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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Ellipses Pharma
Study ID
NCT05443126
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumor
  • NSCLC

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EP0031 — DRUG
    EP0031 is a potent next-generation selective RET-inhibitor (SRI)

Study Details

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

Key Dates

Start date
Sep 30, 2022
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
265 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RET fusion-positive NSCLC (prior 1st gen SRI)
    EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
  • Experimental: RET mutation-positive MTC (prior 1st gen SRI)
    EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
  • Experimental: Other RET-altered solid tumours (prior 1st gen SRI)
    EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
  • Experimental: RET fusion-positive NSCLC (no prior SRI therapy)
    EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
  • Experimental: RET mutation-positive MTC (no prior SRI therapy)
    EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal
  • Experimental: Other RET-altered solid tumours (no prior SRI therapy)
    EP0031 capsules at the recommended phII dose, taken once daily until progressive disease (PD), unacceptable toxicity or patient withdrawal

Primary Outcome Measure

Module A: Incidence of Dose-limiting Toxicity (DLTs ) during the first 28 days of EP0031 treatment [ Time Frame: First 28 days of treatment ]

Central Contacts

Locations (18)

FacilityCityStateZIPSite coordinators
David Geffen School of Medicine at UCLALos AngelesCalifornia90095
Andrew Gianoukakis, MD
[email protected]
Stanford UniversityStanfordCalifornia94305
Emmanuel Ugwu
[email protected]
Saad Khan (PRINCIPAL_INVESTIGATOR)
Georgetown UniversityWashington D.C.District of Columbia20057
Stephen Liu, MD
[email protected]
Florida Cancer SpecialistFort MyersFlorida33908
Judy Wang, MD
[email protected]
RUSH University Medical CenterChicagoIllinois60612-
Northwestern UniversityEvanstonIllinois60208
University of KentuckyLexingtonKentucky40506
Susanne Arnold
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Lori Wirth, MD
[email protected]
KarmanosDetroitMichigan48201-
Memorial Sloan Kettering Cancer CenterNew YorkNew York07920
Alex Drilon, MD
[email protected]
NYU Langone HealthNew YorkNew York10016
Salman Punekar, MD
[email protected]
Providence Portland Medical CentrePortlandOregon97213
Matthew H Taylor, MD
[email protected]
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Marcia Brose, M.D
[email protected]
Sarah CannonNashvilleTennessee37203
Nurse Navigator Hotline
(844) 482-4812
David Spiegel, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Yasir Elamin, MD
[email protected]
Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira, MD
[email protected]
Seattle Cancer Care / Fred Hutchinson Cancer Research CenterSeattleWashington98109
Rebecca Wood
[email protected]
206-606-6970
Christina Baik, MD (PRINCIPAL_INVESTIGATOR)
Washington UniversitySeattleWashington63130
Daniel Morgensztern, MD
[email protected]

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