Zanzalintinib and MO-03 for the Treatment of Metastatic Renal Cell Cancer After Progression on Immunotherapy

Part of paid clinical trials in Duarte, California.

Sponsor
City of Hope Medical Center
Study ID
NCT07578025
Phase
PHASE2
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Metastatic Clear Cell Renal Cell Carcinoma
  • Stage IV Renal Cell Cancer AJCC v8

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood and urine sample collection
  • Bone Scan — PROCEDURE
    Undergo bone scan
  • C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03 — DRUG
    Given PO
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Zanzalintinib — DRUG
    Given PO

Study Details

This phase II trial tests how well zanzalintinib and MO-03 works for the treatment of renal cell cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and that is growing, spreading, or getting worse (progression) after receiving immunotherapy. Zanzalintinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. MO-03 is a type of medication called a microbiome-based immunomodulator. It helps control some of the bacteria found in the gut which may make the zanzalintinib more effective. Giving zanzalintinib with MO-03 may be effective for treating metastatic renal cell cancer after progression on immunotherapy.

Key Dates

Start date
Nov 28, 2026
Status verified
May 2026
Primary completion
Jun 24, 2028
Completion
Jun 24, 2028

Study Design

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

Arms

  • Experimental: Treatment (zanzalintinib and MO-03)
    Patients receive XL092 PO QD and MO-03 PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Study treatment may continue after progression if the Investigator believes that the subject is still receiving clinical benefit. Patients undergo CT scan, bone scan, and blood and urine sample collection throughout the study.

Primary Outcome Measure

Overall response rate [ Time Frame: Up to 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
City of Hope Medical CenterDuarteCalifornia91010
Sumanta K. Pal
[email protected]
626-256-4673
Sumanta K. Pal (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Medical Center· Duarte, CA

Related Studies