batiraxcept for Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Adenocarcinoma+1 More
batiraxcept - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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
  • Adenocarcinoma

Treatment Effectiveness

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: 60 months

12 months
Anti-tumor activity of AVB-S6-500 in combination with nab-paclitaxel and gemcitabine in Phase 1b portion of the study
Incidence of adverse events (AEs)
30 months
Anti-drug antibody (ADA) titers
Anti-tumor activity of AVB-S6-500 in combination with nab-paclitaxel and gemcitabine in Phase 2 portion of the study
Disease control rate
Duration of response (DOR)
Tumor Markers
Pharmacokinetics: AUC
Pharmacokinetics: Cmax
Pharmacokinetics: Tmax
Pharmacokinetics: t1/2
60 months
Overall survival

Trial Safety

Trial Design

3 Treatment Groups

Phase 2: nab-paclitaxel and gemcitabine alone
1 of 3
Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabine
1 of 3
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabine
1 of 3

Active Control

Experimental Treatment

80 Total Participants · 3 Treatment Groups

Primary Treatment: batiraxcept · No Placebo Group · Phase 1 & 2

Phase 1b: batiraxcept+ nab-paclitaxel and gemcitabineExperimental Group · 3 Interventions: batiraxcept, Gemcitabine, Nab paclitaxel · Intervention Types: Drug, Drug, Drug
Phase 2: batiraxcept+ nab-paclitaxel and gemcitabineExperimental Group · 3 Interventions: batiraxcept, Gemcitabine, Nab paclitaxel · Intervention Types: Drug, Drug, Drug
Phase 2: nab-paclitaxel and gemcitabine aloneActiveComparator Group · 2 Interventions: Gemcitabine, Nab paclitaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 60 months

Who is running the clinical trial?

Aravive, Inc.Lead Sponsor
7 Previous Clinical Trials
546 Total Patients Enrolled
Amy FrankeStudy DirectorAravive, Inc.
3 Previous Clinical Trials
483 Total Patients Enrolled
Eduardo Pennella, MDStudy DirectorAravive, Inc.
3 Previous Clinical Trials
930 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must have radiologic imaging with a CT scan or MRI within 22 days of study entry.
You have had surgery and are recovering adequately from your surgery.
You must be between the ages of 18 and 50 years old.
You have a performance status of 0-1.
You have a life expectancy of at least 12 weeks.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 4th, 2021

Last Reviewed: November 9th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.