Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
← catalyst calendarNCT05176483 · readout in 164 d
Sponsored by Exelixis (industry) · EXEL — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,394estimated
Sites
122
Countries
Australia, Austria, Belgium +10
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-12-14 | actual | When the study began enrolling |
| Primary completion | 2027-01-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2030-06-28 | estimated | The whole study's end, after follow-up |
| First posted | 2022-01-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-05 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
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)
- Clear Cell Renal Cell Carcinoma (ccRCC)
- Non-Clear Cell Renal Cell Carcinoma (nccRCC)
- Drug-Drug Interaction (DDI)
Interventions
- Drug: Zanzalintinib — also filed as XL092
- Drug: Nivolumab — also filed as Opdivo
- Drug: Ipilimumab — also filed as Yervoy
- Drug: Nivolumab — also filed as Opdivo
- Drug: Nivolumab — also filed as Opdivo
- Drug: Nivolumab + Relatlimab
- Drug: Prednisone
- Drug: Docetaxel
- Drug: DDI Probe Cocktail
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Including Immune-Mediated Adverse Events (imAEs)
measured Up to 36 months
Expansion Stage (All Cohorts Except Cohort 15 [mCRPC, post-ARPI, visceral metastases] and Cohort 16 [DDI]): Objective Response Rate (ORR)
measured Up to 24 months
Expansion Stage Cohort 3 (mCRPC, post 1 NHT): Progression-Free Survival (PFS)
measured Up to 24 months
Expansion Stage Cohort 10 (CRC): Overall Survival (OS)
measured 6 months
Expansion Stage Cohort 15 (mCRPC, Post-ARPI, Visceral Metastases): PFS-6 (Six Month PFS)
measured 6 months
Expansion Stage Cohort 16 (DDI): Area Under the Concentration-Versus-Time Curve (AUC) of Each DDI Probe Substrate With and Without Zanzalintinib
measured Predose upto 8 hours postdose
Expansion Stage Cohort 16 (DDI): Maximum Concentration (Cmax) of Each DDI Probe Substrate With and Without Zanzalintinib
measured Predose upto 8 hours postdose
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