search
Back to results

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

Primary Purpose

Clear Cell Renal Cell Carcinoma

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Batiraxcept
Cabozantinib (Cabo)
Nivolumab
Sponsored by
Aravive, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Clear Cell Renal Cell Carcinoma focused on measuring Clear cell renal cell carcinoma, Renal cell carcinoma, Recurrent renal cell carcinoma, Kidney cancer, Kidney Neoplasms, Kidney Diseases, Urologic Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 18 years or older
  • Histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma confirmed by imaging. Phase 1b and Phase 2 Part A: has progressed on/after at least one front-line of treatment; Phase 2 Part B: No prior systemic treatment; Phase 2 Part C: not amenable to curative intent therapy.
  • 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 bone marrow, liver and kidney function
  • Life expectancy 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 (Phase1b and Phase 2 Part A)
  • Received prior treatment with nivolumab (Phase 2 Part B)
  • Concurrent anti-cancer therapy or any other interventional treatment or other interventional research trial
  • 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 pleural effusion, ascites etc that requires therapeutic intervention within 28 days prior to AVB-S6-500 administration
  • Phase 2 Part A and Part B: 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
  • Phase 2 Part B: Has active, known or suspected autoimmune disease, defined as requiring systemic treatment
  • Active COVID-19, HIV, Hepatitis B or Hepatitis C virus.

Sites / Locations

  • University of Maryland Greenebaum Comprehensive Cancer Center
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Karmanos Cancer Institute
  • Comprehensive Cancer Care of Nevada
  • Roswell Park Cancer Institute
  • Memorial Sloan Kettering Cancer Center
  • Duke University Medical Center
  • Cleveland Clinic
  • OU Health Stephenson Cancer Center
  • University of Pennsylvania Abramson Cancer Center
  • Allegheny Health Network
  • Hollings Cancer Center (HCC)
  • Vanderbilt-Ingram Cancer Center (VICC)
  • University of Texas Southwestern
  • UT MD Anderson Cancer Center
  • Froedtert Hospital and the Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Phase 1b: Batiraxcept + cabozantinib

Phase 2 Part A: batiraxcept + cabozantinib

Phase 2 Part B: batiraxcept + cabozantinib + nivolumab

Phase 2 Part C: batiraxcept alone

Arm Description

Two dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.

One dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.

One dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.

One dose level of batiraxcept administered Q2W will be evaluated.

Outcomes

Primary Outcome Measures

Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0
Safety and tolerability of AVB-S6-500 in combination with cabozantinib.
Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib
Measured by dose limiting toxicities experienced in Phase 1b
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (ORR)
Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. ORR is 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.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (ORR)
Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib + nivolumab in Phase 2 Part B. ORR is 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.
Anti-tumor activity of AVB-S6-500 alone (ORR)
Measured by objective response rate (ORR) in patients receiving AVB-S6-500 in Phase 2 Part C. ORR is 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.
Anti-tumor activity of AVB-S6-500 alone (DOR)
Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 2 Part C. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.
Anti-tumor activity of AVB-S6-500 alone (CBR)
Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 in Phase 2 Part C. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Anti-tumor activity of AVB-S6-500 alone (PFS)
Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 2 Part C. PFS is the time from treatment until radiological disease progression or death.
Anti-tumor activity of AVB-S6-500 alone (OS)
Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 2 Part C. OS is the time from the start of the treatment until death.

Secondary Outcome Measures

Pharmacokinetics: AUC
Area under the AVB-S6-500 concentration-time curve.
Pharmacokinetics: Cmax
Maximum observed AVB-S6-500 concentration.
Pharmacokinetics: Tmax
Time of maximum observed AVB-S6-500 concentration.
Pharmacokinetics: t1/2
Apparent terminal half-life of AVB-S6-500.
Pharmacodynamic marker assessment
Change from the baseline in GAS6 serum levels.
Anti-drug antibody (ADA) titers
Change from baseline in ADA titer.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (CBR)
Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (DOR)
Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (OS)
Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. OS is the time from the start of the treatment until death.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (PFS)
Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A, PFS is the time from treatment until radiological disease progression or death.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (DOR)
Measured by duration of response (DOR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (CBR)
Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (PFS)
Measured by progression-free survival (PFS) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. PFS is the time from treatment until radiological disease progression or death.
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (OS)
Measured by overall survival (OS) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. OS is the time from the start of the treatment until death.
Incidence of adverse events in Phase 2 Part C as graded by NCI-CTCAE version 5.0
Safety and tolerability of AVB-S6-500 alone
Incidence of adverse events in Phase 2 Part B as graded by NCI-CTCAE version 5.0
Safety and tolerability of AVB-S6-500 in combination with cabozantinib and nivolumab

Full Information

First Posted
March 5, 2020
Last Updated
January 17, 2023
Sponsor
Aravive, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT04300140
Brief Title
Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Official Title
A Phase 1b/2 Study Of AVB-S6-500 In Combination With Cabozantinib, AVB-S6-500 In Combination With Cabozantinib and Nivolumab, and AVB-S6-500 Monotherapy in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aravive, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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, AVB-S6-500 in combination with cabozantinib and nivolumab and AVB-S6-500 monotherapy in subjects with advanced or metastatic clear cell renal cell carcinoma (ccRCC). The phase 1b portion of the study is open label and patients with advanced ccRCC who had progressed on or after at least one prior line of treatment will receive AVB-S6-500 + cabozantinib. Two dose levels will be evaluated. The Phase 2 portion of the study is open-label 3-part study to evaluate efficacy and tolerability of AVB-S6-500 + cabozantinib, AVB-S6-500 + cabozantinib + nivolumab, and AVB-S6-500 alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clear Cell Renal Cell Carcinoma
Keywords
Clear cell renal cell carcinoma, Renal cell carcinoma, Recurrent renal cell carcinoma, Kidney cancer, Kidney Neoplasms, Kidney Diseases, Urologic Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Phase 1b: Batiraxcept + cabozantinib
Arm Type
Experimental
Arm Description
Two dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.
Arm Title
Phase 2 Part A: batiraxcept + cabozantinib
Arm Type
Experimental
Arm Description
One dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.
Arm Title
Phase 2 Part B: batiraxcept + cabozantinib + nivolumab
Arm Type
Experimental
Arm Description
One dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.
Arm Title
Phase 2 Part C: batiraxcept alone
Arm Type
Experimental
Arm Description
One dose level of batiraxcept administered Q2W will be evaluated.
Intervention Type
Drug
Intervention Name(s)
Batiraxcept
Other Intervention Name(s)
AVB-S6-500
Intervention Description
Batiraxcept is experimental drug
Intervention Type
Drug
Intervention Name(s)
Cabozantinib (Cabo)
Other Intervention Name(s)
Cabometyx®
Intervention Description
Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC
Intervention Type
Drug
Intervention Name(s)
Nivolumab
Other Intervention Name(s)
Opdivo®
Intervention Description
Nivolumab is standard of care in the first line treatment of ccRCC
Primary Outcome Measure Information:
Title
Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0
Description
Safety and tolerability of AVB-S6-500 in combination with cabozantinib.
Time Frame
10 months
Title
Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib
Description
Measured by dose limiting toxicities experienced in Phase 1b
Time Frame
10 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (ORR)
Description
Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. ORR is 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.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (ORR)
Description
Measured by objective response rate (ORR) in patients receiving AVB-S6-500 + cabozantinib + nivolumab in Phase 2 Part B. ORR is 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.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 alone (ORR)
Description
Measured by objective response rate (ORR) in patients receiving AVB-S6-500 in Phase 2 Part C. ORR is 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.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 alone (DOR)
Description
Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 2 Part C. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 alone (CBR)
Description
Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 in Phase 2 Part C. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 alone (PFS)
Description
Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 2 Part C. PFS is the time from treatment until radiological disease progression or death.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 alone (OS)
Description
Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 2 Part C. OS is the time from the start of the treatment until death.
Time Frame
60 months
Secondary Outcome Measure Information:
Title
Pharmacokinetics: AUC
Description
Area under the AVB-S6-500 concentration-time curve.
Time Frame
30 months
Title
Pharmacokinetics: Cmax
Description
Maximum observed AVB-S6-500 concentration.
Time Frame
30 months
Title
Pharmacokinetics: Tmax
Description
Time of maximum observed AVB-S6-500 concentration.
Time Frame
30 months
Title
Pharmacokinetics: t1/2
Description
Apparent terminal half-life of AVB-S6-500.
Time Frame
30 months
Title
Pharmacodynamic marker assessment
Description
Change from the baseline in GAS6 serum levels.
Time Frame
30 months
Title
Anti-drug antibody (ADA) titers
Description
Change from baseline in ADA titer.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (CBR)
Description
Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500 + cabozantinib in Phase 1b and Phase 2 Part A. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (DOR)
Description
Measured by duration of response (DOR) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (OS)
Description
Measured by overall survival (OS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A. OS is the time from the start of the treatment until death.
Time Frame
60 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib (PFS)
Description
Measured by progression-free survival (PFS) in patients receiving AVB-S6-500 in Phase 1b and Phase 2 Part A, PFS is the time from treatment until radiological disease progression or death.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (DOR)
Description
Measured by duration of response (DOR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. DOR is measured from the date of partial or complete response to therapy until the cancer progresses.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (CBR)
Description
Measured by clinical benefit rate (CBR) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. CBR is the proportion of subjects who have a complete or partial response to therapy or maintain stable disease.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (PFS)
Description
Measured by progression-free survival (PFS) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. PFS is the time from treatment until radiological disease progression or death.
Time Frame
30 months
Title
Anti-tumor activity of AVB-S6-500 in combination with cabozantinib and nivolumab (OS)
Description
Measured by overall survival (OS) in patients receiving AVB-S6-500, cabozantinib and nivolumab in Phase 2 Part B. OS is the time from the start of the treatment until death.
Time Frame
60 months
Title
Incidence of adverse events in Phase 2 Part C as graded by NCI-CTCAE version 5.0
Description
Safety and tolerability of AVB-S6-500 alone
Time Frame
30 months
Title
Incidence of adverse events in Phase 2 Part B as graded by NCI-CTCAE version 5.0
Description
Safety and tolerability of AVB-S6-500 in combination with cabozantinib and nivolumab
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 years or older Histologically confirmed advanced or metastatic clear cell Renal Cell Carcinoma confirmed by imaging. Phase 1b and Phase 2 Part A: has progressed on/after at least one front-line of treatment; Phase 2 Part B: No prior systemic treatment; Phase 2 Part C: not amenable to curative intent therapy. 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 bone marrow, liver and kidney function Life expectancy 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 (Phase1b and Phase 2 Part A) Received prior treatment with nivolumab (Phase 2 Part B) Concurrent anti-cancer therapy or any other interventional treatment or other interventional research trial 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 pleural effusion, ascites etc that requires therapeutic intervention within 28 days prior to AVB-S6-500 administration Phase 2 Part A and Part B: 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 Phase 2 Part B: Has active, known or suspected autoimmune disease, defined as requiring systemic treatment Active COVID-19, HIV, Hepatitis B or Hepatitis C virus.
Facility Information:
Facility Name
University of Maryland Greenebaum Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Comprehensive Cancer Care of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10024
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OU Health Stephenson Cancer Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Hollings Cancer Center (HCC)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center (VICC)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Froedtert Hospital and the Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Safety and Efficacy Study of AVB-S6-500 (Batiraxcept) in Patients With Advanced or Metastatic Clear Cell Renal Cell Carcinoma

We'll reach out to this number within 24 hrs