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Also known as KHK2804
CEP-37250/KHK2804 · 1 trial · 3 indications
The safety of CEP-37250/KHK2804 will be determined by reported adverse events (AEs), changes in the physical examinations, vital laboratory evaluations, and treatment discontinuations due to toxicity.
| Arm | Type | Description |
|---|---|---|
| Part 1 | EXPERIMENTAL | Dose escalation in subjects with advanced solid tumors with Part 1 which includes intervention of CEP-37250/KHK2804 |
| Part 2 | EXPERIMENTAL | Subjects with colorectal or pancreatic cancer Part 2 which includes intervention of CEP-37250/KHK2804 |
| Name | Type | Description |
|---|---|---|
| CEP-37250/KHK2804 | DRUG | Part 1 is based on the CEP-37250/KHK2804 tolerability and safety data from three subjects enrolled in a cohort, enrollment at the next dose level or additional subjects into the ongoing cohort will occur based upon the number subjects with DLT at a given dose level. Dose depends on subject's body weight. Part 1 includes intervention of CEP-37250/KHK2804. Part 2 will receive CEP-37250/KHK2804 at a dose to be determined following completion of Part 1. |
Inclusion Criteria: * Adequate hepatic, renal, and hematologic function; * Life expectancy \> 3 months; * Part 1 and 2: The subject has histopathologically or cytologically documented, measurable, unresectable, locally advanced primary or recurrent, metastatic solid tumor, locally advanced primary ...
CEP-37250/KHK2804 is an investigational small molecule developed by Teva Pharmaceutical Industries Limited for the treatment of advanced solid tumors. It has been studied in a Phase 1 clinical trial that enrolled 71 patients with solid tumors, including colorectal and pancreatic adenocarcinoma. It is not an approved therapy.
CEP-37250/KHK2804 was studied in patients with advanced solid tumors, specifically including adenocarcinoma of the colorectal and adenocarcinoma of the pancreas. The Phase 1 trial enrolled adults 18 years and older with these advanced solid tumor types. It remains an investigational agent and is not approved for any indication.
CEP-37250/KHK2804 is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva sponsored the Phase 1 study of the compound in advanced solid tumors. The drug is also referenced under the alternate designation KHK2804.
CEP-37250/KHK2804 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed. The study was a controlled, non-randomized, open-label trial that enrolled 71 participants with advanced solid tumors. The compound has not been approved by the FDA.
CEP-37250/KHK2804 has been evaluated in one clinical trial, NCT01447732, titled Phase 1 Study of CEP-37250/KHK2804 in Subjects With Advanced Solid Tumors. That trial is completed and enrolled 71 participants aged 18 years and older, including both sexes, with advanced solid tumors.
Yes, CEP-37250/KHK2804 and KHK2804 refer to the same investigational compound. The dual name reflects the drug's development history, and both designations appear in the clinical trial record for the Phase 1 study in advanced solid tumors. Teva Pharmaceutical Industries Limited is the developer associated with the asset.