Zanzalintinib for Metastatic Clear Cell Renal Cell Carcinoma With Bone Metastases

Part of paid clinical trials in San Francisco, California.

Sponsor
Kelly Fitzgerald, MD
Study ID
NCT07043608
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zanzalintinib — DRUG
    Given orally (PO)
  • Investigator Choice of Bone Strengthening Agents (BSA) — DRUG
    One BSA will be chosen, at the discretion of the investigator and given intravenously (IV)
  • Non-Investigational Radiation Therapy (RT) — RADIATION
    Non-investigational RT is permitted for symptomatic bone metastases.
  • Bone Scan — PROCEDURE
    Undergo Bone Scan
  • Computerized tomography (CT) Scan — PROCEDURE
    Undergo Imaging

Study Details

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.

Key Dates

Start date
May 30, 2026
Status verified
Apr 2026
Primary completion
Feb 28, 2029
Completion
Feb 28, 2030

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Zanzalintinib)
    Participants will receive 100 mg Zanzalintinib administered orally once a day in 28-day cycles, starting on cycle 1, day 1, and continued until criteria for removal from study are met. Investigator-choice bone-strengthening agent (BSA) will be selected and administered at a standard dose/interval starting within 30 days of cycle 1, day 1. Non-investigational RT for symptomatic metastases, including bone metastases, is allowed per investigator discretion. Participants must receive at least 1 dose of zanzalintinib prior to treatment pause for RT. Participants may continue study treatment until they are unable to tolerate treatment due to toxicity or demonstrate progression (per RECIST) from the time of initiating treatment.

Primary Outcome Measure

Proportion of participants who have not progressed at 12 months (PFS12) [ Time Frame: Up to 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
UCSF Genitourinary Oncology Clinical Trials Recruitment
[email protected]
877-827-3222
Kelly Fitzgerald, MD (PRINCIPAL_INVESTIGATOR)

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