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Safety and Efficacy Study of AVB-S6-500 in Patients With Advanced Clear Cell Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT04300140
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : March 19, 2021
Sponsor:
Information provided by (Responsible Party):
Aravive, Inc.

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 in subjects with advanced clear cell renal cell carcinoma (ccRCC) that have received front-line 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 or disease Intervention/treatment Phase
Clear Cell Renal Cell Carcinoma Drug: AVB-S6-500 Drug: Cabozantinib (Cabo) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2, Randomized, Study of AVB-S6-500 in Combination With Cabozantinib Versus Cabozantinib Alone in Patients With Advanced Clear Cell Renal Cell Carcinoma Who Have Received Front-Line Treatment
Actual Study Start Date : February 26, 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : July 2023


Arm Intervention/treatment
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 Name: 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 Name: Cabometyx®

Experimental: Phase 2: Cabo alone Drug: Cabozantinib (Cabo)
Cabo is active comparator
Other Name: Cabometyx®




Primary Outcome Measures :
  1. Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib [ Time Frame: 10 months ]
    Measured by dose limiting toxicities experienced in Phase 1b

  2. Anti-tumor activity of AVB-S6-500 in combination with Cabozantinib [ Time Frame: 30 months ]
    Measured by progression free survival (PFS) in patients receiving AVB-S6-500+Cabo versus patients receiving Cabo alone in Phase 2


Secondary Outcome Measures :
  1. Pharmacokinetics: AUC [ Time Frame: 30 months ]
    Area under the AVB-S6-500 concentration-time curve.

  2. Pharmacokinetics: Cmax [ Time Frame: 30 months ]
    Maximum observed AVB-S6-500 concentration.

  3. Pharmacokinetics: Tmax [ Time Frame: 30 months ]
    Time of maximum observed AVB-S6-500 concentration.

  4. Pharmacokinetics: t1/2 [ Time Frame: 30 months ]
    Apparent terminal half-life of AVB-S6-500.

  5. Pharmacodynamic marker assessment [ Time Frame: 30 months ]
    Change from the baseline in GAS6 serum levels.

  6. Anti-drug antibody (ADA) titers [ Time Frame: 30 months ]
    Change from baseline in ADA titer.

  7. Objective response rate [ Time Frame: 30 months ]
    Proportion of subjects who have a partial or complete confirmed response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

  8. Clinical benefit rate [ Time Frame: 30 months ]
    Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.

  9. Duration of response (DOR) [ Time Frame: 30 months ]
    Measured from the date of partial or complete response to therapy until the cancer progresses.

  10. Overall survival [ Time Frame: 60 months ]
    Time following the treatment until death.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 years or older
  • Histologically confirmed metastatic clear cell Renal Cell Carcinoma and has progressed on/after one front-line treatment regimen
  • Must have archived or fresh tissue biopsy for biomarker testing
  • Must have radiologic imaging with a computerized tomography (CT) scan or magnetic resonance imaging (MRI) within 21 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 14 days between termination of prior anticancer or radiation therapy and administration of AVB-S6-500

Exclusion Criteria:

  • Received prior treatment with cabozantinib
  • Currently being treated with concurrent anti-cancer therapy or any other interventional treatment or other interventional research trial
  • Significant cardiac disease history
  • Has other 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
  • Active intervention for pleural effusion (ie, thoracentesis within the past month)
  • 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
  • Has known human immune deficiency (HIV) syndrome, hepatitis B, or hepatitis C

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300140


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

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center Not yet recruiting
Boston, Massachusetts, United States, 02215
United States, Nevada
Comprehensive Cancer Care of Nevada Recruiting
Las Vegas, Nevada, United States, 89169
United States, New York
Memorial Sloan Kettering Cancer Center Not yet recruiting
New York, New York, United States, 10024
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania Abramson Cancer Center Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Allegheny Health Network Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact    412-330-6151    ClinicalTrials@AHN.ORG   
United States, Tennessee
Vanderbilt-Ingram Cancer Center (VICC) Recruiting
Nashville, Tennessee, United States, 37232
Contact: VICC Clinical Trials Reporting Program    800-811-8480      
United States, Texas
University of Texas Southwestern Not yet recruiting
Dallas, Texas, United States, 75390
Contact: Marcella Aguilar    214-648-1479    marcella.aguilar@utsouthwestern.edu   
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Aravive, Inc.
Investigators
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Study Director: Vanessa Esquibel Aravive, Inc.
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Responsible Party: Aravive, Inc.
ClinicalTrials.gov Identifier: NCT04300140    
Other Study ID Numbers: AVB500-RCC-003
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: March 19, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aravive, Inc.:
Clear cell renal cell carcinoma
Renal cell carcinoma
Recurrent renal cell carcinoma
Kidney cancer
Kidney Neoplasms
Kidney Diseases
Urologic Neoplasms
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases