Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DT2216 · 1 trial · 4 indications
The DT2216 MTD in combination with paclitaxel is determined by the number of participants who experience dose-limiting toxicity (DLT) during cycle 1 and up to start of cycle 2. Dose (de-)escalation rules and the related selection of the MTD are based on the Bayesian Optimal Interval Design (BOIN).
A DLT is defined as including grade 3 or higher non-hematologic toxicity with some exclusions and specific hematologic toxicities, both not clearly due to the underlying disease or extraneous causes, along with any death, treatment delays\>14 days and inability to receive at least 75% of assigned doses of each agent.
| Arm | Type | Description |
|---|---|---|
| DT2216 + Paclitaxel | EXPERIMENTAL | Dose de-escalation and escalation for the DT2216 and Pacllitaxel combination will be guided using a Bayesian Optimal Interval (BOIN) design. Enrolled participants will complete: * Baseline visit * Imaging every 2 cycles * ECG Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycle 2. * Research blood sample Days 1, 2, 4, 8, 15, 16, 18 and 22 of Cycle 1 and Day 1 of every cycle. * Cycle 1 (28 day cycles): * Days 1, 4, 8, 11, 15, 18, 22, and 25: Predetermined dose of DT2216 1x daily * Days 1, 8, 15: Predetermined dose of Paclitaxel 1x daily * Cycle 2 through end of treatment (28 day cycles): * Days 1, 4, 8, 11, 15, 18, 22, 25: Predetermined dose of DT2216 1x daily * Days 1, 8, 15: Predetermined dose of Paclitaxel 1x daily * End of treatment visit with imaging * 30 day follow up visit |
| Name | Type | Description |
|---|---|---|
| DT2216 | DRUG | A proteolysis-targeting chimera (PROTAC) degrader, single-use vial, via intravenous (into the vein) infusion. |
| Paclitaxel | DRUG | An antimicrotubule agent, multi-dose vial, via intravenous (into the vein) infusion per institutional standard. |
Inclusion Criteria: * Participants must have histologically confirmed relapsed or refractory ovarian cancer (including epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma). * Participants must have measurable disease, defined as at least one lesion that can be accur...
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DT2216 is an investigational small molecule being studied for the treatment of ovarian cancer, specifically recurrent platinum-resistant ovarian carcinoma. It is currently in Phase 1 clinical development and is being evaluated in combination with paclitaxel in patients with this condition.
DT2216 is a small molecule being developed for oncology. Its specific molecular target has not been disclosed in available clinical trial information. The drug is being studied in combination with paclitaxel for the treatment of platinum-resistant ovarian cancer.
DT2216 is being developed by United Therapeutics Corporation, a publicly traded company listed on NASDAQ under the ticker symbol UTHR. The company is conducting a Phase 1 clinical trial of DT2216 in patients with recurrent platinum-resistant ovarian cancer.
DT2216 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients with recurrent platinum-resistant ovarian cancer in the United States.
DT2216 is being evaluated in a single Phase 1 clinical trial with the identifier NCT06964009. This trial is titled 'DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer' and is currently recruiting participants. The study is enrolling female patients aged 18 years and older with recurrent platinum-resistant ovarian carcinoma.
DT2216 is a distinct investigational small molecule being developed by United Therapeutics Corporation. No alternative names for this drug have been reported in the clinical trial information. It is being studied specifically for the treatment of recurrent platinum-resistant ovarian cancer.