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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights

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

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

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
~140
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
~9 spots leftby Jul 2025
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