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Monoclonal Antibodies

Cabozantinib (Cabo) for Renal Cell Carcinoma

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

Study Summary

This trial is testing a new combination of drugs to treat ccRCC, which is the most common type of kidney cancer. The first part of the trial will test different doses of the new drug to see what is safe and effective. The second part of the trial will test the new drug combination in patients who have had other treatments.

Eligible Conditions
  • Clear Cell Renal Cell Carcinoma

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 AVB-S6-500 alone (CBR)
Anti-tumor activity of AVB-S6-500 alone (DOR)
Anti-tumor activity of AVB-S6-500 alone (ORR)
+6 more
Secondary outcome measures
Anti-drug antibody (ADA) titers
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (CBR)
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (DOR)
+13 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 Part C: batiraxcept aloneExperimental Treatment1 Intervention
One dose level of batiraxcept administered Q2W will be evaluated.
Group II: Phase 2 Part B: batiraxcept + cabozantinib + nivolumabExperimental Treatment3 Interventions
One dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.
Group III: Phase 2 Part A: batiraxcept + cabozantinibExperimental Treatment2 Interventions
One dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.
Group IV: Phase 1b: Batiraxcept + cabozantinibExperimental Treatment2 Interventions
Two dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Aravive, Inc.Lead Sponsor
8 Previous Clinical Trials
552 Total Patients Enrolled
Vanessa EsquibelStudy DirectorAravive, Inc.
Eduardo Pennella, MDStudy DirectorAravive, Inc.
4 Previous Clinical Trials
1,260 Total Patients Enrolled

Media Library

AVB-S6-500 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04300140 — Phase 1 & 2
Renal Cell Carcinoma Research Study Groups: Phase 2 Part B: batiraxcept + cabozantinib + nivolumab, Phase 2 Part C: batiraxcept alone, Phase 1b: Batiraxcept + cabozantinib, Phase 2 Part A: batiraxcept + cabozantinib
Renal Cell Carcinoma Clinical Trial 2023: AVB-S6-500 Highlights & Side Effects. Trial Name: NCT04300140 — Phase 1 & 2
AVB-S6-500 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04300140 — 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 trial's purpose?

"There are 830 active studies for Cabozantinib (Cabo) across 54 countries and 2596 cities. The first clinical trial for Cabozantinib (Cabo) was conducted in 2010 by Medarex, involving 127 participants. Since then, 303 trials have been completed, with the most recent ones still in progress."

Answered by AI

In how many different areas is this clinical trial taking place?

"There are 17 sites around the country enrolling patients for this clinical trial, so it may be helpful to choose the location nearest you to cut down on travel. Some of these sites include cities like Houston, Oklahoma City and Baltimore among others."

Answered by AI

Why was this research project designed in this way?

"The aim of this 10-month clinical trial is to evaluate the anti-tumor efficacy of AVB-S6-500 in combination with cabozantinib and nivolumab. The success of the intervention will be measured by ORR (Overall Response Rate). Additionally, Phase 1b and 2a patients' overall survival rates will be monitored as a secondary outcome measure. Lastly, another metric for determining the efficacy of AVB-S6-500 will be DOR (Duration of Response), or how long it takes for the cancer to progress following treatment."

Answered by AI

Are there any open slots for participants in this trial?

"According to the latest information available on clinicaltrials.gov, this trial is still recruiting patients. The study was originally posted on February 26th, 2021 and updated for the last time on August 8th, 2022."

Answered by AI

What other medical research studies have there been on Cabozantinib?

"830 medical studies are currently investigating the effects of Cabozantinib (Cabo), with 92 of those in Phase 3. Basel, BE is notably home to many trials for Cabozantinib (Cabo), but there are 43914 locations globally that have active clinical trials for this medication."

Answered by AI

What is the primary indication for Cabozantinib?

"While malignant neoplasms are the primary condition that can be treated with Cabozantinib (Cabo), this medication has also been shown to improve outcomes for patients struggling with unresectable melanoma, squamous cell carcinoma, and metastatic esophageal adenocarcinoma."

Answered by AI

How many study participants are you looking for in total?

"The sponsor, Aravive Inc., needs to enrol 80 eligible patients from various locations, including UT MD Anderson Cancer Center in Houston and OU Health Stephenson Cancer Center in Oklahoma City."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
2021. "Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04300140.
~18 spots leftby Apr 2025
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