Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

Part of paid clinical trials in Duarte, California.

Sponsor
ORIC Pharmaceuticals
Study ID
NCT05315700
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • ORIC-114 — DRUG
    ORIC-114 oral daily
  • Chemotherapy drug — DRUG
    21 days for up to 4 cycles

Study Details

The purpose of this study is to establish the recommended Phase 2 dose (RP2D) and/or maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of ORIC-114 as a Single Agent or in Combination with Chemotherapy when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration.

Key Dates

Start date
Mar 10, 2022
Status verified
Jul 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

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

Arms

  • Experimental: Dose Escalation and Dose Optimization
    ORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles.
  • Experimental: Combination Dose Escalation
    ORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: 12 months ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
City of HopeHuntington BeachCalifornia90813-
City of HopeIrvineCalifornia92618-
City of HopeLong BeachCalifornia90813-
University of California, San FranciscoSan FranciscoCalifornia94122-
Yale Cancer CenterNew HavenConnecticut06510-
Georgetown UniversityWashington D.C.District of Columbia20007-
Mayo ClinicJacksonvilleFlorida32224-
Moffitt Cancer CenterTampaFlorida33612-
Northwestern UniversityChicagoIllinois60611-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Mayo ClinicRochesterMinnesota55905-
NYU Langone Health Perlmutter Cancer CenterNew YorkNew York10016-
Duke Cancer InstituteDurhamNorth Carolina27710-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Spartanburg Regional Healthcare SystemSpartanburgSouth Carolina29303-
Next OncologyFairfaxVirginia22031-

Find similar trials in Duarte, CA

By research site
City of Hope· Duarte, CACity of Hope· Huntington Beach, CACity of Hope· Irvine, CACity of Hope· Long Beach, CAUniversity of California, San Francisco· San Francisco, CAYale Cancer Center· New Haven, CT

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