Description:
This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of
AVB-S6-500 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 AVB-S6-500, nab-paclitaxel,
and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to
compare efficacy and tolerability of AVB-S6-500, nab-paclitaxel, and gemcitabine versus
nab-paclitaxel and gemcitabine as first line therapy.
Title
- Brief Title: Safety and Efficacy Study of AVB-S6-500 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
Clinical Trial IDs
- ORG STUDY ID:
AVB500-PC-005
- NCT ID:
NCT04983407
Conditions
- Pancreatic Adenocarcinoma
Interventions
Drug | Synonyms | Arms |
---|
AVB-S6-500 | | Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine |
Nab paclitaxel | Abraxane | Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine |
Gemcitabine | | Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine |
Purpose
This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of
AVB-S6-500 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 AVB-S6-500, nab-paclitaxel,
and gemcitabine. The Phase 2 portion of the study is randomized, 2-arm, open-label study to
compare efficacy and tolerability of AVB-S6-500, nab-paclitaxel, and gemcitabine versus
nab-paclitaxel and gemcitabine as first line therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine | Experimental | | - AVB-S6-500
- Nab paclitaxel
- Gemcitabine
|
Phase 2: AVB-S6-500+ nab-paclitaxel and gemcitabine | Experimental | | - AVB-S6-500
- Nab paclitaxel
- Gemcitabine
|
Phase 2: nab-paclitaxel and gemcitabine alone | Active Comparator | | - Nab paclitaxel
- Gemcitabine
|
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 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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Incidence of adverse events (AEs) |
Time Frame: | 12 months |
Safety Issue: | |
Description: | Measured by the number of patients with AEs in Phase 1b portion of the study. |
Secondary Outcome Measures
Measure: | Pharmacokinetics: AUC |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Area under the AVB-S6-500 concentration-time curve. |
Measure: | Pharmacokinetics: Cmax |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Maximum observed AVB-S6-500 concentration. |
Measure: | Pharmacokinetics: Tmax |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Time of maximum observed AVB-S6-500 concentration. |
Measure: | Pharmacokinetics: t1/2 |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Apparent terminal half-life of AVB-S6-500. |
Measure: | Pharmacodynamic marker assessment |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Change from the baseline in GAS6 serum levels. |
Measure: | Anti-drug antibody (ADA) titers |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Change from baseline in ADA titer. |
Measure: | Disease control rate |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Proportion of subjects who have a complete or partial response to therapy or maintain stable disease. |
Measure: | Duration of response (DOR) |
Time Frame: | 30 months |
Safety Issue: | |
Description: | Measured from the date of partial or complete response to therapy until the cancer progresses. |
Measure: | Overall survival |
Time Frame: | 60 months |
Safety Issue: | |
Description: | Time following the treatment until death. |
Details
Phase: | Phase 1/Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Aravive, Inc. |
Trial Keywords
- locally advanced
- recurrent
- metastatic
- pancreatic
- exocrine
- pancreas
- adenocarcinoma
Last Updated
August 5, 2021