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Pancreatic AdenocarcinomaPhase 1/2NCT04983407

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

A Phase 1/2 study testing batiraxcept, Nab paclitaxel and Gemcitabine in people with Pancreatic Adenocarcinoma, run by Aravive, Inc. at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Adenocarcinoma
What is being tested?
batiraxcept, Nab paclitaxel and Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
17 sitesUnited States
Study dates
28 Jul 2021to 14 Aug 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • Michigan Medicine - University of Michigan

    Ann Arbor, Michigan, 48108

  • Boca Raton Regional Hospital / Lynn Cancer Institute

    Boca Raton, Florida, 33486

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • Gabrail Cancer Center Research

    Canton, Ohio, 44718

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Duke University Medical Center (DUMC)

    Durham, North Carolina, 27710

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Perlmutter Cancer Center at NYU Langone Health

    New York, New York, 10016

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University / Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • UCLA Health

    Santa Monica, California, 90404

  • Moffit Cancer Center

    Tampa, Florida, 33612

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

About this study

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

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.

Being tested
batiraxcept, Nab paclitaxel, Gemcitabine
Keywords
locally advanced, recurrent, metastatic, pancreatic, exocrine, pancreas, adenocarcinoma
Medical subject headings
Recurrence, Neoplasm Metastasis, Adenocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • batiraxceptDrug

    Also called AVB-S6-500

    Batiraxcept is experimental drug

  • Nab paclitaxelDrug

    Also called Abraxane

    Nab paclitaxel is active comparator

  • GemcitabineDrug

    Gemcitabine is active comparator

Study groups in NCT04983407
Study groupRoleWhat they receive
Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabineExperimentalUp to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
Receives: Drug: batiraxcept; Drug: Nab paclitaxel; Drug: Gemcitabine
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabineExperimentalNot described
Receives: Drug: batiraxcept; Drug: Nab paclitaxel; Drug: Gemcitabine
Phase 2: nab-paclitaxel and gemcitabine aloneActive comparatorNot described
Receives: Drug: Nab paclitaxel; Drug: Gemcitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events (AEs)

    Measured by the number of patients with AEs in Phase 1b portion of the study.

    Measured: 12 months

  2. Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study

    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.

    Measured: 12 months

  3. Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study

    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.

    Measured: 30 months

Secondary outcomes (9)

  1. Pharmacokinetics: AUC

    Area under the batiraxcept concentration-time curve.

    Measured: 30 months

  2. Pharmacokinetics: Cmax

    Maximum observed batiraxcept concentration.

    Measured: 30 months

  3. Pharmacokinetics: Tmax

    Time of maximum observed batiraxcept concentration.

    Measured: 30 months

  4. Pharmacokinetics: t1/2

    Apparent terminal half-life of batiraxcept.

    Measured: 30 months

  5. Pharmacodynamic marker assessment

    Change from the baseline in GAS6 serum levels.

    Measured: 30 months

  6. Anti-drug antibody (ADA) titers

    Change from baseline in ADA titer.

    Measured: 30 months

  7. Disease control rate

    Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

    Measured: 30 months

  8. Duration of response (DOR)

    Measured from the date of partial or complete response to therapy until the cancer progresses.

    Measured: 30 months

  9. Overall survival

    Time following the treatment until death.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2021
  2. Study start28 Jul 2021
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Why it stopped: Due to business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04983407
Sponsor's protocol ID
AVB500-PC-005
Status last verified
Oct 2023
First submitted
8 Jul 2021
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing batiraxcept, Nab paclitaxel and Gemcitabine in people with Pancreatic Adenocarcinoma, run by Aravive, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (AEs) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04983407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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