A Phase 1 of CTX-8371 in Patients With Advanced Malignancies
Trial Parameters
Brief Summary
This is a Phase 1, open-label, first-in-human study of CTX-8371 administered as a monotherapy in patients with metastatic or locally advanced malignancies. The study will be conducted in 2 cohorts: Dose Escalation and 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 1. Malignant Melanoma (MM) * Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 blocking antibody * Patients must have had prior testing for BRAF V600 mutations. Patients with BRAF V600 activating mutation must have received prior therapy with a BRAF/MEK inhibitor * Uveal and mucosal melanoma are excluded 2. Head and Neck squamous cell carcinoma (HNSCC) * HNSCC of oral cavity, oropharynx, hypopharynx, or larynx * Patients who have progressed after a minimum of 2 doses of a PD-1/PD-L1 treatment. Study enrollment (C1D1) must be within 12 weeks of the last dose of the anti-PD-1/PD-L1 b