Status:
TERMINATED
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)
Lead Sponsor:
Exelixis
Collaborating Sponsors:
Arcus Biosciences, Inc.
Conditions:
Advanced Clear Cell Renal Cell Carcinoma or Other Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 (tripl...
Eligibility Criteria
Inclusion
- Key
- 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.
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
January 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2025
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06191796
Start Date
January 25 2024
End Date
May 12 2025
Last Update
June 12 2025
Active Locations (14)
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1
Exelixis Site #8
Los Angeles, California, United States, 90033
2
Exelixis Site #9
Miami, Florida, United States, 33176
3
Exelixis Clinical Site #1
Orlando, Florida, United States, 32804
4
Exelixis Site #11
Tampa, Florida, United States, 33612