The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies (NSCLC)
EP0031 is being investigated in this modular, interventional Phase I/II dose escalation and dose expansion study to investigate the optimal dose in adult patients with advanced RET-altered malignancies. Currently there are no approved RET-targeted treatments for patients who progress on first-generation SRIs. However, it is proposed that EP0031 can overcome resistance mechanisms to first generation SRIs, as EP0031 is a potent and selective RET inhibitor with broad activity against common RET fusions and mutations. Phase I (dose escalation and optimization) has completed and a RP2D has been selected for Phase II.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
265
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment
Time frame: First 28 days of treatment
Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1
Time frame: 12 months
Area under the plasma concentration versus time curve (AUC)
To characterise the pharmacokinetics (PK) of EP0031
Time frame: First 48 hours after drug administered
Maximum Plasma Concentration (Cmax)
To characterise the pharmacokinetics (PK) of EP0031
Time frame: First 24 hours after drug administered
Time taken for drug concentration to fall from half its original value (Half-life)
To characterise the pharmacokinetics (PK) of EP0031
Time frame: First 72 hours after drug administered
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