A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
858 Therapeutics, Inc.
Study ID
NCT06395519
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • ETX-19477 — DRUG
    Oral medication taken daily

Study Details

This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.

Key Dates

Start date
May 13, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 Part 1: Monotherapy Dose Escalation
    Participants will be assigned to a dose level.
  • Experimental: Phase 1 Part 2: Monotherapy Dose Expansion
    After a dose is decided in Part 1, participants entering part 2 will be assigned to a dose level.

Primary Outcome Measure

To characterize the safety and tolerability of ETX-19477, the maximum tolerated dose (MTD) and/or RP2D of ETX-19477 [ Time Frame: 6 months ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Felipe Batalini, MD (PRINCIPAL_INVESTIGATOR)
Yale University, Yale Cancer CenterNew HavenConnecticut06510
Michael Cecchini, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
Pooja Advani, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medical CenterChicagoIllinois60637
Han Cun, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Richard T Penson, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Siddhartha Yadav, MD (PRINCIPAL_INVESTIGATOR)
Laura & Isaac Perlmutter Cancer Center at NYU Langone HealthNew YorkNew York10016
Nancy Chan, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Ezra Y Rosen, MD, PhD (PRINCIPAL_INVESTIGATOR)
Stefanie Spielman Comprehensive Breast CenterColumbusOhio43212
Sagar Sardesai, MBBS (PRINCIPAL_INVESTIGATOR)
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer CenterPhiladelphiaPennsylvania19107
Kevin Zarrabi, MD (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Timothy A Yap, MD, PhD (PRINCIPAL_INVESTIGATOR)
START Center for Cancer Care - Mountain RegionSalt Lake CityUtah84112
William B. McKean, Jr, MD (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander I Spira, MD (PRINCIPAL_INVESTIGATOR)
Fred Hutchinson Cancer CenterSeattleWashington98109
Kalyan Banda, MD (PRINCIPAL_INVESTIGATOR)

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