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Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab for Cancer

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs)

Expansion Stage: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the Investigator

Secondary outcome measures

Dose-finding Stage: Concentration of study treatments (zanzalintinib and AB521) in plasma at specified time points

Dose-finding Stage: Number of participants with adverse events (AEs), including serious adverse events (SAEs) and immune-mediated adverse events (imAEs)

Dose-finding Stage: Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the Investigator

+5 more

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

~4750

AB521

2023

Completed Phase 1

~100

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arcus Biosciences, Inc.Industry Sponsor

41 Previous Clinical Trials

5,926 Total Patients Enrolled

ExelixisLead Sponsor

117 Previous Clinical Trials

19,411 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants involved in this research investigation?

"Indeed, the information available on clinicaltrials.gov confirms that this clinical trial is currently in the recruitment phase. The trial was initially posted on January 1st, 2024 and its most recent update occurred on January 3rd, 2024. A total of 140 patients are sought to participate in this study across a single site."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"According to the information provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was first posted for recruitment purposes on January 1st, 2024 and has been recently updated as of January 3rd, 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)

2024. "Study of Zanzalintinib (XL092) + AB521 and Zanzalintinib + AB521 + Nivolumab in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Other Advanced Solid Tumors (STELLAR-009)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06191796.

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