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

Primary Purpose

Pancreatic Adenocarcinoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
batiraxcept
Nab paclitaxel
Gemcitabine
Sponsored by
Aravive, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Adenocarcinoma focused on measuring locally advanced, recurrent, metastatic, pancreatic, exocrine, pancreas, adenocarcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA HealthRecruiting
  • Boca Raton Regional Hospital / Lynn Cancer InstituteRecruiting
  • Moffit Cancer Center
  • University of Massachusetts Memorial Medical Center
  • Michigan Medicine - University of MichiganRecruiting
  • Roswell Park Comprehensive Cancer CenterRecruiting
  • Perlmutter Cancer Center at NYU Langone HealthRecruiting
  • Duke University Medical Center (DUMC)Recruiting
  • Gabrail Cancer Center ResearchRecruiting
  • Cleveland Clinic FoundationRecruiting
  • Oregon Health and Science UniversityRecruiting
  • Abramson Cancer Center of the University of Pennsylvania
  • Thomas Jefferson University / Sidney Kimmel Cancer Center
  • Fox Chase Cancer Center
  • AHN Allegheny General Hospital
  • Virginia Cancer SpecialistsRecruiting
  • Froedtert and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine

Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine

Phase 2: nab-paclitaxel and gemcitabine alone

Arm Description

Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine

Outcomes

Primary Outcome Measures

Incidence of adverse events (AEs)
Measured by the number of patients with AEs in Phase 1b portion of the study.
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
July 8, 2021
Last Updated
February 8, 2023
Sponsor
Aravive, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04983407
Brief Title
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aravive, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Adenocarcinoma
Keywords
locally advanced, recurrent, metastatic, pancreatic, exocrine, pancreas, adenocarcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine
Arm Type
Experimental
Arm Description
Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
Arm Title
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine
Arm Type
Experimental
Arm Title
Phase 2: nab-paclitaxel and gemcitabine alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
batiraxcept
Other Intervention Name(s)
AVB-S6-500
Intervention Description
Batiraxcept is experimental drug
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Other Intervention Name(s)
Abraxane
Intervention Description
Nab paclitaxel is active comparator
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine is active comparator
Primary Outcome Measure Information:
Title
Incidence of adverse events (AEs)
Description
Measured by the number of patients with AEs in Phase 1b portion of the study.
Time Frame
12 months
Title
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study
Description
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.
Time Frame
12 months
Title
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study
Description
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.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics: AUC
Description
Area under the batiraxcept concentration-time curve.
Time Frame
30 months
Title
Pharmacokinetics: Cmax
Description
Maximum observed batiraxcept concentration.
Time Frame
30 months
Title
Pharmacokinetics: Tmax
Description
Time of maximum observed batiraxcept concentration.
Time Frame
30 months
Title
Pharmacokinetics: t1/2
Description
Apparent terminal half-life of batiraxcept.
Time Frame
30 months
Title
Pharmacodynamic marker assessment
Description
Change from the baseline in GAS6 serum levels.
Time Frame
30 months
Title
Anti-drug antibody (ADA) titers
Description
Change from baseline in ADA titer.
Time Frame
30 months
Title
Disease control rate
Description
Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Time Frame
30 months
Title
Duration of response (DOR)
Description
Measured from the date of partial or complete response to therapy until the cancer progresses.
Time Frame
30 months
Title
Overall survival
Description
Time following the treatment until death.
Time Frame
60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aravive Clinical Trials
Phone
936-355-1910
Email
clinicaltrials@aravive.com
Facility Information:
Facility Name
UCLA Health
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Yonemoto
Phone
310-633-8400
Email
Lyonemoto@mednet.ucla.edu
Facility Name
Boca Raton Regional Hospital / Lynn Cancer Institute
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvie Godbout, RN
Phone
561-955-4539
Email
sgodbout@baptisthealth.net
Facility Name
Moffit Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Ponto
Phone
813-745-7658
Facility Name
University of Massachusetts Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
U-Mass Cancer Research Office
Phone
508-856-3216
Email
cancer.research@umassmed.edu
Facility Name
Michigan Medicine - University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cancer AnswerLine
Phone
800-865-1125
Facility Name
Roswell Park Comprehensive Cancer Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roswell Park Clinical Trials Information Line
Phone
800-767-9355
Email
askroswell@roswellpark.org
Facility Name
Perlmutter Cancer Center at NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pamela Baga
Phone
212-731-6221
Email
Pamela.Baga@nyulangone.org
Facility Name
Duke University Medical Center (DUMC)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelsey Conner
Phone
919-668-1861
Email
kelsey.conner@duke.edu
Facility Name
Gabrail Cancer Center Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Smith, RN
Phone
330-417-8231
Email
csmith@gabrailcancercenter.com
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tiffany Schaafsma, RN
Phone
216-445-1510
Email
AAFT@ccf.org
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Knight Clinical Trials Information Line
Phone
503-494-1080
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Hoffer
Phone
215-349-8913
Email
khoffer@pennmedicine.upenn.edu
Facility Name
Thomas Jefferson University / Sidney Kimmel Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office
Phone
215-955-1661
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Efrat Dotan, MD
Phone
888-369-2427
Facility Name
AHN Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
(412) 330-6151
Email
clinicaltrials@ahn.org
Facility Name
Virginia Cancer Specialists
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carrie Friedman
Phone
703-636-1473
Email
vcsclinicaltrials@usoncology.com
Facility Name
Froedtert and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MCW Cancer Center Clinical Trials Office
Phone
414-805-8900
Email
cccto@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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