TR64 in Patients With Advanced Solid Tumors
This study tests a new drug called TR64 in patients with advanced solid tumors that have not responded to standard treatments. Researchers will gradually increase the dose to find the safest and most effective level, while carefully monitoring for side effects.
Key Objective: The trial aims to determine if TR64 can be safely used to treat advanced solid tumors and establish the optimal dose for future studies.
Who to Consider: Patients with advanced solid tumors who have limited treatment options or have not benefited from standard therapies should consider enrolling.
Trial Parameters
Brief Summary
This is a open-label, dose escalation, accelerated titration combined 3+3 design, phase I study, to evaluate the safety and tolerability, and to determine the RP2D of TR64 when administered qd in patients with advanced solid tumors. Up to 6 cohorts of 1-6 or 3-6 patients each will be treated in the study.
Eligibility Criteria
Inclusion Criteria: * Fully understand the procedures of the clinical study and participate voluntarily with signed and dated written informed consent form, comply with the requirements of the study protocol. * Males and/or females at least 18 years old when signing the informed consent form. * Histologically or cytologically confirmed patients with advanced malignant solid tumors, eligible patients must have failed standard treatment, no standard treatment, or not suitable for standard treatment at this stage as determined by the investigator. * Measurable disease with at least one lesion amenable to response assessment per RECIST 1.1. * Eastern cooperative oncology group performance status (ECOG) ≤2 at screening. * Life expectancy of at least 3 months. * Acceptable organ function: Absolute neutrophil count(ANC)≥1.5×109/L; Platelet count(PLT)≥90×109/L; Hemoglobin(Hb)≥90 g/L; Total bilirubin(TBIL)≤1.5×Upper limit of normal value(ULN); Alanine aminotransferase(ALT)≤2.5×ULN; Aspartate am