmed by histology using fine needle aspirate (FNA) or liver biopsy. "Local" is defined as disease either restricted to the liver or contiguous with the liver and no identifiable extrahepatic disease. * Patients with Chil...
MB07133/m2/day refers to a body surface area based dosing level of MB07133, an investigational small molecule studied in adults with unresectable hepatocellular carcinoma. The Phase 1 trial evaluated intravenous infusion of MB07133 in patients with this form of liver cancer across sites in the United States, Hong Kong, and Taiwan.
MB07133 is being developed by Ligand Pharmaceuticals Incorporated, which trades on the Nasdaq under the ticker LGND. The company sponsored the Phase 1 study of the agent in unresectable hepatocellular carcinoma.
MB07133 is in Phase 1 clinical development. Its single registered trial, NCT00073736, was a Phase 1 study of intravenous MB07133 in patients with unresectable hepatocellular carcinoma. That trial is now completed, and MB07133 is an investigational agent rather than an approved therapy.
MB07133 has been studied in one registered clinical trial, NCT00073736, titled Safety and Tolerability of I.V. Infusion of MB07133 in Patients With Unresectable Hepatocellular Carcinoma. The Phase 1 trial enrolled 28 adults aged 18 years and older, was controlled, and has been completed.