Status:
TERMINATED
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Lead Sponsor:
Aravive, Inc.
Conditions:
Clear Cell Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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, AVB-S6-500 in combination with cabozantinib and nivolumab and AVB-...
Eligibility Criteria
Inclusion
- Age 18 years or older
- Histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma confirmed by imaging. Phase 1b and Phase 2 Part A: has progressed on/after at least one front-line of treatment; Phase 2 Part B: No prior systemic treatment; Phase 2 Part C: not amenable to curative intent therapy.
- 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 bone marrow, liver and kidney function
- Life expectancy 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
- Received prior treatment with cabozantinib (Phase1b and Phase 2 Part A)
- Received prior treatment with nivolumab (Phase 2 Part B)
- Concurrent anti-cancer therapy or any other interventional treatment or other interventional research trial
- 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 pleural effusion, ascites etc that requires therapeutic intervention within 28 days prior to AVB-S6-500 administration
- Phase 2 Part A and Part B: 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
- Phase 2 Part B: Has active, known or suspected autoimmune disease, defined as requiring systemic treatment
- Active COVID-19, HIV, Hepatitis B or Hepatitis C virus.
Key Trial Info
Start Date :
February 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT04300140
Start Date
February 26 2021
End Date
August 14 2023
Last Update
October 30 2023
Active Locations (17)
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1
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
4
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201