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.
An Open-Label, Phase 1/1b, Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration
ORIC-114 is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor of EGFR and HER2 alterations, including exon 20 insertion mutations.
This is a first-in-human, open-label, single arm, multicenter, dose escalation followed by dose expansion study to establish the recommended phase 2 dose (RP2D) and preliminary antitumor activity of ORIC-114 in patients with advanced solid tumors harboring an EGFR or HER2 alteration who have exhausted available treatment options
The study will begin with dose finding in patients with various solid tumors (Dose Escalation); additional dose expansion cohorts in specific tumor types (Dose Expansion), treatment history, and/or expression of a specific biomarker may be initiated via protocol amendment.
The study will evaluate escalating dose levels of ORIC-114 administered orally, daily in 28-day cycles following an accelerated titration design used for Dose Level 1, after which, escalating doses of ORIC-114 will be administered following an interval 3+3 design.