A Modular Open-label Phase I/II Study to Evaluate the Safety Tolerability Pharmacokinetics and Efficacy of EP0031 in Patients with Advanced RET-altered Malignancies

Brief description of study

RET alterations mostly happen in lung cancer and thyroid cancer, these alterations can be picked up on molecular testing and can be a target for a special kind of treatment. This study consists of three modules: A, B and C. The study aims to find the right dose of EP0031 and evaluate its effectiveness in patients with different types of altered tumors. In Module A, we will focus on testing the drug EP0031 on its own to find the right dose for patients with specific RET-altered solid tumors. We will gradually increase the dosage of EP0031 while assessing side effects, how the body processes the drug, and the drug's effect on the tumors. We will also include a subgroup of patients for paired biopsies (the collection of two different tissue samples from the same patient). Once we determine the maximum tolerated dose, we will recruit more patients to determine the optimal dosage for Modules B and C.

Module B involves expanding the study to more patients to better understand the safety, tolerability, and preliminary effectiveness of EP0031. We will include specific tumor types, such as non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC), in patients who have either progressed after first-generation selective RET inhibitor therapy or have not received such therapy.

Module C is a continuation of Module B, focusing on further dose expansion (more patients are enrolled to receive a specific dose of a drug that has been determined to be safe) and effectiveness assessment in patients who have progressed after first-generation selective RET inhibitor therapy. We will assess the effectiveness of EP0031 in specific tumor types and potentially expand the study to include more patients based on successful data from earlier modules. Throughout the study, we will closely monitor safety and involve a Safety Monitoring Committee to guide our decisions on dosing and any necessary adjustments.

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