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Monoclonal Antibodies

batiraxcept for Pancreatic Adenocarcinoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Aravive, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Life expectancy minimum of > 12 weeks
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer drug (AVB-S6-500) to see if it is safe and effective when used with two other drugs (nab-paclitaxel and gemcitabine) to treat pancreatic cancer. The trial has two parts: in the first part, all patients receive AVB-S6-500, nab-paclitaxel, and gemcitabine; in the second part, patients are randomly assigned to receive either AVB-S6-500, nab-paclitaxel, and gemcitabine or nab-paclitaxel and gemcitabine

Eligible Conditions
  • Pancreatic Adenocarcinoma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are expected to live for at least 12 more weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-tumor activity of batiraxcept in combination with nab-paclitaxel and gemcitabine 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
Incidence of adverse events (AEs)
Secondary outcome measures
Anti-drug antibody (ADA) titers
Disease control rate
Duration of response (DOR)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2: batiraxcept+ nab-paclitaxel and gemcitabineExperimental Treatment3 Interventions
Group II: Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabineExperimental Treatment3 Interventions
Up to three dose levels of bactiraxcept plus nab-paclitaxel and gemcitabine
Group III: Phase 2: nab-paclitaxel and gemcitabine aloneActive Control2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nab paclitaxel
2014
Completed Phase 2
~70
Gemcitabine
2017
Completed Phase 3
~2070

Find a Location

Who is running the clinical trial?

Aravive, Inc.Lead Sponsor
8 Previous Clinical Trials
590 Total Patients Enrolled
Amy FrankeStudy DirectorAravive, Inc.
3 Previous Clinical Trials
491 Total Patients Enrolled
Eduardo Pennella, MDStudy DirectorAravive, Inc.
4 Previous Clinical Trials
1,298 Total Patients Enrolled

Media Library

AVB-S6-500 (Batiraxcept) (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04983407 — Phase 1 & 2
Pancreatic Adenocarcinoma Research Study Groups: Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine, Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine, Phase 2: nab-paclitaxel and gemcitabine alone
Pancreatic Adenocarcinoma Clinical Trial 2023: AVB-S6-500 (Batiraxcept) Highlights & Side Effects. Trial Name: NCT04983407 — Phase 1 & 2
AVB-S6-500 (Batiraxcept) (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04983407 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the cap for enrollees in this clinical research?

"This trial is seeking 80 suitable patients from two locations - the Perlmutter Cancer Center at NYU Langone Health in New york, and Oregon Health and Science University in Portland. Those meeting inclusion criteria are welcome to join this clinical investigation."

Answered by AI

What indications is batiraxcept most frequently employed to address?

"Batiraxcept is a medication frequently prescribed to manage the growth of secondary tumours and conditions such as locally advanced non-small cell lung cancer, metastatic bladder carcinoma, and urinary tract disorders."

Answered by AI

What concurrent investigations have been conducted on batiraxcept?

"Currently, 1112 clinical trials are exploring the effects of batiraxcept with 321 studies in their last phase. The greatest concentration of these experiments is located in Shanghai, though there are a total of 59388 sites worldwide running this research."

Answered by AI

Are there still available slots for participants in this clinical research study?

"Affirmative. According to clinicaltrials.gov, this investigation is in the process of recruitment which commenced on July 28th 2021; with updates provided as recently as February 21st 2022. The research aims to enrol 80 patients from 18 distinct medical centres."

Answered by AI

What are the paramount aims of this research project?

"This 12-month clinical trial will survey the anti-tumor activity of AVB-S6-500 combined with nab-paclitaxel and gemcitabine. Secondary objectives involve gauging overall survival, duration of response (DOR), along with pharmacokinetics such as apparent terminal half life (t1/2)."

Answered by AI

How many sites are managing this research study?

"This trial is being conducted in Perlmutter Cancer Center at NYU Langone Health, Oregon Health and Science University, Scripps MD Anderson Cancer Centre as well as 18 additional sites across the USA."

Answered by AI
~10 spots leftby Feb 2025