drugset / Trial / NCT06266143
A Trial of Y101D in Combination With Gemcitabine and Albumin Paclitaxel in Patients With Advanced Pancreatic Cancer
NaSingle-groupOpen-labelTreatment
Summary
The Phase Ib/II study is an open-label, single-arm, multicenter trial designed to assess the efficacy and safety of Y101D in combination with Gemcitabine and Albumin Paclitaxel as first-line systemic treatment for advanced pancreatic cancer patients. The Phase Ib portion of the study aims to evaluate the safety of escalating doses of Y101D in combination with the standard regimen of Gemcitabine and Albumin Paclitaxel and determine the recommended phase 2 dose (RP2D). The Phase II portion of the study aims to evaluate the effectiveness of this combination treatment in a small population of patients.
Timeline
- Start
- 2023-02-08
- Primary completion
- 2025-01-21
- Completion
- 2025-01-21
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Y101D | Unknown | 20 mg/kg | Intravenous |
| Subject | Y101D | Unknown | 30 mg/kg | Intravenous |
| Background | Gemcitabine | Small molecule | — | Intravenous |
| Background | Nab-paclitaxel | Small molecule | — | Intravenous |