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
City of Hope Medical Center
Summary
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the anti-tumor efficacy of zanzalintinib (XL092) in combination with C. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03 (MO-03) in patients with metastatic renal cell carcinoma (mRCC) at second line or third line after disease progression to both a checkpoint inhibitor and cabozantinib, as measured by the objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 criteria. SECONDARY OBJECTIVES: I. To assess changes in the gut microbiome composition from baseline to week 12, to understand the impact…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 fo…
Interventions
- ProcedureBiospecimen Collection
Undergo blood and urine sample collection
- ProcedureBone Scan
Undergo bone scan
- DrugC. butyricum CBM 588 Probiotic Strain Capsule Formulation MO-03
Given PO
- ProcedureComputed Tomography
Undergo CT scan
- DrugZanzalintinib
Given PO
Location
- City of Hope Medical CenterDuarte, California