Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced Pancreatic Adenocarcinoma
- Conditions
- Pancreatic Adenocarcinoma
- Interventions
- Registration Number
- NCT04983407
- Lead Sponsor
- Aravive, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 34
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine Nab paclitaxel - Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine Nab paclitaxel Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine batiraxcept Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine Phase 2: nab-paclitaxel and gemcitabine alone Nab paclitaxel - Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine Gemcitabine Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine batiraxcept - Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine Gemcitabine - Phase 2: nab-paclitaxel and gemcitabine alone Gemcitabine -
- Primary Outcome Measures
Name Time Method Anti-tumor activity of batiraxcept 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.
Incidence of adverse events (AEs) 12 months 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 2 portion of the study 30 months 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
Name Time Method Pharmacokinetics: AUC 30 months Area under the batiraxcept concentration-time curve.
Pharmacokinetics: t1/2 30 months Apparent terminal half-life of batiraxcept.
Disease control rate 30 months Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Overall survival 60 months Time following the treatment until death.
Pharmacokinetics: Cmax 30 months Maximum observed batiraxcept concentration.
Duration of response (DOR) 30 months Measured from the date of partial or complete response to therapy until the cancer progresses.
Pharmacokinetics: Tmax 30 months Time of maximum observed batiraxcept concentration.
Anti-drug antibody (ADA) titers 30 months Change from baseline in ADA titer.
Pharmacodynamic marker assessment 30 months Change from the baseline in GAS6 serum levels.
Trial Locations
- Locations (17)
UCLA Health
🇺🇸Santa Monica, California, United States
Fox Chase Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Boca Raton Regional Hospital / Lynn Cancer Institute
🇺🇸Boca Raton, Florida, United States
Roswell Park Comprehensive Cancer Center
🇺🇸Buffalo, New York, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Perlmutter Cancer Center at NYU Langone Health
🇺🇸New York, New York, United States
Gabrail Cancer Center Research
🇺🇸Canton, Ohio, United States
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
AHN Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Thomas Jefferson University / Sidney Kimmel Cancer Center
🇺🇸Philadelphia, Pennsylvania, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Moffit Cancer Center
🇺🇸Tampa, Florida, United States
Michigan Medicine - University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Duke University Medical Center (DUMC)
🇺🇸Durham, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
Froedtert and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States