NCT05443126

A Study of EP0031 in Patients With Advanced RET-altered Malignancies

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 265 (estimated)
• Sponsor: Ellipses Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the safety, side effects and effectiveness of EP0031 in patients with advanced RET-altered malignancies (NSCLC)

Detailed description

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.

Conditions

• Advanced Solid Tumor
• NSCLC

Interventions

Type	Name	Description
DRUG	EP0031	EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Timeline

• Start date: 2022-09-30
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2022-07-05
• Last updated: 2026-02-03

Locations

40 sites across 7 countries: United States, France, Germany, Italy, Spain, United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study