The trial will focus on investigating the tolerability, safety, and therapeutic efficacy of multiple doses of 131I-TM601 when administered intravenously. This study follows the clinical confirmation in a now completed Phase I trial that intravenously (IV)-delivered 131I-TM601 crosses the blood-brain barrier and specifically targets and binds to tumor tissue.
The Phase I/II trial will enroll approximately 64 patients aged 18-years and older who have failed prior radiation treatment, with or without chemotherapy. The study will be conducted at up to 20 clinical sites across the US.
The primary study objectives are to determine the safety, tolerability and efficacy of multiple doses of radiolabeled TM601. The secondary objective is to evaluate, in a subset of patients, the level of radiation absorbed by the target tumor and also by other organs, stemming from intravenous delivery.
Prior to initiating treatment as part of the study, patients will receive an imaging dose of 131I-TM601 to determine which patients demonstrate tumor-specific localization and uptake of the drug. Only those patients who demonstrate tumor uptake of 131I-TM601 will be deemed appropriate to continue in the study and receive higher treatment doses.
The study will be conducted in two phases. In the first phase, patients will be assigned to dosing cohorts and receive two-to-five weekly IV doses of 131I-TM601. Escalation to the next highest dose level will be dependent upon the demonstrated tolerance in the previous dose level. Patients enrolled in the second phase of the study will be assigned to the optimal dose-level determined by the experience in the first phase.
Michael Egan, president and CEO of TransMolecular, said: “With this study, we hope to build upon these previous results and further advance the diverse TM601 platform.”