NCT04983407

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

A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Aravive, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	batiraxcept	Batiraxcept is experimental drug
DRUG	Nab paclitaxel	Nab paclitaxel is active comparator
DRUG	Gemcitabine	Gemcitabine is active comparator

Timeline

• Start date: 2021-07-28
• Primary completion: 2023-08-14
• Completion: 2023-08-14
• First posted: 2021-07-30
• Last updated: 2023-10-30

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study