Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
Trial Parameters
Brief 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.
Eligibility Criteria
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 * C