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Can a daily pill target hard-to-treat cancers with EGFR or HER2 mutations?

NCT ID NCT05315700

Disease control Sponsor: ORIC Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

This trial tests an experimental oral drug called ORIC-114 in people with advanced solid tumors that have specific changes in the EGFR or HER2 genes. The study has two parts: first, finding a safe and effective dose, and second, seeing how well the drug works alone or with chemotherapy. Participants receive ORIC-114 daily, and some also get carboplatin and pemetrexed for up to four cycles. The goal is to measure safety, how the drug moves through the body, and whether it shrinks tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ORIC-114, an oral drug taken daily, sometimes combined with chemotherapy drugs carboplatin and pemetrexed
What this could lead to
If it works, ORIC-114 could offer a new targeted treatment option for people with advanced solid tumors that carry certain EGFR or HER2 mutations, potentially slowing or shrinking their cancer.
What could go wrong
This is an early-phase trial, so the drug may not work as hoped or may cause side effects. The results will help determine the right dose and whether further testing is warranted.
Why investors are watching

ORIC Pharmaceuticals is testing ORIC-114, its lead drug candidate, in patients with advanced solid tumors that have EGFR or HER2 alterations. The trial aims to find the right dose and measure safety and anti-tumor activity, both alone and with chemotherapy. For a small company, this readout is a major test of whether its drug works and can support further development.

If it works: A positive result could show that ORIC-114 controls disease in a defined patient group, which may strengthen the company's position and support advancing the drug to later-stage trials. It could also validate the drug's potential as a treatment option for these tumor types.

If it fails: A failure or delay could set back the company's pipeline and hurt its prospects, since ORIC-114 appears to be a central asset. Trials often fail to meet their goals, so a negative outcome is a real possibility.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 350 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented EGFR or HER2 exon 20 insertion mutation or atypical EGFR mutation as determined by any nucleic acid-based diagnostic testing method, or HER2 amplification/overexpression as determined by an immunohistochemistry (IHC) or an in situ hybridization (ISH) test 1. Part I Dose Escalation (CLOSED) Any solid tumor with * EGFR exon 20 insertion mutation * HER2 exon 20 insertion mutation * Atypical EGFR mutations (NSCLC only) (Appendix 8) * HER2 amplification or overexpression (HER2+) * Previously received and progressed on or after available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable 2. Part I Extension (ONGOING) * Cohort IA: Patients with HER2+ breast cancer previously received and progressed on or after available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable * Cohort IB: NSCLC patients with EGFR exon 20 insertion mutation previously treated with chemotherapy and amivantamab * Cohort IC: Treatment-naïve NSCLC patients with EGFR exon 20 insertion mutation * Cohort ID: Treatment-naïve NSCLC patients with EGFR atypical mutations 3. Part II Dose Optimization (ONGOING): NSCLC patients with * Cohort IIA: EGFR exon 20 insertion mutation, patients must have received platinum-based chemotherapy or other chemotherapy regimen if platinum- based chemotherapy was contraindicated. Additionally, patients must be naïve to an EGFR exon 20 targeted agent, ie, must have declined or be ineligible for all available exon 20 targeted therapies with proven benefit * Cohort IIB: HER2 exon 20 insertion mutation, patients must have received platinum-based chemotherapy or other chemotherapy regimen if platinum- based chemotherapy was contraindicated. Additionally, patients must be naïve to a HER2 exon 20 targeted TKI * Cohort IIC: Atypical EGFR mutation, patients may have received a prior EGFR TKI * Agreement and ability to undergo pretreatment biopsy * Measurable disease according to RECIST 1.1 * CNS involvement, which is either previously treated and controlled, or untreated and asymptomatic * ECOG performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Known EGFR T790M mutation * Leptomeningeal disease and spinal cord compression \-- Except if LMD has been reported radiographically on baseline MRI, but is not suspected clinically by the Investigator; the subject must be free of neurological symptoms of LMD * History of class III or IV congestive heart failure or severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the previous 6 months * Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD * Known, symptomatic human immunodeficiency virus (HIV) infection * Known active infection requiring treatment or history of hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients positive for HBsAg but normal HBV DNA level are allowed. * Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes * Any other concurrent serious uncontrolled medical, psychological, or addictive conditions

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Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Center

    RECRUITING

    Seoul, South Korea

  • Catholic University of Korea, St, Vincent Hospital

    RECRUITING

    Gyeonggi-do, South Korea

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, Australia

  • Chungbuk University Hospital

    RECRUITING

    Cheongju-si, South Korea

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope

    RECRUITING

    Huntington Beach, California, 90813, United States

  • City of Hope

    RECRUITING

    Irvine, California, 92618, United States

  • City of Hope

    RECRUITING

    Long Beach, California, 90813, United States

  • Dana Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke Cancer Institute

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Gachon University Hospital

    RECRUITING

    Incheon, South Korea

  • Georgetown University

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Hospital Kuala Lumpur

    RECRUITING

    Kuala Lumpur, Malaysia

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical University of Gdańsk

    RECRUITING

    Gdansk, Poland

  • Moffitt Cancer Center

    RECRUITING

    Tampa, Florida, 33612, United States

  • NEXT Oncology - Barcelona

    RECRUITING

    Barcelona, Spain

  • NEXT Oncology - Madrid

    RECRUITING

    Madrid, Spain

  • NYU Langone Health Perlmutter Cancer Center

    RECRUITING

    New York, New York, 10016, United States

  • National Cancer Center

    RECRUITING

    Goyang-si, South Korea

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

  • Next Oncology

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

  • One Clinical Research, Hollywood Medical Centre

    RECRUITING

    Nedlands, Australia

  • Peter MacCallum Cancer Centre

    RECRUITING

    Melbourne, Australia

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2C4, Canada

  • Pulau Pinang Hospital

    RECRUITING

    George Town, Pulau Pinang, Malaysia

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sarawak General Hospital (SGH)

    RECRUITING

    Kuching, Sarawak, Malaysia

  • Seoul National Bundang Hospital

    RECRUITING

    Seongnam-si, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, South Korea

  • Spartanburg Regional Healthcare System

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

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

    RECRUITING

    Kuantan, Pahang, Malaysia

  • Sydney Adventist Health

    RECRUITING

    Sydney, Australia

  • The Chinese University of Hong Kong

    RECRUITING

    Shatin, Hong Kong

  • The Christie NHS Foundation Trust

    RECRUITING

    Manchester, England, United Kingdom

  • University of California, San Francisco

    RECRUITING

    San Francisco, California, 94122, United States

  • University of Malaya Medical Center (UMMC)

    RECRUITING

    Kuala Lumpur, Malaysia

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Vall d'Hebron Institute of Oncology (VHIO)

    RECRUITING

    Barcelona, Spain

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06510, United States

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