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

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) 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.

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

Zanzalintinib orally once daily (qd)

DRUG

Nivolumab

360 mg intravenous (IV) infusion once every 3 weeks (q3w)

DRUG

Ipilimumab

1 mg/kg IV infusion once every 3 weeks (q3w) for maximum of four doses

DRUG

Nivolumab

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)

DRUG

Nivolumab

480 mg IV infusion once every 4 weeks (q4w)

DRUG

Nivolumab + Relatlimab

IV administration of nivolumab + relatlimab

DRUG

Prednisone

Administered as IV infusion.

DRUG

Docetaxel

Administered as oral tablet.

DRUG

DDI Probe Cocktail

Midazolam, Warfarin, Omeprazole, and Caffeine administered orally.

Sponsors & Collaborators

• Exelixis

  lead INDUSTRY

Principal Investigators

• Medical Director · Exelixis

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-12-14

Primary Completion

2027-01-31

Completion

2030-06-28

FDA Drug

Yes

Countries

• United States
• Australia
• Austria
• Belgium
• France
• Germany
• Israel
• Italy
• New Zealand
• Poland
• Spain
• Switzerland
• United Kingdom

Study Locations