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Clear Cell Renal Cell CarcinomaPhase 1/2NCT04300140

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

A Phase 1/2 study testing Batiraxcept, Cabozantinib (Cabo) and Nivolumab in people with Clear Cell Renal Cell Carcinoma, run by Aravive, Inc. at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Clear Cell Renal Cell Carcinoma
What is being tested?
Batiraxcept, Cabozantinib (Cabo) and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
17 sitesUnited States
Study dates
26 Feb 2021to 14 Aug 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Maryland Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Hollings Cancer Center (HCC)

    Charleston, South Carolina, 29425

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • Comprehensive Cancer Care of Nevada

    Las Vegas, Nevada, 89169

  • Froedtert Hospital and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Vanderbilt-Ingram Cancer Center (VICC)

    Nashville, Tennessee, 37232

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10024

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Allegheny Health Network

    Pittsburgh, Pennsylvania, 15212

Other trials in United States

About this study

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

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.

Being tested
Batiraxcept, Cabozantinib (Cabo), Nivolumab
Keywords
Clear cell renal cell carcinoma, Renal cell carcinoma, Recurrent renal cell carcinoma, Kidney cancer, Kidney Neoplasms, Kidney Diseases, Urologic Neoplasms
Medical subject headings
Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases, Urologic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BatiraxceptDrug

    Also called AVB-S6-500

    Batiraxcept is experimental drug

  • Cabozantinib (Cabo)Drug

    Also called Cabometyx®

    Cabozantinib is standard of care as monotherapy and in combination with nivolumab in ccRCC

  • NivolumabDrug

    Also called Opdivo®

    Nivolumab is standard of care in the first line treatment of ccRCC

Study groups in NCT04300140
Study groupRoleWhat they receive
Phase 1b: Batiraxcept + cabozantinibExperimentalTwo dose levels of batiraxcept administered Q2W (once every two weeks) in combination with QD (once a day) cabozantinib will be evaluated.
Receives: Drug: Batiraxcept; Drug: Cabozantinib (Cabo)
Phase 2 Part A: batiraxcept + cabozantinibExperimentalOne dose level of batiraxcept administered Q2W in combination with QD cabozantinib will be evaluated.
Receives: Drug: Batiraxcept; Drug: Cabozantinib (Cabo)
Phase 2 Part B: batiraxcept + cabozantinib + nivolumabExperimentalOne dose level of batiraxcept administered Q2W in combination with QD cabozantinib and nivolumab.
Receives: Drug: Batiraxcept; Drug: Cabozantinib (Cabo); Drug: Nivolumab
Phase 2 Part C: batiraxcept aloneExperimentalOne dose level of batiraxcept administered Q2W will be evaluated.
Receives: Drug: Batiraxcept

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 10 months

  2. Identify the recommended Phase 2 dose of AVB-S6-500 in combination with cabozantinib

    Measured by dose limiting toxicities experienced in Phase 1b

    Measured: 10 months

  3. 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.

    Measured: 30 months

  4. 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.

    Measured: 30 months

  5. 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.

    Measured: 30 months

  6. 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.

    Measured: 30 months

  7. 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.

    Measured: 30 months

  8. 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.

    Measured: 30 months

  9. 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.

    Measured: 60 months

Secondary outcomes (16)

  1. Pharmacokinetics: AUC

    Area under the AVB-S6-500 concentration-time curve.

    Measured: 30 months

  2. Pharmacokinetics: Cmax

    Maximum observed AVB-S6-500 concentration.

    Measured: 30 months

  3. Pharmacokinetics: Tmax

    Time of maximum observed AVB-S6-500 concentration.

    Measured: 30 months

  4. Pharmacokinetics: t1/2

    Apparent terminal half-life of AVB-S6-500.

    Measured: 30 months

  5. Pharmacodynamic marker assessment

    Change from the baseline in GAS6 serum levels.

    Measured: 30 months

  6. Anti-drug antibody (ADA) titers

    Change from baseline in ADA titer.

    Measured: 30 months

  7. 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.

    Measured: 30 months

  8. 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.

    Measured: 30 months

  9. 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.

    Measured: 60 months

  10. 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.

    Measured: 30 months

  11. 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.

    Measured: 30 months

  12. 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.

    Measured: 30 months

  13. 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.

    Measured: 30 months

  14. 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.

    Measured: 60 months

  15. 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

    Measured: 30 months

  16. 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

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2020
  2. Study start26 Feb 2021
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Why it stopped: Due to business reasons

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04300140
Sponsor's protocol ID
AVB500-RCC-003
Status last verified
Oct 2023
First submitted
5 Mar 2020
Last updated
30 Oct 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Beckermann KE, Shah NJ, Campbell MT, Haas NB, Nelson A, Ornstein MC, Mao S, Keshava-Prasad HS, Hammers H, Gao X, Gourdin T, George S, Hoimes CJ, Hussain A, Jonasch E, Rini BI, Voss MH. Phase 1b/2 study of batiraxcept alone and in combination with cabozantinib with or without nivolumab for advanced clear cell renal cell carcinoma. Oncologist. 2025 Jun 4;30(6):oyaf138. doi: 10.1093/oncolo/oyaf138.

    PubMed 40549043

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Batiraxcept, Cabozantinib (Cabo) and Nivolumab in people with Clear Cell Renal Cell Carcinoma, run by Aravive, Inc. at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Due to business reasons). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events in Phase 1b as graded by NCI-CTCAE version 5.0 (time frame: 10 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04300140, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.

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