Ph 1/2 Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
a study on Solid Tumor HER2 Neoplasms
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Diego, California and other locations
- Dates
- study startedcompletion around
Description
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.
Official Title
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
Details
ORIC-114 is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor designed to target EGFR and HER2 alterations, making it a promising therapeutic candidate for development in patients whose tumors harbor these alterations, including those with CNS metastases.
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.
Keywords
Solid Tumors, EGFR exon 20 insertion mutation, Atypical EGFR mutation, HER2 exon 20 insertion mutation, HER2 amplification/overexpression, NSCLC, Neoplasms, Carboplatin, Pemetrexed, ORIC-114, Chemotherapy drug
Eligibility
You can join if…
Open to people ages 18 years and up
- 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
- Previously received and progressed on or after available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable
- In Parts I and II NSCLC patients must have received platinum-based chemotherapy or other chemotherapy regimen if platinum-based chemotherapy is contraindicated
- Part II Dose Optimization Cohort IIA: patients must either be naïve to an EGFR exon 20 targeted agent or only have received prior amivantamab, Cohort IIB: patients must be naïve to a HER2 targeted TKI, Cohort IIC: patients may have received a prior EGFR TKI
- In Part III, patients may have received any number of prior treatments
- 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
You CAN'T join if...
- 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
Locations
- University of California, San Diego
not yet accepting patients
San Diego California 92093 United States - City of Hope
not yet accepting patients
Irvine California 92618 United States - University of California, San Francisco
accepting new patients
San Francisco California 94122 United States - Next Oncology
accepting new patients
Fairfax Virginia 22031 United States
Details
- Status
- accepting new patients at some sites,
but this study is not currently recruiting here - Start Date
- Completion Date
- (estimated)
- Sponsor
- ORIC Pharmaceuticals
- ID
- NCT05315700
- Phase
- Phase 1/2 research study
- Study Type
- Interventional
- Participants
- Expecting 280 study participants
- Last Updated