NCT05176483PHASE1RECRUITING

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

A Dose-Escalation and Expansion Study of the Safety and Efficacy of XL092 in Combination With Immuno-Oncology Agents in Subjects With Unresectable Advanced or Metastatic Solid Tumors

Sponsor: Exelixis

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

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Key Facts

Study type

INTERVENTIONAL

Conditions

Renal Cell Carcinoma (RCC), Metastatic Castration-Resistant Prostate Cancer (mCRPC), Urothelial Carcinoma (UC), Solid Tumor, Hepatocellular Carcinoma (HCC)

Interventions

Zanzalintinib, Nivolumab, Ipilimumab, Nivolumab

Enrollment

1,314 participants

Primary completion

Jun 2030

Study completion

Jun 2030

First posted

Jan 2022

Last updated

May 2026

Primary Endpoints (CT.gov)

Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), Including Immune-Mediated Adverse Events (imAEs)

Time frame: Up to 36 months

Expansion Stage: Objective Response Rate (ORR)

Time frame: Up to 24 months

Expansion Stage Cohort 3 (mCRPC): Progression-Free Survival (PFS)

Time frame: Up to 24 months

Expansion Stage Cohort 10 (CRC): Overall Survival (OS)

Time frame: 6 months

Secondary Endpoints

Expansion Stage: Duration of Response (DOR)

Expansion Stage: Progression-Free Survival (PFS)

Eligibility Criteria

Key Inclusion Criteria: * Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic. * Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. * Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy. * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose. * Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component. * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)/Programmed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascu…

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov