Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
NCT ID: NCT04300140
Last Updated: 2023-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1/PHASE2
72 participants
INTERVENTIONAL
2021-02-26
2023-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase 1b: Batiraxcept + cabozantinib
Two dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.
Batiraxcept
Batiraxcept is experimental drug
Cabozantinib (Cabo)
Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC
Phase 2 Part A: batiraxcept + cabozantinib
One dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.
Batiraxcept
Batiraxcept is experimental drug
Cabozantinib (Cabo)
Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC
Phase 2 Part B: batiraxcept + cabozantinib + nivolumab
One dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.
Batiraxcept
Batiraxcept is experimental drug
Cabozantinib (Cabo)
Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC
Nivolumab
Nivolumab is standard of care in the first line treatment of ccRCC
Phase 2 Part C: batiraxcept alone
One dose level of batiraxcept administered Q2W will be evaluated.
Batiraxcept
Batiraxcept is experimental drug
Interventions
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Batiraxcept
Batiraxcept is experimental drug
Cabozantinib (Cabo)
Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC
Nivolumab
Nivolumab is standard of care in the first line treatment of ccRCC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Aravive, Inc.
INDUSTRY
Responsible Party
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Locations
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University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Comprehensive Cancer Care of Nevada
Las Vegas, Nevada, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center (HCC)
Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
UT MD Anderson Cancer Center
Houston, Texas, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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References
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Beckermann KE, Shah NJ, Campbell MT, Haas NB, Nelson A, Ornstein MC, Mao S, Keshava-Prasad HS, Hammers H, Gao X, Gourdin T, George S, Hoimes CJ, Hussain A, Jonasch E, Rini BI, Voss MH. Phase 1b/2 study of batiraxcept alone and in combination with cabozantinib with or without nivolumab for advanced clear cell renal cell carcinoma. Oncologist. 2025 Jun 4;30(6):oyaf138. doi: 10.1093/oncolo/oyaf138.
Other Identifiers
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AVB500-RCC-003
Identifier Type: -
Identifier Source: org_study_id
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