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

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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), preliminary antitumor ORIC-114 when administered to patients with advanced solid tumors harboring an EGFR or HER2 alteration .

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ORIC Pharmaceuticals

Criteria

Inclusion Criteria:

• Advanced or metastatic solid tumor with one of the following documented EGFR or HER2 insertions or mutations, including EGFR exon 20 insertion mutations, HER2 amplification or overexpression, and HER2 exon 20 insertion mutations, as determined by any local 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 available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable

• Agreement and ability to undergo pretreatment biopsy

• Measurable disease according to RECIST 1.1

• CNS involvement which is either previously treated and controlled, or asymptomatic

• ECOG performance status of 0 or 1

• Adequate organ function

Exclusion Criteria:

• Known EGFR T790M mutation

• Leptomeningeal disease and spinal cord compression

• 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