Comparing ORIC-114 with Chemotherapy drug for solid tumors

Inclusion

• +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
• +Atypical EGFR mutations (NSCLC only) (Appendix 8)
• +HER2 amplification or overexpression (HER2+)
• +CohortCohortA group of participants sharing a characteristic, followed together.Read more → 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 IC: Treatment-naïve NSCLC patients with EGFR exon 20 insertion mutation
• +Cohort ID: Treatment-naïve NSCLC patients with EGFR atypical mutations
• +Cohort IIC: Atypical EGFR mutation, patients may have received a prior EGFR TKI
• +Part I Dose EscalationDose escalationLater groups receive higher amounts than earlier ones, increased step by step.Read more → (CLOSED) Any solid tumor with
• +EGFR exon 20 insertion mutation
• +HER2 exon 20 insertion mutation
• +Previously received and progressed on or after available standard therapies and for whom additional standard therapy is considered unsuitable or intolerable
• +Part I Extension (ONGOING)
• +Part II Dose Optimization (ONGOING): NSCLC patients with
• +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
• +Adequate organ function
• +ECOG performance status of 0 or 1
• +Cohort IB: NSCLC patients with EGFR exon 20 insertion mutation previously treated with chemotherapy and amivantamab
• +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