Approval Probability
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Adjusted LOA
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DMUC4064A · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Dose-escalation Cohort | EXPERIMENTAL | DMUC4064A will be administered to participants at a starting dose of 1.0 milligram per kilogram (mg/kg) by IV infusion q3w and would be monitored for DLTs for 21 days after first infusion of Cycle 1 (cycle length=21 days). |
| Platinum-resistant Ovarian Cancer Dose-expansion Cohort | EXPERIMENTAL | Platinum-resistant Ovarian Cancer participants will be administered with the identified RP2D during the Dose-escalation of DMUC4064A q3w IV for up to until disease progression or death, whichever occurs first. |
| Unresectable Pancreatic Cancer Dose-expansion Cohort | EXPERIMENTAL | Unresectable pancreatic cancer participants will be administered with the identified RP2D during the dose-escalation of DMUC4064A q3w IV for up to until disease progression or death, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| DMUC4064A | DRUG | Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days). |
Inclusion Criteria: * Life expectancy of at least 12 weeks * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Measurable disease is defined as at least one bi-dimensionally measurable non-lymph node lesion greater than or equal to (\>/=) 1 centimeter (cm) on long access diam...
DMUC4064A is an investigational small molecule being studied for the treatment of pancreatic neoplasms, specifically unresectable pancreatic cancer. It was evaluated in a Phase 1 clinical trial that also included participants with platinum-resistant ovarian cancer. The drug is still in clinical development and has not been approved by regulatory authorities.
DMUC4064A is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical research to evaluate the safety and pharmacokinetics of this investigational oncology drug.
DMUC4064A is in Phase 1 clinical development. A Phase 1 trial has been completed, which focused on evaluating the safety and pharmacokinetics of the drug in participants with platinum-resistant ovarian cancer or unresectable pancreatic cancer. The drug remains investigational and is not yet approved for any use.
DMUC4064A has been studied in one completed clinical trial registered as NCT02146313. This Phase 1 study evaluated the safety and pharmacokinetics of the drug in 35 participants with platinum-resistant ovarian cancer or unresectable pancreatic cancer. The trial was conducted in the United States and enrolled adults aged 18 years and older.
DMUC4064A is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial, but it has not received regulatory approval for any indication. The drug is still in clinical development, and further studies would be needed to establish its safety and efficacy before any approval could be considered.