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

Sponsor
Aravive, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04983407
Collaborator
(none)
80
Enrollment
17
Locations
3
Arms
32.1
Anticipated Duration (Months)
4.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of AVB-S6-500 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 AVB-S6-500, nab-paclitaxel, and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of AVB-S6-500, nab-paclitaxel, and gemcitabine versus nab-paclitaxel and gemcitabine as first line therapy.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1b/2 Randomized Study of AVB-S6-500 Plus Nab-paclitaxel and Gemcitabine in Patients With Locally Advanced or Metastatic Pancreatic Adenocarcinoma
Actual Study Start Date :
Jul 28, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Phase 1b: 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
    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

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of adverse events (AEs) [12 months]

      Measured by the number of patients with AEs in Phase 1b portion of the study.

    2. Anti-tumor activity of AVB-S6-500 in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study [12 months]

      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.

    3. Anti-tumor activity of AVB-S6-500 in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study [30 months]

      Measured by progression free survival (PFS) in patients receiving AVB-S6-500, nab-paclitaxel, and gemcitabine versus patients receiving nab-paclitaxel, and gemcitabine alone in Phase 2.

    Secondary Outcome Measures

    1. Pharmacokinetics: AUC [30 months]

      Area under the AVB-S6-500 concentration-time curve.

    2. Pharmacokinetics: Cmax [30 months]

      Maximum observed AVB-S6-500 concentration.

    3. Pharmacokinetics: Tmax [30 months]

      Time of maximum observed AVB-S6-500 concentration.

    4. Pharmacokinetics: t1/2 [30 months]

      Apparent terminal half-life of AVB-S6-500.

    5. Pharmacodynamic marker assessment [30 months]

      Change from the baseline in GAS6 serum levels.

    6. Anti-drug antibody (ADA) titers [30 months]

      Change from baseline in ADA titer.

    7. Disease control rate [30 months]

      Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

    8. Duration of response (DOR) [30 months]

      Measured from the date of partial or complete response to therapy until the cancer progresses.

    9. Overall survival [60 months]

      Time following the treatment until death.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 or breast

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UCLA Health Santa Monica California United States 90404
    2 Boca Raton Regional Hospital / Lynn Cancer Institute Boca Raton Florida United States 33486
    3 Moffit Cancer Center Tampa Florida United States 33612
    4 University of Massachusetts Memorial Medical Center Worcester Massachusetts United States 01655
    5 Michigan Medicine - University of Michigan Ann Arbor Michigan United States 48108
    6 Roswell Park Comprehensive Cancer Center Buffalo New York United States 14263
    7 Perlmutter Cancer Center at NYU Langone Health New York New York United States 10016
    8 Duke University Medical Center (DUMC) Durham North Carolina United States 27710
    9 Gabrail Cancer Center Research Canton Ohio United States 44718
    10 Cleveland Clinic Foundation Cleveland Ohio United States 44195
    11 Oregon Health and Science University Portland Oregon United States 97239
    12 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
    13 Thomas Jefferson University / Sidney Kimmel Cancer Center Philadelphia Pennsylvania United States 19107
    14 Fox Chase Cancer Center Philadelphia Pennsylvania United States 19111
    15 AHN Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    16 Virginia Cancer Specialists Fairfax Virginia United States 22031
    17 Froedtert and the Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Aravive, Inc.

    Investigators

    • Study Director: Amy Franke, Aravive, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aravive, Inc.
    ClinicalTrials.gov Identifier:
    NCT04983407
    Other Study ID Numbers:
    • AVB500-PC-005
    First Posted:
    Jul 30, 2021
    Last Update Posted:
    Feb 22, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Aravive, Inc.
    locally advanced
    recurrent
    metastatic
    pancreatic
    exocrine
    pancreas
    adenocarcinoma
    Additional relevant MeSH terms:
    Adenocarcinoma
    Gemcitabine
    Paclitaxel

    Study Results

    No Results Posted as of Feb 22, 2022