Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
NCT ID: NCT05315700
Last Updated: 2025-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
350 participants
INTERVENTIONAL
2022-03-10
2027-09-30
Brief Summary
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Detailed Description
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This is a first-in-human, open-label, single arm, multicenter, dose escalation study of ORIC-114 as a single agent (Part I), followed by dose optimization (Part II) to establish the recommended phase 2 dose (RP2D) and antitumor activity of ORIC-114 in patients with advanced solid tumors harboring an EGFR or HER2 alteration who have exhausted available treatment options. After the optimal RP2D has been determined, Phase 2 will be initiated via protocol amendment to add one or more expansion cohorts of patients with specific tumor types, treatment history, and/or expression of a specific biomarker to evaluate the antitumor activity of ORIC-114.
After completion of Part I dose escalation, Part III, a dose escalation study of ORIC-114 in combination with chemotherapy (carboplatin-pemetrexed) may be initiated to establish the RP2D and/or MTD and antitumor activity for the combination (US sites only).
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation and Dose Optimization
ORIC-114 dosed orally on a continuous once daily dosing regimen in 28-day cycles.
ORIC-114
ORIC-114 oral daily
Combination Dose Escalation
ORIC-114 dosed orally on a continuous once daily dosing regimen in 21-day cycles.
ORIC-114
ORIC-114 oral daily
Chemotherapy drug
21 days for up to 4 cycles
Interventions
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ORIC-114
ORIC-114 oral daily
Chemotherapy drug
21 days for up to 4 cycles
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
* 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
18 Years
ALL
No
Sponsors
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ORIC Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Pratik S. Multani, MD, MS
Role: STUDY_DIRECTOR
ORIC Pharmaceuticals
Locations
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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
Countries
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Central Contacts
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Other Identifiers
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ORIC-114-01
Identifier Type: -
Identifier Source: org_study_id
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