Pancreatic Adenocarcinoma
Conditions
Keywords
locally advanced, recurrent, metastatic, pancreatic, exocrine, pancreas, adenocarcinoma
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.
Interventions
DRUGbatiraxcept
Batiraxcept is experimental drug
DRUGNab paclitaxel
Nab paclitaxel is active comparator
DRUGGemcitabine
Gemcitabine is active comparator
Sponsors
Aravive, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics: t1/2 | 30 months | Apparent terminal half-life of batiraxcept. |
| Pharmacodynamic marker assessment | 30 months | Change from the baseline in GAS6 serum levels. |
| Anti-drug antibody (ADA) titers | 30 months | Change from baseline in ADA titer. |
| Pharmacokinetics: AUC | 30 months | Area under the batiraxcept concentration-time curve. |
| Duration of response (DOR) | 30 months | Measured from the date of partial or complete response to therapy until the cancer progresses. |
| Overall survival | 60 months | Time following the treatment until death. |
| Disease control rate | 30 months | Proportion of subjects who have a complete or partial response to therapy or maintain stable disease. |
| Pharmacokinetics: Cmax | 30 months | Maximum observed batiraxcept concentration. |
| Pharmacokinetics: Tmax | 30 months | Time of maximum observed batiraxcept concentration. |
Countries
United States
Outcome results
None listed