← Back to results
NCT07578025PHASE2NOT_YET_RECRUITING

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

Phase 2, Single-Arm Trial of Zanzalintinib (XL092) With MO-03 (CBM588 Capsule) in Patients With Metastatic Renal Cell Carcinoma (mRCC) After Progression to Immunotherapy

Sponsor: City of Hope Medical Center + National Cancer Institute (NCI)

No open prediction endpoints

Endpoints are classified and published by ProgramSignal analysts.

Request endpoint coverage

Key Facts

Study type
INTERVENTIONAL
Conditions
Metastatic Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8
Interventions
Biospecimen Collection, Bone Scan, C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03, Computed Tomography
Enrollment
34 participants
Primary completion
Jun 2028
Study completion
Jun 2028
First posted
May 2026
Last updated
May 2026

Primary Endpoints (CT.gov)

Overall response rate

Time frame: Up to 2 years

Secondary Endpoints

Change in gut microbiota composition in stool

Microbial diversity

Proportion of circulating regulatory T cells

Eligibility Criteria

Inclusion Criteria: * Capable of understanding and complying with the protocol requirements and must have signed the informed consent document * Agreement to allow the use of archival tissue from diagnostic tumor biopsies * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: ≥ 18 years * Gender: Males and females are eligible * Any ethnicity or race * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed renal cell carcinoma with a clear-cell histology * Patients must have received one or two prior lines of systemic therapy for metastatic disease, which must include prior treatment with a checkpoint inhibitor and cabozantinib (not necessarily in the same line). Prior use of hypoxia-inducible factor (HIF) inhibitors or other tyrosine kinase inhibitors (TKIs) other than cabozantinib are not allowed * Measurable metastatic disease by RECIST v 1.1 criteria * Recovery to baseline or ≤ grade 1 severity (CTCAE v 6.0) from adv

Read full criteria on CT.gov →

✦ Analyst Commentary

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

Request coverage →

Source

Open on ClinicalTrials.gov