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
Study Identifier:
EP0031-101
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruiting
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Study Summary
To evaluate the safety, tolerability and efficacy of EP0031 in patients with advanced RET-altered thyroid and non-small cell lung cancer including patients who have not received prior treatment with first generation SRIs.
To evaluate whether EP0031, an orally available next generation SRI, can address resistance to 1st generation SRIs and improve on their clinical profile.
To investigate safety, tolerability, PK and PD and to define the maximum tolerated dose (MTD) and/or Recommended Phase II Dose (RP2D).
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Non-Small Cell Lung Cancer
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase I/II
Sex
Female & Male
Age
18+ years
Study Drug
Drug: Experimental: RET fusion-positive NSCLC (treatment naïve i.e. no prior therapy) in combination w/ SOC chemotherapy
Read More
Drug: AACR 2026:
Study Status
Indicates the current recruitment status or the expanded access status
Recruiting
Requirements information
Inclusion criteria
- Applicable to all participants:
- Must be ≥18 years of age, with documented RET-altered NSCLCParticipants should be well informed and consented about alternative treatment options including approved RET-targeted therapiesECOG performance status of 0 or 1 and life expectancy >3 months at screeningAbility to understand and provide written informed consent and able to participate in all required evaluations and proceduresMeasurable disease defined by RECIST v1.1Must have locally advanced or metastatic NSCLC with RET fusion who are eligible to receive platinum-based doublet chemotherapy.First line patients: Must not have received a Selective RET inhibitor or chemotherapy. Prior adjuvant and neo-adjuvant therapies (chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agents), or definitive radiation/chemoradiation with or without regimens including immunotherapy, biologic therapy, investigational agents, are permitted as long as treatment was completed at least 12 months prior. Palliative radiotherapy for symptom management (eg, bone metastases) is permitted up to 2 weeks prior to treatment start.
Exclusion criteria
- Participants with any of the following will not be included in the study:
- Any known major driver gene alterations other than RET.Spinal cord compression or brain metastases. Patients with stable brain metastases can be enrolled.Active infection requiring systemic antibiotic, antifungal, or antiviral medicationSevere or uncontrolled medical condition or psychiatric conditionChronic glomerulonephritis or renal transplantParticipants with active hepatitis B infection or active hepatitis CParticipants with active HIV infection. Patients living with HIV may be eligible if they have adequate CD4+ T-cell count and no history of AIDS-defining opportunistic infections in the past 12 monthsReceipt of any strong inhibitor or inducer of CYP3A4Impaired hepatic or renal function, inadequate bone marrow reserve or organ functionAny clinically important abnormalities in rhythm, conduction, or morphology on resting ECG or any factor that increases the risk of QTc prolongation or of arrhythmic events , or congestive heart failure Grade III-IV according to the New York Heart Association, myocardial infarction, or unstable angina within the previous 6 monthsUncontrolled hypertensionCorneal ulceration or untreated keratitis at screening
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Irene Moreno
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer