Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DMOT4039A · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| DMOT4039A Q3W: Dose Escalation | EXPERIMENTAL | Participants in different cohorts will receive DMOT4039A at various escalating dose levels, starting with 0.2 milligrams per kilogram (mg/kg), as intravenous infusion every 3 weeks (Q3W) to determine the maximum tolerated dose (MTD) of DMOT4039A for until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (up to approximately 2.5 years). |
| DMOT4039A Q3W: Dose Expansion | EXPERIMENTAL | Participants will receive DMOT4039A at recommended phase 2 dose (RP2D) for Q3W dosing schedule as intravenous infusion Q3W until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (up to approximately 2.5 years). |
| DMOT4039A Q1W: Dose Escalation | EXPERIMENTAL | Participants in different cohorts will receive DMOT4039A at various escalating dose levels, starting with a dose 33% of MTD for Q3W dosing schedule, as intravenous infusion every week (Q1W) to determine the MTD of DMOT4039A for until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (up to approximately 2.5 years). |
| DMOT4039A Q1W: Dose Expansion | EXPERIMENTAL | Participants will receive DMOT4039A at RP2D for Q1W dosing schedule as intravenous infusion Q1W until disease progression, loss of clinical benefit or unacceptable toxicity, whichever occurred first (up to approximately 2.5 years). |
| Name | Type | Description |
|---|---|---|
| DMOT4039A | DRUG | DMOT4093A will be administered by intravenous infusion on either a Q3W or a Q1W dosing schedule, in 21-day cycles. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Histologically documented, incurable, locally advanced or metastatic disease for which no standard therapy exists, consisting of one of the following: Unresectable pancreatic ductal adenocarcinoma or platinu...
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DMOT4039A is an investigational small molecule being studied for the treatment of ovarian cancer. It is currently in Phase 1 clinical development, with a completed trial that evaluated the drug in participants with unresectable pancreatic or platinum-resistant ovarian cancer.
DMOT4039A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational oncology drug for ovarian cancer.
DMOT4039A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 trial has been completed, and the drug remains under clinical investigation for ovarian cancer.
DMOT4039A has one completed clinical trial, NCT01469793, titled "A Study of DMOT4039A in Participants With Unresectable Pancreatic or Platinum-Resistant Ovarian Cancer." This Phase 1 study enrolled 71 participants and was conducted in the United States and Netherlands.
DMOT4039A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for ovarian cancer. The completed trial, NCT01469793, was a controlled study, but the drug has not received regulatory approval.