RecruitingPhase 1Phase 2NCT05315700

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

An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

Sponsor

ORIC Pharmaceuticals

Enrollment

350 participants

Start Date

Mar 10, 2022

Study Type

INTERVENTIONAL

Conditions

Solid Tumors

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests ORIC-114, a new targeted therapy, in patients with advanced solid tumors that have specific genetic changes in the EGFR or HER2 genes. These gene changes can drive cancer growth and are found in lung cancer, breast cancer, and other solid tumor types. **You may be eligible if...** - You have advanced (locally advanced or metastatic) solid tumor cancer confirmed by biopsy - Your tumor has a documented EGFR or HER2 exon 20 insertion mutation, an atypical EGFR mutation (NSCLC only), or HER2 amplification/overexpression - You have received prior standard treatments and your cancer has progressed - Your general health is adequate for receiving an experimental drug **You may NOT be eligible if...** - You do not have an EGFR or HER2 alteration matching the study criteria - You have active brain metastases that are untreated or unstable - You have serious heart, liver, or lung conditions that would make the drug unsafe - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGORIC-114

ORIC-114 oral daily

DRUGChemotherapy drug

21 days for up to 4 cycles

Locations(42)

City of Hope

Duarte, California, United States

City of Hope

Huntington Beach, California, United States

City of Hope

Irvine, California, United States

City of Hope

Long Beach, California, United States

University of California, San Francisco

San Francisco, California, United States

Yale Cancer Center

New Haven, Connecticut, United States

Georgetown University

Washington D.C., District of Columbia, United States

Mayo Clinic

Jacksonville, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

NYU Langone Health Perlmutter Cancer Center

New York, New York, United States

Duke Cancer Institute

Durham, North Carolina, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, United States

Next Oncology

Fairfax, Virginia, United States

Chris O'Brien Lifehouse

Camperdown, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

One Clinical Research, Hollywood Medical Centre

Nedlands, Australia

Sydney Adventist Health

Sydney, Australia

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

The Chinese University of Hong Kong

Shatin, Hong Kong

Sultan Ahmad Shah Medical Centre at International Islamic University Malaysia (IIUM)

Kuantan, Pahang, Malaysia

Pulau Pinang Hospital

George Town, Pulau Pinang, Malaysia

Sarawak General Hospital (SGH)

Kuching, Sarawak, Malaysia

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia

University of Malaya Medical Center (UMMC)

Kuala Lumpur, Malaysia

Medical University of Gdańsk

Gdansk, Poland

Chungbuk University Hospital

Cheongju-si, South Korea

National Cancer Center

Goyang-si, South Korea

Catholic University of Korea, St, Vincent Hospital

Gyeonggi-do, South Korea

Gachon University Hospital

Incheon, South Korea

Seoul National Bundang Hospital

Seongnam-si, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

NEXT Oncology - Barcelona

Barcelona, Spain

Vall d'Hebron Institute of Oncology (VHIO)

Barcelona, Spain

NEXT Oncology - Madrid

Madrid, Spain

National Taiwan University Hospital

Taipei, Taiwan

The Christie NHS Foundation Trust

Manchester, England, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05315700

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