Compass Therapeutics
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.
This Phase 1, open-label, first-in-human study will evaluate the safety, tolerability, immunogenicity, and pharmacokinetics profile of CTX-10726 monotherapy. Preliminary anti-tumor activity of CTX-10726 will also be assessed. The study will be conducted in 2 cohorts: Dose escalation and Dose expansion. The Dose Escalation Cohort will utilize a 3+3 design to evaluate four dose levels (0.3-10.0mg/kg) of CTX-10726 given as an IV infusion once every 2 weeks. Patients in the Dose Expansion Cohort will receive CTX-10726 as an IV infusion at dose(s) based on data from the Dose Escalation Cohort.
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…
Intravenous (IV) infusion (0.3-10.0mg/kg) every two weeks.