TerminatedPhase 1

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)

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

United States25 participantsStarted 2024-01-25

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

What they're measuring

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

Timeframe: Up to 24 months

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

Timeframe: Up to 24 months

Trial details

NCT IDNCT06191796

SponsorExelixis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-12

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