Clinical Trials /

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

NCT04983407

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.

Related Conditions:
  • Pancreatic Adenocarcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
AVB-S6-500Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine
Nab paclitaxelAbraxanePhase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabine
GemcitabinePhase 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

NameTypeDescriptionInterventions
Phase 1b: AVB-S6-500+ nab-paclitaxel and gemcitabineExperimental
  • AVB-S6-500
  • Nab paclitaxel
  • Gemcitabine
Phase 2: AVB-S6-500+ nab-paclitaxel and gemcitabineExperimental
  • AVB-S6-500
  • Nab paclitaxel
  • Gemcitabine
Phase 2: nab-paclitaxel and gemcitabine aloneActive 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