drugset / Trial / NCT04983407

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma

NCT04983407

Phase 1/2 Terminated 34 enrolled Aravive, Inc.
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

EvaluationDrugModalityDoseRoute
Subject Batiraxcept Protein / enzyme biologic
Background Gemcitabine Small molecule
Background Paclitaxel Small molecule