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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: batiraxcept; Drug: Nab paclitaxel; Drug: Gemcitabine

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • UCLA Health
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Boca Raton Regional Hospital / Lynn Cancer Institute
    • Tampa, Florida, United States, 33612
      • Moffit Cancer Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts Memorial Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • Michigan Medicine - University of Michigan
  • New York
    • Buffalo, New York, United States, 14263
      • Roswell Park Comprehensive Cancer Center
    • New York, New York, United States, 10016
      • Perlmutter Cancer Center at NYU Langone Health
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center (DUMC)
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center Research
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Abramson Cancer Center of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University / Sidney Kimmel Cancer Center
    • Pittsburgh, Pennsylvania, United States, 15212
      • AHN Allegheny General Hospital
  • Virginia
    • Fairfax, Virginia, United States, 22031
      • Virginia Cancer Specialists
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert and The Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years or older
• Histologically or cytologically confirmed pancreatic adenocarcinoma. Must have locally advanced, recurrent, or metastatic disease ineligible for curative intent treatment(s) and eligible for first line systemic treatment.
• Must have radiologic imaging with a computed tomography (CT) scan or magnetic resonance imaging (MRI) within 22 days of study entry
• Must have at least one measurable lesion according to RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Adequate gastrointestinal (GI), bone marrow, liver and kidney function
• Life expectancy minimum of > 12 weeks
• Adequate recovery from surgery to Grade 1 or baseline with at least 28 days from time of major surgery

Exclusion Criteria:

• Received last dose of chemotherapy (neoadjuvant or adjuvant), surgery, or radiation treatment with curative intent within 6 months prior to study entry
• Islet-cell neoplasms
• Prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix, breast or melanoma
• Symptomatic uncontrolled central nervous system (CNS) metastasis or brain metastases unless adequately treated and controlled
• Evidence of clinically significant third spacing (e.g. pleural effusion, ascites, anasarca, etc.) within 28 days prior to study entry
• Serious active infection requiring IV antibiotics and/or hospitalization at study entry
• Active human immune deficiency (HIV) syndrome, hepatitis B, hepatitis C, or other active viral illness

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine	Drug: batiraxcept; Batiraxcept is experimental drug; Other Names: AVB-S6-500; Drug: Nab paclitaxel; Nab paclitaxel is active comparator; Other Names: Abraxane; Drug: Gemcitabine; Gemcitabine is active comparator
Active Comparator: Phase 2: nab-paclitaxel and gemcitabine alone	Drug: Nab paclitaxel; Nab paclitaxel is active comparator; Other Names: Abraxane; Drug: Gemcitabine; Gemcitabine is active comparator
Experimental: Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine; Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine	Drug: batiraxcept; Batiraxcept is experimental drug; Other Names: AVB-S6-500; Drug: Nab paclitaxel; Nab paclitaxel is active comparator; Other Names: Abraxane; Drug: Gemcitabine; Gemcitabine is active comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events (AEs)	Measured by the number of patients with AEs in Phase 1b portion of the study.	12 months
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study	Measured by Objective Response Rate (ORR): Proportion of subjects who have a partial or complete response to therapy relative to baseline in Phase 1b portion of the study.	12 months
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study	Measured by progression free survival (PFS) in patients receiving batiraxcept, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2.	30 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacodynamic marker assessment	Change from the baseline in GAS6 serum levels.	30 months
Anti-drug antibody (ADA) titers	Change from baseline in ADA titer.	30 months
Disease control rate	Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.	30 months
Duration of response (DOR)	Measured from the date of partial or complete response to therapy until the cancer progresses.	30 months
Overall survival	Time following the treatment until death.	60 months
Pharmacokinetics: AUC	Area under the batiraxcept concentration-time curve.	30 months
Pharmacokinetics: Cmax	Maximum observed batiraxcept concentration.	30 months
Pharmacokinetics: Tmax	Time of maximum observed batiraxcept concentration.	30 months
Pharmacokinetics: t1/2	Apparent terminal half-life of batiraxcept.	30 months

Collaborators and Investigators

• Sponsor: Aravive, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): August 14, 2023
• Study Completion (Actual): August 14, 2023

Study Registration Dates

• First Submitted: July 8, 2021
• First Submitted That Met QC Criteria: July 20, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: pancreas; metastatic; adenocarcinoma; pancreatic; recurrent; locally advanced; exocrine
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel; Gemcitabine
• Other Study ID Numbers: AVB500-PC-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No