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Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid TumorsPhase 1NCT06191796

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)

A Phase 1 study testing zanzalintinib, AB521 and Nivolumab in people with Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors, run by Exelixis at 14 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

The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zanzalintinib, AB521 and Nivolumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
14 sitesUnited States
Study dates
25 Jan 2024to 12 May 2025
Phase
Phase 1
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

  • Participants with a).unresectable advanced or metastatic solid tumor; b). unresectable advanced or metastatic clear cell renal cell carcinoma and no prior anticancer therapy; or c). unresectable advanced or metastatic clear cell renal cell carcinoma and has received at least one prior anticancer therapy.
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1; Eisenhauer et al, 2009) as determined by the Investigator.
  • For all participants, archival tumor tissue material should be obtained; if archival tissue is not available or is older than 2 years, then a fresh biopsy should be obtained, if medically feasible. Specific requirements for tumor tissue samples will be described in the Laboratory Manual.
  • Recovery to baseline or ≤ Grade 1 per Common Terminology Criteria for Adverse Events (CTCAE) v5 from AE(s) related to any prior treatments unless AE(s) are deemed clinically nonsignificant by the Investigator and/or stable on supportive therapy.
  • Karnofsky Performance Status (KPS) ≥70%.
  • Screening ambulatory oxygen saturation (SpO2) ≥92%.
  • Screening left ventricular ejection fraction (LVEF) above the institutional lower limit of normal.

Who cannot join

  • Participants who have been previously treated with a HIF-2α targeted therapy and/or zanzalintinib.
  • 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.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before first dose of study treatment.
  • Concomitant anticoagulation with oral anticoagulants except for a). prophylactic use of low-dose aspirin for cardioprotection or low dose low molecular weight heparins (LMWH) or b). therapeutic doses of LMWH or specified direct factor Xa inhibitors.
  • Administration of a live, attenuated vaccine within 30 days prior to enrollment.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Exelixis Site #8

    Los Angeles, California, 90033

  • Exelixis Site #12

    Madison, Wisconsin, 53792

  • Exelixis Site #9

    Miami, Florida, 33176

  • Exelixis Clinical Site #2

    Nashville, Tennessee, 37203

  • Exelixis Clinical Site #3

    New Hyde Park, New York, 11776

  • Exelixis Site #14

    New York, New York, 10028

  • Exelixis Clinical Site #1

    Orlando, Florida, 32804

  • Exelixis Clinical Site #16

    Salt Lake City, Utah, 84112

  • Exelixis Site #6

    Scarborough, Maine, 04074

  • Exelixis Site #13

    Shirley, New York, 11987

  • Exelixis Site #4

    Spokane, Washington, 99208

  • Exelixis Site #5

    St Louis, Missouri, 63110

  • Exelixis Site #11

    Tampa, Florida, 33612

  • Exelixis Site #15

    The Bronx, New York, 10469

Other trials in United States

About this study

Official title: A Phase 1b/2 Dose-finding and Expansion Study Evaluating the Safety and Efficacy of Zanzalintinib (XL092) Combined With Either AB521 or AB521 Plus Nivolumab in Subjects With Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors.

The goal of this clinical trial is to learn about the safety and preliminary antitumor activity of zanzalintinib in combination with AB521 (doublet) and in combination with AB521 plus nivolumab (triplet) in participants with advanced ccRCC or other advanced solid tumors. The main questions it aims to answer are:

  • The recommended doses (RDs)
  • The safety and tolerability
  • The PK and the preliminary efficacy
Being tested
zanzalintinib, AB521, Nivolumab

What participants receive

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

  • zanzalintinibDrug

    Also called XL092

    Specified doses on specified days

  • AB521Drug

    Specified doses on specified days

  • NivolumabBiological

    Also called OPDIVO®

    Specified doses on specified days

Study groups in NCT06191796
Study groupRoleWhat they receive
Dose-finding Cohort A: Zanzalintinib + AB521ExperimentalParticipants with solid tumors will receive zanzalintinib + AB521
Receives: Drug: zanzalintinib; Drug: AB521
Dose-finding Cohort B: zanzalintinib + AB521 + nivolumabExperimentalParticipants with ccRCC will receive zanzalintinib + AB521 + nivolumab
Receives: Drug: zanzalintinib; Drug: AB521; Biological: Nivolumab
Expansion Cohort 1: Zanzalintinib + AB521ExperimentalParticipants with ccRCC will receive zanzalintinib + AB521
Receives: Drug: zanzalintinib; Drug: AB521
Expansion Cohort 2: zanzalintinib + AB521 + nivolumabExperimentalParticipants with ccRCC will receive zanzalintinib + AB521 + nivolumab
Receives: Drug: zanzalintinib; Drug: AB521; Biological: Nivolumab

What is being measured

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

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

Secondary outcomes (8)

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

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

    Measured: Up to 24 months

  5. Expansion Stage: Duration of response (DOR) per RECIST 1.1 as assessed by the Investigator

    Measured: Up to 24 months

  6. Expansion Stage: Progression-free survival (PFS) per RECIST 1.1 as assessed by the Investigator

    Measured: Up to 24 months

  7. Expansion Stage: Overall survival (OS)

    Measured: Up to 24 months

  8. Expansion Stage: Concentration of study treatments (zanzalintinib and AB521) in plasma at specified time points

    Measured: Up to 24 months

Timeline

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

  1. First posted5 Jan 2024
  2. Study start25 Jan 2024
  3. Primary completion12 May 2025
  4. Study completion12 May 2025

Why it stopped: The study was terminated prior to starting the Phase 2 portion due to a business decision.

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
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06191796
Sponsor's protocol ID
XL092-009
Status last verified
Jun 2025
First submitted
19 Dec 2023
Last updated
12 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing zanzalintinib, AB521 and Nivolumab in people with Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors, run by Exelixis at 14 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 7 inclusion and 6 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 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 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.

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: The study was terminated prior to starting the Phase 2 portion due to a business decision.). 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?

Dose-finding Stage: Number of participants with dose-limiting toxicities (DLTs) (time frame: Up to 24 months). The study lists 2 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 NCT06191796.

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 12 Jun 2025.

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