Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05176483 · ClinicalTrials.gov registry record · Phase 1
Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
A Phase 1 study of Solid Tumor and Non-small Cell Lung Cancer (NSCLC), sponsored by Exelixis.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 1,314
- Enrollment target
- 20
- Study locations
NCT05176483: Recruiting Phase 1 study of Solid Tumor and Non-small Cell Lung Cancer (NSCLC), sponsored by Exelixis.
NCT05176483 is a Phase 1 study of Solid Tumor and Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Exelixis. The registered enrollment target is 1,314 participants, above the 215-participant average among 196 other Solid Tumor trials with a reported enrollment target (511% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05176483, a Phase 1 study of Solid Tumor and Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Exelixis.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 1,314 participants
- Enrollment target
- 20
- Study locations
Study Summary
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) 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.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Zanzalintinib
Study Locations (20)
Florida
- Exelixis Clinical Site #48 - Celebration
- Exelixis Clinical Site #11 - Gainesville
- Exelixis Clinical Site #78 - Jacksonville
- Exelixis Clinical Site #47 - Miami
- Exelixis Clinical Site #61 - Plantation
- Exelixis Clinical Site #8 - Tampa
Arizona
- Exelixis Clinical Site #67 - Phoenix
- Exelixis Clinical Site #1 - Tucson
California
- Exelixis Clinical Site #123 - Palo Alto
- Exelixis Clinical Site #59 - Santa Barbara
Michigan
- Exelixis Clinical Site #65 - Detroit
- Exelixis Clinical Site #13 - Detroit
Colorado
- Exelixis Clinical Site #87 - Littleton
Connecticut
- Exelixis Clinical Site #62 - New Haven
Delaware
- Exelixis Clinical Site #49 - Newark
Illinois
- Exelixis Clinical Site #26 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,314 participants |
| Start Date | 2021-12-14 |
| Est. Completion | 2030-06-28 |
| Phase | Phase 1 |
What NCT05176483 shows while recruiting
NCT05176483 is an interventional study that assigns participants to a tested intervention. Its 1,314 participants enrollment target places it among the larger protocols in the corpus, above the 215-participant average among 196 other Solid Tumor trials with a reported enrollment target (511% higher).
The record links to 10 conditions, with Solid Tumor appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT05176483 names 20 study sites across 12 states, led by Florida, Arizona, California.
Frequently Asked Questions
What is clinical trial NCT05176483 about?
NCT05176483 is a clinical study titled "Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors". 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 + i...
What is the current status of trial NCT05176483?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 1,314 participants. The study started on 2021-12-14. Estimated completion is 2030-06-28.
What conditions does trial NCT05176483 study?
This clinical trial studies the following conditions: Solid Tumor, Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Hepatocellular Carcinoma (HCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC).
What interventions are being tested in trial NCT05176483?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Zanzalintinib (DRUG).
Who is sponsoring clinical trial NCT05176483?
This trial is sponsored by Exelixis, which has 48 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05176483 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Solid Tumor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05176483's enrollment target sits among peer trials
1,314 4th of 196 higher than 193 of 196 other Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Evaluate Safety, Efficacy, and Pharmacokinetics in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
RECRUITING · Phase 1
-
Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors
RECRUITING · Phase 1
-
Concurrent Azeliragon With Craniospinal Irradiation
RECRUITING · Phase 1
-
Safety and Tolerability of TNG456 Alone and in Combination With Abemaciclib in Patients With Solid Tumors With MTAP Loss
RECRUITING · Phase 1
-
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06136650 · 1,314 participants · Phase 3
A Study of Opevesostat (MK-5684) Versus Alternative Next-generation Hormonal Agent (NHA) in Metastatic Castration-resistant Prostate Cancer (mCRPC) Post One NHA (MK-5684-004)
- NCT05762302 · 1,316 participants · NA
The Impact of MeMed BV® on Management of Patients With Suspected Lower Respiratory Tract Infections (LRTI) in the Emergency Department (ED) and Urgent Care Center (UCC) ("JUPITER" TRIAL)
- NCT06556433 · 1,312 participants · NA
Family-Based Financial Incentives Intervention for Smoking Cessation
- NCT06136624 · 1,310 participants · Phase 3
Study of Opevesostat (MK-5684) Versus Alternative NHA in mCRPC (MK-5684-003)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI