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Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases

NCT07043608 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-01

No results posted yet for this study

Summary

This is a single-institution, phase 2 trial of zanzalintinib plus investigator-choice bone-strengthening agent in patients with metastatic renal cell carcinoma (RCC) with bone metastases whose disease has advanced on 1-3 prior lines of therapy, including at least one immune oncology-based (IO) therapy in the adjuvant or first-line metastatic setting.

Conditions

  • Clear Cell Renal Cell Cancer (ccRCC)
  • Clear Cell Renal Carcinoma
  • Clear Cell Renal Cell Carcinoma Metastatic
  • Clear Cell Renal Cancer
  • Bone Metastases of a Malignant Tumor
  • Clear Cell Renal Cell Carcinoma
  • Bone, Metastatic Cancer
  • Metastatic Cancer
  • Metastatic Renal Cell Carcinoma
  • Metastases to Bone

Interventions

DRUG

Zanzalintinib

Given orally (PO)

DRUG

Investigator Choice of Bone Strengthening Agents (BSA)

One BSA will be chosen, at the discretion of the investigator and given intravenously (IV)

RADIATION

Non-Investigational Radiation Therapy (RT)

Non-investigational RT is permitted for symptomatic bone metastases.

PROCEDURE

Bone Scan

Undergo Bone Scan

PROCEDURE

Computerized tomography (CT) Scan

Undergo Imaging

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • Kelly Fitzgerald, MD

    lead OTHER

Principal Investigators

  • Kelly Fitzgerald, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-30
Primary Completion
2029-02-28
Completion
2030-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07043608 on ClinicalTrials.gov