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Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494)
druginfo@exelixis.com


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Be Part of Research - Trial Details - Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors
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Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors

Recruiting

Open to: ALL

Age: 18.0 - N/A

Middlesex Cambridge London

Medical 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)

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Dec 2021 Jun 2030

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Zanzalintinib orally once daily (qd)

Intervention Arm Group : Zanzalintinib + Nivolumab + Ipilimumab Dose-Escalation Cohorts;Zanzalintinib + Nivolumab + Ipilimumab Expansion Cohorts;Zanzalintinib + Nivolumab + Relatlimab Dose-Escalation Cohorts;Zanzalintinib + Nivolumab + Relatlimab Expansion Cohorts;Zanzalintinib + Nivolumab Dose-Escalation Cohorts;Zanzalintinib + Nivolumab Expansion Cohorts;Zanzalintinib Single-Agent Expansion Cohorts;

Intervention Type : DRUG
Intervention Description : 360 mg IV infusion once every 3 weeks (q3w)

Intervention Arm Group : Zanzalintinib + Nivolumab Dose-Escalation Cohorts;

Intervention Type : DRUG
Intervention Description : 1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses

Intervention Arm Group : Zanzalintinib + Nivolumab + Ipilimumab Dose-Escalation Cohorts;Zanzalintinib + Nivolumab + Ipilimumab Expansion Cohorts;

Intervention Type : DRUG
Intervention Description : 3 mg/kg IV infusion once every 3 weeks (q3w) for first four doses, and then 480 mg IV infusion once every 4 weeks (q4w)

Intervention Arm Group : Zanzalintinib + Nivolumab + Ipilimumab Dose-Escalation Cohorts;Zanzalintinib + Nivolumab + Ipilimumab Expansion Cohorts;

Intervention Type : DRUG
Intervention Description : 480 mg IV infusion once every 4 weeks (q4w)

Intervention Arm Group : Zanzalintinib + Nivolumab Expansion Cohorts;

Intervention Type : DRUG
Intervention Description : IV administration of nivolumab + relatlimab

Intervention Arm Group : Zanzalintinib + Nivolumab + Relatlimab Dose-Escalation Cohorts;Zanzalintinib + Nivolumab + Relatlimab Expansion Cohorts;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Exelixis Clinical Site #97
    Middlesex
    HA6 2RN
  • Exelixis Clinical Site #110
    Cambridge
    CB2 0QQ
  • Exelixis Clinical Site #99
    London
    W6 8RF

Backup or International 650-837-7400


Exelixis Clinical Trials 1-888-EXELIXIS (888-393-5494)
druginfo@exelixis.com



The study is sponsored by Exelixis



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Read full details for Trial ID: NCT05176483
Last updated 10 February 2026

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