A Phase 1 Study of the Safety and Tolerability of CTX-10726
Trial Parameters
Eligibility Fast-Check
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Brief Summary
This is a Phase 1, open-label, first-in-human study of CTX-10726 monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 Cohorts: Cohort 1 Dose Escalation and Cohort 2 Dose Expansion.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 years or older. 2. Patients must have a histologically or cytologically confirmed diagnosis of locally advanced unresectable or metastatic disease that is relapsed/refractory to standard therapy or for which no effective standard therapy is available, including: 2a: Renal Cell Carcinoma (RCC) * Histologically confirmed diagnosis of renal cell carcinoma (with clear cell component) with advanced or metastatic disease that is not amenable to cure by surgery or other means. * Patients who have progressed after a minimum of 2 doses of a programmed cell death 1 (PD-1)/ programmed cell death ligand 1 (PDL1) treatment. * Patients must have received at least one regimen including a tyrosine kinase inhibitor (TKI). * Patients who received immunomodulatory drugs (thymosin, interferon, interleukin, etc.) within 2 weeks before the first dose or received major surgical treatment within 3 weeks before the first dose are not eligible. 2b: Hepatocellular Carcinoma (HCC) *