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
Ellipses Pharma
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)
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 sel…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Applicable to all patients: 1. Must be ≥18 years of age, with documented RET-altered cancers 2. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies 3. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening 4. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures 5. Additional cohort specific criteria apply Exclusion Criteria: Patients with any of the following will not be included in the study: 1. Any kn…
Interventions
- DrugEP0031
EP0031 is a potent next-generation selective RET-inhibitor (SRI)
Locations (40)
- David Geffen School of Medicine at UCLALos Angeles, California
- Stanford UniversityStanford, California
- Georgetown UniversityWashington D.C., District of Columbia
- Florida Cancer SpecialistFort Myers, Florida
- RUSH University Medical CenterChicago, Illinois
- Northwestern UniversityEvanston, Illinois