Actively Recruiting
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Led by ORIC Pharmaceuticals · Updated on 2025-08-05
350
Participants Needed
42
Research Sites
285 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Confirmed locally advanced or metastatic solid tumor with documented EGFR or HER2 exon 20 insertion mutations, atypical EGFR mutations, or HER2 amplification/overexpression
- For Part I Dose Escalation: tumors with EGFR exon 20 insertion, HER2 exon 20 insertion, atypical EGFR mutations (NSCLC only), or HER2 amplification/overexpression
- Patients must have progressed on or after standard therapies and be unsuitable or intolerant to further standard treatment
- Agreement and ability to undergo pretreatment biopsy
- Measurable disease according to RECIST 1.1
- CNS involvement must be either treated and controlled or untreated and asymptomatic
- ECOG performance status of 0 or 1
- Adequate organ function
You will not qualify if you...
- Known EGFR T790M mutation
- Leptomeningeal disease or spinal cord compression unless radiographically present but without neurological symptoms
- History of class III or IV congestive heart failure, severe non-ischemic cardiomyopathy, unstable or poorly controlled angina, myocardial infarction, or ventricular arrhythmia within the past 6 months
- Past history or evidence of active interstitial lung disease (ILD), drug-induced ILD, or radiation pneumonitis requiring steroid treatment
- Known symptomatic HIV infection
- Active infection requiring treatment or history of hepatitis B or C infection; patients positive for HBsAg with normal HBV DNA are allowed
- Active gastrointestinal disease such as Crohn's disease, ulcerative colitis, or malabsorption syndromes
- Any other serious uncontrolled medical, psychological, or addictive conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 42 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
City of Hope
Huntington Beach, California, United States, 90813
Actively Recruiting
3
City of Hope
Irvine, California, United States, 92618
Actively Recruiting
4
City of Hope
Long Beach, California, United States, 90813
Actively Recruiting
5
University of California, San Francisco
San Francisco, California, United States, 94122
Actively Recruiting
6
Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
Georgetown University
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
10
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
11
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
12
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
13
NYU Langone Health Perlmutter Cancer Center
New York, New York, United States, 10016
Actively Recruiting
14
Duke Cancer Institute
Durham, North Carolina, United States, 27710
Actively Recruiting
15
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
16
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
Actively Recruiting
17
Next Oncology
Fairfax, Virginia, United States, 22031
Actively Recruiting
18
Chris O'Brien Lifehouse
Camperdown, Australia
Actively Recruiting
19
Peter MacCallum Cancer Centre
Melbourne, Australia
Actively Recruiting
20
One Clinical Research, Hollywood Medical Centre
Nedlands, Australia
Actively Recruiting
21
Sydney Adventist Health
Sydney, Australia
Actively Recruiting
22
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
23
The Chinese University of Hong Kong
Shatin, Hong Kong
Actively Recruiting
24
Sultan Ahmad Shah Medical Centre at International Islamic University Malaysia (IIUM)
Kuantan, Pahang, Malaysia
Actively Recruiting
25
Pulau Pinang Hospital
George Town, Pulau Pinang, Malaysia
Actively Recruiting
26
Sarawak General Hospital (SGH)
Kuching, Sarawak, Malaysia
Actively Recruiting
27
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Actively Recruiting
28
University of Malaya Medical Center (UMMC)
Kuala Lumpur, Malaysia
Actively Recruiting
29
Medical University of Gdańsk
Gdansk, Poland
Actively Recruiting
30
Chungbuk University Hospital
Cheongju-si, South Korea
Actively Recruiting
31
National Cancer Center
Goyang-si, South Korea
Actively Recruiting
32
Catholic University of Korea, St, Vincent Hospital
Gyeonggi-do, South Korea
Actively Recruiting
33
Gachon University Hospital
Incheon, South Korea
Actively Recruiting
34
Seoul National Bundang Hospital
Seongnam-si, South Korea
Actively Recruiting
35
Asan Medical Center
Seoul, South Korea
Actively Recruiting
36
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
37
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
38
NEXT Oncology - Barcelona
Barcelona, Spain
Actively Recruiting
39
Vall d'Hebron Institute of Oncology (VHIO)
Barcelona, Spain
Actively Recruiting
40
NEXT Oncology - Madrid
Madrid, Spain
Actively Recruiting
41
National Taiwan University Hospital
Taipei, Taiwan
Actively Recruiting
42
The Christie NHS Foundation Trust
Manchester, England, United Kingdom
Actively Recruiting
Research Team
O
ORIC Clinical
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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