ClinicaliQ Trial Snapshot
- Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration — Recruiting • Phase I • Oncology • NCT05315700.
- ORIC-114 is being tested as a novel therapeutic agent either alone or combined with chemotherapy in patients with advanced solid tumors carrying EGFR or HER2 alterations, with primary objectives of determining the recommended Phase 2 dose, maximum tolerated dose, and safety profile.
- Eligible patients have advanced solid tumors with documented EGFR or HER2 alterations; specific eligibility criteria regarding prior treatment lines, performance status, and organ function would determine individual suitability for enrolment.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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 * Cohort IB: NSCLC patients with EGFR exon 20 insertion mutation previously treated with chemotherapy and amivantamab * Cohort IC: Treatment-naïve NSCLC patients with EGFR exon 20 insertion mutation * Cohort ID: Treatment-naïve NSCLC patients with EGFR atypical mutations 3. Part II Dose Optimization (ONGOING): NSCLC patients with * Cohort IIA: EGFR exon 20 insertion mutation,…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.