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

Stopped early · Phase 1/Phase 2

Conditions studied: Pancreatic Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04983407

Run by

Aravive, Inc.

People needed

34

Starts

2021-07-28

Expected to finish

2023-08-14

Last updated by the study team

2023-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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