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 |
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Recruitment Status :
Recruiting
First Posted : March 9, 2020
Last Update Posted : March 19, 2021
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Sponsor:
Aravive, Inc.
Information provided by (Responsible Party):
Aravive, Inc.
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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 |
| 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 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Cabozantinib
| 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 :
- 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
- 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 :
- Pharmacokinetics: AUC [ Time Frame: 30 months ]Area under the AVB-S6-500 concentration-time curve.
- Pharmacokinetics: Cmax [ Time Frame: 30 months ]Maximum observed AVB-S6-500 concentration.
- Pharmacokinetics: Tmax [ Time Frame: 30 months ]Time of maximum observed AVB-S6-500 concentration.
- Pharmacokinetics: t1/2 [ Time Frame: 30 months ]Apparent terminal half-life of AVB-S6-500.
- Pharmacodynamic marker assessment [ Time Frame: 30 months ]Change from the baseline in GAS6 serum levels.
- Anti-drug antibody (ADA) titers [ Time Frame: 30 months ]Change from baseline in ADA titer.
- 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.
- Clinical benefit rate [ Time Frame: 30 months ]Proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
- Duration of response (DOR) [ Time Frame: 30 months ]Measured from the date of partial or complete response to therapy until the cancer progresses.
- 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
| Contact: Aravive Clinical Trials | 936-355-1910 | clinicaltrials@aravive.com |
Locations
| 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
| Study Director: | Vanessa Esquibel | Aravive, Inc. |
| 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 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Aravive, Inc.:
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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 |