Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors
Public ClinicalTrials.gov record NCT05176483. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology or Other Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05176483
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 1,394 participants
Conditions and interventions
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
- Zanzalintinib Drug
- Nivolumab Drug
- Ipilimumab Drug
- Nivolumab + Relatlimab Drug
- Prednisone Drug
- Docetaxel Drug
- DDI Probe Cocktail Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2021
- Primary completion
- Jan 30, 2027
- Completion
- Jun 27, 2030
- Last update posted
- Aug 4, 2026
2021 – 2030
United States locations
- U.S. sites
- 46
- U.S. states
- 26
- U.S. cities
- 41
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Exelixis Clinical Site #67 | Phoenix | Arizona | 85054 | Recruiting |
| Exelixis Clinical Site #1 | Tucson | Arizona | 85711 | Recruiting |
| Exelixis Clinical Site #123 | Palo Alto | California | 94304 | Recruiting |
| Exelixis Clinical Site #59 | Santa Barbara | California | 93463 | Recruiting |
| Exelixis Clinical Site #87 | Littleton | Colorado | 80124 | Recruiting |
| Exelixis Clinical Site #62 | New Haven | Connecticut | 06510 | Recruiting |
| Exelixis Clinical Site #49 | Newark | Delaware | 19713 | Active, not recruiting |
| Exelixis Clinical Site #48 | Celebration | Florida | 34747 | Recruiting |
| Exelixis Clinical Site #11 | Gainesville | Florida | 32610 | Recruiting |
| Exelixis Clinical Site #78 | Jacksonville | Florida | 32224 | Recruiting |
| Exelixis Clinical Site #47 | Miami | Florida | 33136 | Recruiting |
| Exelixis Clinical Site #61 | Plantation | Florida | 33322 | Recruiting |
| Exelixis Clinical Site #8 | Tampa | Florida | 33612 | Recruiting |
| Exelixis Clinical Site #26 | Chicago | Illinois | 60612 | Recruiting |
| Exelixis Clinical Site #4 | Indianapolis | Indiana | 46250 | Recruiting |
| Exelixis Clinical Site #122 | Louisville | Kentucky | 40202 | Recruiting |
| Exelixis Clinical Site #14 | Baltimore | Maryland | 21201 | Recruiting |
| Exelixis Clinical Site #7 | Boston | Massachusetts | 02215 | Recruiting |
| Exelixis Clinical Site #65 | Detroit | Michigan | 48201 | Recruiting |
| Exelixis Clinical Site #13 | Detroit | Michigan | 48202 | Recruiting |
| Exelixis Clinical Site #68 | Rochester | Minnesota | 55905 | Recruiting |
| Exelixis Clinical Site #2 | Omaha | Nebraska | 68130 | Recruiting |
| Exelixis Clinical Site #5 | Omaha | Nebraska | 68130 | Active, not recruiting |
| Exelixis Clinical Site #55 | Las Vegas | Nevada | 89052 | Recruiting |
| Exelixis Clinical Site #88 | East Brunswick | New Jersey | 08816 | Recruiting |
| Exelixis Clinical Site #105 | Hackensack | New Jersey | 07601 | Recruiting |
| Exelixis Clinical Site #60 | New York | New York | 10032 | Recruiting |
| Exelixis Clinical Site #6 | New York | New York | 10065 | Recruiting |
| Exelixis Clinical Site #76 | Syracuse | New York | 13210 | Recruiting |
| Exelixis Clinical Site #12 | Durham | North Carolina | 27710 | Recruiting |
| Exelixis Clinical Site #10 | Cleveland | Ohio | 44106 | Recruiting |
| Exelixis Clinical Site #51 | Portland | Oregon | 97239 | Recruiting |
| Exelixis Clinical Site #104 | Hershey | Pennsylvania | 17033 | Recruiting |
| Exelixis Clinical Site #98 | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Exelixis Clinical Site #32 | Pittsburgh | Pennsylvania | 15212 | Recruiting |
| Exelixis Clinical Site #24 | Pittsburgh | Pennsylvania | 15232 | Recruiting |
| Exelixis Clinical Site #9 | Myrtle Beach | South Carolina | 29572 | Recruiting |
| Exelixis Clinical Site #3 | Nashville | Tennessee | 37203 | Recruiting |
| Exelixis Clinical Site #46 | Austin | Texas | 78705 | Recruiting |
| Exelixis Clinical Site #111 | Dallas | Texas | 75246 | Recruiting |
| Exelixis Clinical Site #89 | Dallas | Texas | 75246 | Recruiting |
| Exelixis Clinical Site #73 | Irving | Texas | 75063 | Recruiting |
| Exelixis Clinical Site #50 | Plano | Texas | 75075 | Recruiting |
| Exelixis Clinical Site #70 | Tyler | Texas | 75601 | Recruiting |
| Exelixis Clinical Site #66 | Charlottesville | Virginia | 22903 | Recruiting |
| Exelixis Clinical Site #33 | Milwaukee | Wisconsin | 53226 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 76 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05176483, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 4, 2026 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05176483 live on ClinicalTrials.gov.