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Zanzalintinib Combinations for Renal Cell Carcinoma

Phase 1 & 2
Recruiting
Research Sponsored by Exelixis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants with unresectable advanced or metastatic disease or 1L or 2L+ clear cell Renal cell carcinoma
Have not received HIF-2α targeted therapy previously
Must not have
Administration of a live, attenuated vaccine within 30 days prior to enrollment
Radiation therapy for bone metastases within 2 weeks, any other radiation therapy within 4 weeks before first dose of study treatment. Participants with clinically-relevant ongoing complications from prior radiation therapy are not eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

This trial is looking at the safety and effectiveness of a drug called zanzalintinib in combination with AB521 or AB521 plus nivolumab for people with advanced kidney cancer or other

Who is the study for?
This trial is for adults with advanced clear cell renal cell carcinoma (ccRCC) or other solid tumors. Participants should not have had previous treatments that are similar to the drugs in this study and must be able to perform daily activities with minimal assistance.
What is being tested?
The trial is testing the safety and initial effectiveness of a new drug combo: Zanzalintinib with AB521, and Zanzalintinib with AB521 plus Nivolumab. It's looking at what doses are safe, how well patients tolerate the treatment, how their bodies process it, and if it works against cancer.
What are the potential side effects?
Possible side effects include fatigue, nausea, skin reactions, changes in liver function tests, high blood pressure, immune-related conditions like inflammation of organs or glands due to Nivolumab as part of the triplet therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney cancer cannot be removed by surgery and is advanced.
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I have never been treated with HIF-2α inhibitors.
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My oxygen levels while moving are 92% or higher.
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I am able to care for myself but may not be able to do active work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 30 days.
Select...
I haven't had radiation for bone metastases in the last 2 weeks or any other radiation in the last 4 weeks.
Select...
I have been treated with HIF-2α inhibitors or zanzalintinib before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

4Treatment groups
Experimental Treatment
Group I: Expansion Cohort 2: zanzalintinib + AB521 + nivolumabExperimental Treatment3 Interventions
Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab
Group II: Expansion Cohort 1: Zanzalintinib + AB521Experimental Treatment2 Interventions
Participants with ccRCC will receive zanzalintinib + AB521
Group III: Dose-finding Cohort B: zanzalintinib + AB521 + nivolumabExperimental Treatment3 Interventions
Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab
Group IV: Dose-finding Cohort A: Zanzalintinib + AB521Experimental Treatment2 Interventions
Participants with solid tumors will receive zanzalintinib + AB521
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
AB521
2023
Completed Phase 1
~100

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Industry Sponsor
41 Previous Clinical Trials
6,451 Total Patients Enrolled
ExelixisLead Sponsor
119 Previous Clinical Trials
19,779 Total Patients Enrolled
~91 spots leftby Jan 2026
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