ClinicaliQ Trial Snapshot
- Study of Zanzalintinib in Combination With Immuno-Oncology Agents in Participants With Solid Tumors — Recruiting • Phase I • Oncology • NCT05176483.
- What is being tested: Zanzalintinib (a novel therapeutic agent) is being evaluated as monotherapy and in combination with immune checkpoint inhibitors (nivolumab ± ipilimumab) in a Phase 1b dose-escalation study to assess safety, tolerability, pharmacokinetics, and antitumor activity in solid tumors.
- Patient eligibility overview: This multicenter trial enrolls patients with advanced solid tumors; specific eligibility criteria typically include confirmed malignancy, adequate organ function, and prior treatment history varying by cohort, though full inclusion/exclusion criteria would be detailed in the complete protocol.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
Eligibility Snapshot
- Key Inclusion Criteria: * Cytologically or histologically confirmed solid tumor that is unresectable, locally advanced or metastatic. * Dose-Escalation Cohorts: Participants with a solid tumor that is unresectable or metastatic and for which life-prolonging therapies do not exist or available therapies are intolerable or no longer effective. * Expansion Cohort 1 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component who have not received prior systemic therapy. * Note: Prior non-vascular endothelial growth factor (VEGF) targeted adjuvant or neoadjuvant is allowed if disease recurrence occurred 6 months after the last dose. * Expansion Cohort 2 (ccRCC): Participants with unresectable advanced or metastatic RCC with a clear cell component. * Must have radiographically progressed after a combination therapy consisting of a Programmed Cell Death Protein 1 (PD-1)/Programmed death-ligand 1 (PD-L1) targeting monoclonal antibody (mAb) with a Vascular endothelial growth factor (receptor) tyrosine kinase inhibitor (VEGFR-TKI) or a PD-1 targeting mAb with a CTLA-4 mAb as the preceding line of therapy. * Must have received no more than one prior systemic anticancer therapy for unresectable advanced or metastatic renal cell carcinoma. * Expansion Cohort 3 (mCRPC): Men with metastatic adenocarcinoma of the prostate. * Must have progressed during…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.