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

NCT04983407 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-10-30

No results posted yet for this study

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

DRUG

batiraxcept

Batiraxcept is experimental drug

DRUG

Nab paclitaxel

Nab paclitaxel is active comparator

DRUG

Gemcitabine

Gemcitabine is active comparator

Sponsors & Collaborators

  • Aravive, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2023-08-14
Completion
2023-08-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04983407 on ClinicalTrials.gov