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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
~17 spots leftby Jun 2025
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