Clinical trial NCT04983407: 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
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: locally advanced
recurrent
metastatic
pancreatic
exocrine
pancreas
adenocarcinoma
Lead sponsor: Aravive, Inc.
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Incidence of adverse events (AEs)
timeFrame: 12 months
measure: Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study
timeFrame: 12 months
measure: Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study
timeFrame: 30 months
Secondary outcomes:
measure: Pharmacokinetics: AUC
timeFrame: 30 months
measure: Pharmacokinetics: Cmax
timeFrame: 30 months
measure: Pharmacokinetics: Tmax
timeFrame: 30 months
measure: Pharmacokinetics: t1/2
timeFrame: 30 months
measure: Pharmacodynamic marker assessment
timeFrame: 30 months
measure: Anti-drug antibody (ADA) titers
timeFrame: 30 months
measure: Disease control rate
timeFrame: 30 months
measure: Duration of response (DOR)
timeFrame: 30 months
measure: Overall survival
timeFrame: 60 months
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: UCLA Health
state: California
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital / Lynn Cancer Institute
state: Florida
city: Tampa
country: United States
facility: Moffit Cancer Center
state: Florida
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
city: Buffalo
country: United States
facility: Roswell Park Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Perlmutter Cancer Center at NYU Langone Health
state: New York
city: Durham
country: United States
facility: Duke University Medical Center (DUMC)
state: North Carolina
city: Canton
country: United States
facility: Gabrail Cancer Center Research
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University / Sidney Kimmel Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN Allegheny General Hospital
state: Pennsylvania
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Milwaukee
country: United States
facility: Froedtert and the Medical College of Wisconsin
state: Wisconsin
Study officials:
References: