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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Aravive, Inc.
Study ID
NCT04300140
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Clear Cell Renal Cell Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Batiraxcept — DRUG
    Batiraxcept is experimental drug
  • Cabozantinib (Cabo) — DRUG
    Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC
  • Nivolumab — DRUG
    Nivolumab is standard of care in the first line treatment of ccRCC

Study Details

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.

Key Dates

Start date
Feb 26, 2021
Status verified
Oct 2023
Primary completion
Aug 14, 2023
Completion
Aug 14, 2023

Study Design

Enrollment
72 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1b: Batiraxcept + cabozantinib
    Two dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.
  • Experimental: Phase 2 Part A: batiraxcept + cabozantinib
    One dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.
  • Experimental: Phase 2 Part B: batiraxcept + cabozantinib + nivolumab
    One dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.
  • Experimental: Phase 2 Part C: batiraxcept alone
    One dose level of batiraxcept administered Q2W will be evaluated.

Primary Outcome Measure

Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0 [ Time Frame: 10 months ]

Locations (17)

FacilityCityStateZIPSite coordinators
University of Maryland Greenebaum Comprehensive Cancer CenterBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02114-
Karmanos Cancer InstituteDetroitMichigan48201-
Comprehensive Cancer Care of NevadaLas VegasNevada89169-
Roswell Park Cancer InstituteBuffaloNew York14263-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10024-
Duke University Medical CenterDurhamNorth Carolina27710-
Cleveland ClinicClevelandOhio44195-
OU Health Stephenson Cancer CenterOklahoma CityOklahoma73104-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Allegheny Health NetworkPittsburghPennsylvania15212-
Hollings Cancer Center (HCC)CharlestonSouth Carolina29425-
Vanderbilt-Ingram Cancer Center (VICC)NashvilleTennessee37232-
University of Texas SouthwesternDallasTexas75390-
UT MD Anderson Cancer CenterHoustonTexas77030-
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Baltimore, MD

By research site
University of Maryland Greenebaum Comprehensive Cancer Center· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAKarmanos Cancer Institute· Detroit, MIComprehensive Cancer Care of Nevada· Las Vegas, NVRoswell Park Cancer Institute· Buffalo, NY

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