Purpose

This is a Phase 1b/2 study of AVB-S6-500 designed to evaluate the safety and efficacy of AVB-S6-500 in combination with cabozantinib in subjects with advanced clear cell renal cell carcinoma (ccRCC) that have progressed on or after at least one prior line of treatment. The phase 1b portion of the study is open label and patients will receive AVB-S6-500+Cabozantinib in 3+3 dose escalation. The Phase 2 portion of the study is randomized, 2-arm, open-label study to compare efficacy and tolerability of AVB-S6-500+cabozantinib versus cabozantinib alone

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age 18 years or older - Histologically confirmed metastatic clear cell Renal Cell Carcinoma confirmed by imaging and has progressed on/after at least one front-line treatment regimen - Must have archived or fresh tissue biopsy for biomarker testing - Must have radiologic imaging with a computed tomography (CT) scan or magnetic resonance imaging (MRI) within 28 days of enrollment - Must have at least one measurable lesion according to RECIST 1.1 - ECOG performance status of 0-1 - Adequate gastrointestinal (GI), bone marrow, liver and kidney function - Life expectancy minimum of >12 weeks - At least 28 days between termination of prior major surgery or anticancer therapy or 14 days from last radiation therapy and administration of AVB-S6-500

Exclusion Criteria

  • Received prior treatment with cabozantinib - Concurrent anti-cancer therapy or any other interventional treatment or other interventional research trial - Significant cardiac disease history - History of prior malignancy within the past 3 years except adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the prostate, cervix or breast - Symptomatic CNS metastasis or metastases - Active GI disease that would impact absorption of cabozantinib - Nephrotic range proteinuria at screening - Evidence of active pleural effusion (ie, ascites, anasarca, etc) that requires therapeutic intervention within 28 days prior to AVB-S6-500 administration - Has had a major bleed in the last 3 months, uncontrolled hypertension despite treatment with Antihypertensives or is not appropriate for treatment with cabozantinib in the Investigator's opinion - Serious active infection requiring IV antibiotics and/or hospitalization at study entry - Has active, suspected, or previously documented autoimmune disease, defined as requiring systemic treatment - Active coronavirus disease 2019, human immunodeficiency virus, Hepatitis B or Hepatitis C virus.

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1b: AVB-S6-500+Cabo
  • Drug: AVB-S6-500
    AVB-S6-500 is experimental drug
  • Drug: Cabozantinib (Cabo)
    Cabo is active comparator
    Other names:
    • Cabometyx®
Experimental
Phase 2: AVB-S6-500+Cabo
  • Drug: AVB-S6-500
    AVB-S6-500 is experimental drug
  • Drug: Cabozantinib (Cabo)
    Cabo is active comparator
    Other names:
    • Cabometyx®
Experimental
Phase 2: Cabo alone
  • Drug: Cabozantinib (Cabo)
    Cabo is active comparator
    Other names:
    • Cabometyx®

Recruiting Locations

Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee 37232
Contact:
VICC Clinical Trials Reporting Program
800-811-8480

More Details

Status
Recruiting
Sponsor
Aravive, Inc.

Study Contact

Aravive Clinical Trials
936-355-1910
clinicaltrials@aravive.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.