Clinical Trials /

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

NCT04300140

Description:

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

Related Conditions:
  • Clear Cell Renal Cell Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: AVB500-RCC-003
  • NCT ID: NCT04300140

Conditions

  • Clear Cell Renal Cell Carcinoma

Interventions

DrugSynonymsArms
AVB-S6-500Phase 1b: AVB-S6-500+Cabo
Cabozantinib (Cabo)Cabometyx®Phase 1b: AVB-S6-500+Cabo

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

Trial Arms

NameTypeDescriptionInterventions
Phase 1b: AVB-S6-500+CaboExperimental
  • AVB-S6-500
  • Cabozantinib (Cabo)
Phase 2: AVB-S6-500+CaboExperimental
  • AVB-S6-500
  • Cabozantinib (Cabo)
Phase 2: Cabo aloneExperimental
  • Cabozantinib (Cabo)

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib
Time Frame:10 months
Safety Issue:
Description:Measured by dose limiting toxicities experienced in Phase 1b

Secondary Outcome Measures

Measure:Pharmacokinetics: AUC
Time Frame:30 months
Safety Issue:
Description:Area under the AVB-S6-500 concentration-time curve.
Measure:Pharmacokinetics: Cmax
Time Frame:30 months
Safety Issue:
Description:Maximum observed AVB-S6-500 concentration.
Measure:Pharmacokinetics: Tmax
Time Frame:30 months
Safety Issue:
Description:Time of maximum observed AVB-S6-500 concentration.
Measure:Pharmacokinetics: t1/2
Time Frame:30 months
Safety Issue:
Description:Apparent terminal half-life of AVB-S6-500.
Measure:Pharmacodynamic marker assessment
Time Frame:30 months
Safety Issue:
Description:Change from the baseline in GAS6 serum levels.
Measure:Anti-drug antibody (ADA) titers
Time Frame:30 months
Safety Issue:
Description:Change from baseline in ADA titer.
Measure:Objective response rate
Time Frame:30 months
Safety Issue:
Description: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.
Measure:Clinical benefit rate
Time Frame:30 months
Safety Issue:
Description:Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Measure:Duration of response (DOR)
Time Frame:30 months
Safety Issue:
Description:Measured from the date of partial or complete response to therapy until the cancer progresses.
Measure:Overall survival
Time Frame:60 months
Safety Issue:
Description:Time following the treatment until death.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Aravive, Inc.

Trial Keywords

  • Clear cell renal cell carcinoma
  • Renal cell carcinoma
  • Recurrent renal cell carcinoma
  • Kidney cancer
  • Kidney Neoplasms
  • Kidney Diseases
  • Urologic Neoplasms

Last Updated

July 26, 2021