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

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ClinicalTrials.gov Identifier: NCT04983407
Recruitment Status : Recruiting
First Posted : July 30, 2021
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Aravive, Inc.

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
Pancreatic Adenocarcinoma Drug: AVB-S6-500 Drug: Nab paclitaxel Drug: Gemcitabine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 28, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine Drug: AVB-S6-500
AVB-S6-500 is experimental drug

Drug: Nab paclitaxel
Nab paclitaxel is active comparator
Other Name: Abraxane

Drug: Gemcitabine
Gemcitabine is active comparator

Experimental: Phase 2: AVB-S6-500+ nab-paclitaxel and gemcitabine Drug: AVB-S6-500
AVB-S6-500 is experimental drug

Drug: Nab paclitaxel
Nab paclitaxel is active comparator
Other Name: 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 Name: Abraxane

Drug: Gemcitabine
Gemcitabine is active comparator




Primary Outcome Measures :
  1. Incidence of adverse events (AEs) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 months ]
    Area under the AVB-S6-500 concentration-time curve.

  2. Pharmacokinetics: Cmax [ Time Frame: 30 months ]
    Maximum observed AVB-S6-500 concentration.

  3. Pharmacokinetics: Tmax [ Time Frame: 30 months ]
    Time of maximum observed AVB-S6-500 concentration.

  4. Pharmacokinetics: t1/2 [ Time Frame: 30 months ]
    Apparent terminal half-life of AVB-S6-500.

  5. Pharmacodynamic marker assessment [ Time Frame: 30 months ]
    Change from the baseline in GAS6 serum levels.

  6. Anti-drug antibody (ADA) titers [ Time Frame: 30 months ]
    Change from baseline in ADA titer.

  7. Disease control rate [ Time Frame: 30 months ]
    Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

  8. Duration of response (DOR) [ Time Frame: 30 months ]
    Measured from the date of partial or complete response to therapy until the cancer progresses.

  9. Overall survival [ Time Frame: 60 months ]
    Time following the treatment until death.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04983407


Contacts
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Contact: Aravive Clinical Trials 936-355-1910 clinicaltrials@aravive.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Aravive, Inc.
Investigators
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Study Director: Amy Franke Aravive, Inc.
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Responsible Party: Aravive, Inc.
ClinicalTrials.gov Identifier: NCT04983407    
Other Study ID Numbers: AVB500-PC-005
First Posted: July 30, 2021    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gemcitabine
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs