drugset / Trial / NCT04983407
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
RandomizedSingle-groupOpen-labelTreatment
Summary
This is a Phase 1b/2 study of batiraxcept (AVB-S6-500) designed to evaluate the safety and efficacy of batiraxcept in combination with nab-paclitaxel and gemcitabine in subjects with locally advanced, recurrent, or metastatic pancreatic adenocarcinoma as first line therapy. The phase 1b portion of the study is open label and patients will receive batiraxcept, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of batiraxcept, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.
Timeline
- Start
- 2021-07-28
- Primary completion
- 2023-08-14
- Completion
- 2023-08-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Batiraxcept | Protein / enzyme biologic | — | — |
| Background | Gemcitabine | Small molecule | — | — |
| Background | Paclitaxel | Small molecule | — | — |