RecruitingPhase 1/2

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

United States265 participantsStarted 2022-09-30

Plain-language 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)

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Must be ≥18 years of age, with documented RET-altered cancers
✓. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
✓. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
✓. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
✓. Additional cohort specific criteria apply

✕. 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 medication
✕. Severe or uncontrolled medical condition or psychiatric condition
✕. Chronic glomerulonephritis or renal transplant
✕. Patients with active hepatitis B infection or active hepatitis C
✕. Patients 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 months
✕. Receipt of any strong inhibitor or inducer of CYP3A4

Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment

Timeframe: First 28 days of treatment

Modules B and C: Overall Response Rate (ORR) as measured using RECIST v1.1

Timeframe: 12 months

NCT IDNCT05443126

SponsorEllipses Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

Clinical Trials Team

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Must be ≥18 years of age, with documented RET-altered cancers
✓. Patients should be well informed and consented about alternative treatment options including approved RET-targeted therapies
✓. ECOG performance status of 0 or 1 and life expectancy \>3 months at screening
✓. Ability to understand and provide written informed consent and able to participate in all required evaluations and procedures
✓. Additional cohort specific criteria apply

✕. 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 medication
✕. Severe or uncontrolled medical condition or psychiatric condition
✕. Chronic glomerulonephritis or renal transplant
✕. Patients with active hepatitis B infection or active hepatitis C
✕. Patients 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 months
✕. Receipt of any strong inhibitor or inducer of CYP3A4