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.
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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
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