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)

NCT ID: NCT06191796

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-25
• Study Completion Date: 2025-05-12

Brief 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. The main questions it aims to answer are:

• The recommended doses (RDs)
• The safety and tolerability
• The PK and the preliminary efficacy

Conditions

Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dose-finding Cohort A: Zanzalintinib + AB521

Participants with solid tumors will receive zanzalintinib + AB521

Group Type: EXPERIMENTAL

zanzalintinib

Intervention Type: DRUG

Specified doses on specified days

AB521

Intervention Type: DRUG

Specified doses on specified days

Dose-finding Cohort B: zanzalintinib + AB521 + nivolumab

Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab

Group Type: EXPERIMENTAL

zanzalintinib

Intervention Type: DRUG

Specified doses on specified days

AB521

Intervention Type: DRUG

Specified doses on specified days

Nivolumab

Intervention Type: BIOLOGICAL

Specified doses on specified days

Expansion Cohort 1: Zanzalintinib + AB521

Participants with ccRCC will receive zanzalintinib + AB521

Group Type: EXPERIMENTAL

zanzalintinib

Intervention Type: DRUG

Specified doses on specified days

AB521

Intervention Type: DRUG

Specified doses on specified days

Expansion Cohort 2: zanzalintinib + AB521 + nivolumab

Participants with ccRCC will receive zanzalintinib + AB521 + nivolumab

Group Type: EXPERIMENTAL

zanzalintinib

Intervention Type: DRUG

Specified doses on specified days

AB521

Intervention Type: DRUG

Specified doses on specified days

Nivolumab

Intervention Type: BIOLOGICAL

Specified doses on specified days

Interventions

zanzalintinib

Specified doses on specified days

Intervention Type: DRUG

AB521

Specified doses on specified days

Intervention Type: DRUG

Nivolumab

Specified doses on specified days

Intervention Type: BIOLOGICAL

Other Intervention Names

XL092; OPDIVO®

Eligibility Criteria

Inclusion Criteria

1. 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.

2. 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.

3. 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.

4. 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.

5. Karnofsky Performance Status (KPS) ≥70%.

6. Screening ambulatory oxygen saturation (SpO2) ≥92%.

7. Screening left ventricular ejection fraction (LVEF) above the institutional lower limit of normal.

Exclusion Criteria

1. Participants who have been previously treated with a HIF-2α targeted therapy and/or zanzalintinib.

2. 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.

3. 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.

4. 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.

5. Administration of a live, attenuated vaccine within 30 days prior to enrollment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arcus Biosciences, Inc.

INDUSTRY

Sponsor Role: collaborator

Exelixis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Exelixis Site #8

Los Angeles, California, United States

Exelixis Site #9

Miami, Florida, United States

Exelixis Clinical Site #1

Orlando, Florida, United States

Exelixis Site #11

Tampa, Florida, United States

Exelixis Site #6

Scarborough, Maine, United States

Exelixis Site #5

St Louis, Missouri, United States

Exelixis Clinical Site #3

New Hyde Park, New York, United States

Exelixis Site #14

New York, New York, United States

Exelixis Site #13

Shirley, New York, United States

Exelixis Site #15

The Bronx, New York, United States

Exelixis Clinical Site #2

Nashville, Tennessee, United States

Exelixis Clinical Site #16

Salt Lake City, Utah, United States

Exelixis Site #4

Spokane, Washington, United States

Exelixis Site #12

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

XL092-009

Identifier Type: -

Identifier Source: org_study_id