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NCT05176483 · ClinicalTrials.gov record · last posted 2026-08-05

Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors

Study acronym: STELLAR-002
StatusRecruiting
PhasePhase 1
SponsorExelixis
Started2021-12-14
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from the ClinicalTrials.gov record
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.

Protocol amendment history 3 changes detected by DataLookout

2026-08-06
Primary endpoint(s) modified
WasExpansion Stage Cohort 10 (CRC): Overall Survival (OS), Expansion Stage Cohort 3 (mCRPC): Progression-Free Survival (PFS), Expansion Stage: Objective Response Rate (ORR), Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Including Immune-Mediated Adverse Events (imAEs)
NowExpansion Stage (All Cohorts Except Cohort 15 [mCRPC, post-ARPI, visceral metastases] and Cohort 16 [DDI]): Objective Response Rate (ORR), Expansion Stage Cohort 10 (CRC): Overall Survival (OS), Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): PFS-6 (Six Month PFS), Expansion Stage Cohort 16 (DDI): Area Under the Concentration-Versus-Time Curve (AUC) of Each DDI Probe Substrate With and Without Zanzalintinib, Expansion Stage Cohort 16 (DDI): Maximum Concentration (Cmax) of Each DDI Probe Substrate With and Without Zanzalintinib, Expansion Stage Cohort 3 (mCRPC, post 1 NHT): Progression-Free Survival (PFS), Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Including Immune-Mediated Adverse Events (imAEs)
2026-08-06
Trial arms changed: 7 → 9
2026-08-06
Primary completion moved earlier: 2030-06-28 → 2027-01-31
Trial Details
NCT Number NCT05176483
Lead Sponsor Exelixis
Conditions Renal Cell Carcinoma (RCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Urothelial Carcinoma (UC), Solid Tumor, Hepatocellular Carcinoma (HCC), Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Head and Neck Squamous Cell Carcinoma (HNSCC) +3 more
Enrollment 1,394 participants
Start Date 2021-12-14
Primary Completion 2027-01-31 (estimated)
Study Completion 2030-06-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-05