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

Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04983407
• Other study ID #: AVB500-PC-005
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: July 28, 2021
• Est. completion date: August 14, 2023

Study information

• Verified date: October 2023
• Source: Aravive, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenocarcinoma
• Pancreatic Adenocarcinoma

Intervention

Drug:
• batiraxcept
Batiraxcept is experimental drug
• Nab paclitaxel
Nab paclitaxel is active comparator
• Gemcitabine
Gemcitabine is active comparator

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Aravive, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	Measured by the number of patients with AEs in Phase 1b portion of the study.	12 months
Primary	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.	12 months
Primary	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.	30 months
Secondary	Pharmacokinetics: AUC	Area under the batiraxcept concentration-time curve.	30 months
Secondary	Pharmacokinetics: Cmax	Maximum observed batiraxcept concentration.	30 months
Secondary	Pharmacokinetics: Tmax	Time of maximum observed batiraxcept concentration.	30 months
Secondary	Pharmacokinetics: t1/2	Apparent terminal half-life of batiraxcept.	30 months
Secondary	Pharmacodynamic marker assessment	Change from the baseline in GAS6 serum levels.	30 months
Secondary	Anti-drug antibody (ADA) titers	Change from baseline in ADA titer.	30 months
Secondary	Disease control rate	Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.	30 months
Secondary	Duration of response (DOR)	Measured from the date of partial or complete response to therapy until the cancer progresses.	30 months
Secondary	Overall survival	Time following the treatment until death.	60 months