Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
NCT ID: NCT04983407
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
34 participants
INTERVENTIONAL
2021-07-28
2023-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine
Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
batiraxcept
Batiraxcept is experimental drug
Nab paclitaxel
Nab paclitaxel is active comparator
Gemcitabine
Gemcitabine is active comparator
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine
batiraxcept
Batiraxcept is experimental drug
Nab paclitaxel
Nab paclitaxel is active comparator
Gemcitabine
Gemcitabine is active comparator
Phase 2: nab-paclitaxel and gemcitabine alone
Nab paclitaxel
Nab paclitaxel is active comparator
Gemcitabine
Gemcitabine is active comparator
Interventions
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batiraxcept
Batiraxcept is experimental drug
Nab paclitaxel
Nab paclitaxel is active comparator
Gemcitabine
Gemcitabine is active comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Aravive, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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AVB500-PC-005
Identifier Type: -
Identifier Source: org_study_id
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