Clinical Trials /

Efficacy and Safety Study of AVB-S6-500 in Patients With 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 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, 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:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety Study of AVB-S6-500 in Patients With 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 That 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 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, 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 stage IV clear cell Renal Cell Carcinoma and has progressed
             on/after or was intolerant to front-line treatment

          -  Must have radiologic imaging with a computerized tomography (CT) scan or magnetic
             resonance imaging (MRI) within 4 weeks 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 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 trial

          -  Significant cardiac disease history

          -  Has other prior or concurrent 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

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

Primary Outcome Measures

Measure:Incidence of Adverse Events (AEs)
Time Frame:9 months
Safety Issue:
Description:Measured by the number of patients with AEs in Phase 1 portion of the study.

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 response to therapy relative to baseline as assessed per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
Measure:Disease control 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:Not yet recruiting
Lead Sponsor:Aravive, Inc.

Trial Keywords

  • Clear cell renal cell carcinoma
  • Renal cell carcinoma
  • Kidney cancer

Last Updated

March 5, 2020