A Phase I Study of TK-6302 in Patients with Advanced PRAME-Positive Solid Tumors Harboring the HLA-A*02:01 Allele

The primary objective of this study is to evaluate the efficacy of TK-6302 in patients presenting with advanced PRAME-positive solid tumors expressing the HLA-A02:01 genetic marker. Assessing this therapeutic agent is clinically relevant for determining its potential to target specific tumor antigens in a precision medicine framework. 5

The sponsor did not provide information regarding the total number of participants. The study population consists of patients diagnosed with advanced PRAME positive solid tumors. The cohort includes both male and female individuals within the age range of 5 to 17 years.

This Phase 1 clinical trial is designed to evaluate the safety and preliminary efficacy of TK-6302 in individuals diagnosed with advanced PRAME-positive solid tumors. The study population is restricted to patients exhibiting the HLA-A02:01 genetic marker. The research methodology involves a series of scheduled clinical assessments beginning with a screening visit to determine eligibility based on predefined inclusion criteria. Following successful screening, participants will undergo treatment administration and subsequent follow-up visits to monitor physiological responses and potential adverse events. The sequence of procedures concludes with an end-of-study visit. Total participation duration is determined by individual clinical progress and safety monitoring requirements. Early termination of study involvement may occur due to disease progression, the occurrence of unacceptable toxicity, or the decision of the investigator to ensure participant safety.

Efficacy assessment in this phase 1 clinical trial focuses on patients with advanced PRAME positive solid tumors. The evaluation of therapeutic response and clinical outcomes will be conducted according to established protocols.