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

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aravive, Inc.

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.