Study of Zanzalintinib in Combination With Immuno-Oncology 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) 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)

Interventions

DRUG

Zanzalintinib

Zanzalintinib orally once daily (qd)

DRUG

Nivolumab

360 mg 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

Sponsors & Collaborators

• Exelixis

  lead INDUSTRY

Principal Investigators

• Medical Director · Exelixis

Study Design

Allocation

NON_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

2030-06-28

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