Kidney Cancer Clinical Trial

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

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-S6-500 monotherapy in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The phase 1b portion of the study is open label and patients with advanced ccRCC who had progressed on or after at least one prior line of treatment will receive AVB-S6-500 + cabozantinib. Two dose levels will be evaluated. The Phase 2 portion of the study is open-label 3-part study to evaluate efficacy and tolerability of AVB-S6-500 + cabozantinib, AVB-S6-500 + cabozantinib + nivolumab, and AVB-S6-500 alone.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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.

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

72

Study ID:

NCT04300140

Recruitment Status:

Terminated

Sponsor:

Aravive, Inc.

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There are 17 Locations for this study

See Locations Near You

University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore Maryland, 21201, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Comprehensive Cancer Care of Nevada
Las Vegas Nevada, 89169, United States
Roswell Park Cancer Institute
Buffalo New York, 14263, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10024, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Cleveland Clinic
Cleveland Ohio, 44195, United States
OU Health Stephenson Cancer Center
Oklahoma City Oklahoma, 73104, United States
University of Pennsylvania Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Allegheny Health Network
Pittsburgh Pennsylvania, 15212, United States
Hollings Cancer Center (HCC)
Charleston South Carolina, 29425, United States
Vanderbilt-Ingram Cancer Center (VICC)
Nashville Tennessee, 37232, United States
University of Texas Southwestern
Dallas Texas, 75390, United States
UT MD Anderson Cancer Center
Houston Texas, 77030, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 1

Estimated Enrollment:

72

Study ID:

NCT04300140

Recruitment Status:

Terminated

Sponsor:


Aravive, Inc.

How clear is this clinincal trial information?

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