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, 2-arm, open-label study to compare efficacy and
tolerability of AVB-S6-500+cabozantinib versus cabozantinib alone
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
Drug | Synonyms | Arms |
---|
AVB-S6-500 | | Phase 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
Name | Type | Description | Interventions |
---|
Phase 1b: AVB-S6-500+Cabo | Experimental | | - AVB-S6-500
- Cabozantinib (Cabo)
|
Phase 2: AVB-S6-500+Cabo | Experimental | | - AVB-S6-500
- Cabozantinib (Cabo)
|
Phase 2: Cabo alone | Experimental | | |
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
July 22, 2020