Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06964009 | DT2216 + Paclitaxel in Platinum-Resistant Ovarian Cancer | PHASE1 | RECRUITING | 30 | — | — | Sep 22, 2025 | Dec 30, 2027 | Apr 21, 2026 | 3 | United States |
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...