CI

At a glance

ClinicalIndex Comparison Record
Phase 2Recruiting· 350 target
Drug / intervention
ORIC-114 +1 moredrug
Likely dose
Not stated in record
Key inclusion· 12
  • ✓Histologically or cytologically confirmed locally advanced or metastatic solid tumor
  • ✓EGFR or HER2 exon 20 insertion mutation
  • ✓Atypical EGFR mutation
  • ✓HER2 amplification/overexpression by IHC or ISH
Key exclusion· 8
  • ✕Known EGFR T790M mutation
  • ✕Leptomeningeal disease and spinal cord compression (except asymptomatic LMD on imaging if clinically unsuspected)
  • ✕History of class III or IV congestive heart failure, severe cardiomyopathy, unstable angina, MI, or ventricular arrhythmia within 6 months
  • ✕Interstitial lung disease, drug-induced ILD, or radiation pneumonitis requiring steroids

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05315700
NCT05315700Phase 2RecruitingHigh MomentumUpdated 10mo ago
Long Recruiting
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An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

ORIC Pharmaceuticals·interventional·Posted Apr 7, 2022·Updated Aug 5, 2025

In Brief

A Phase 2 clinical trial evaluating ORIC-114 and Chemotherapy drug for Solid Tumors. Currently recruiting, targeting 350 participants across 42 sites in 10 countries.

Signals

Enrolling ahead of pace

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumors
CountriesAustralia, Canada, Hong Kong, Malaysia, Poland, South Korea, Spain, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 2Recruiting
20232024202520262027
First PostedApr 7, 2022
Enrollment StartMar 10, 2022
Primary CompletionSep 1, 2026
Study CompletionSep 1, 2027
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 4.2 years agoPrimary completion in 2 months

Interventions

ORIC-114drug

ORIC-114 oral daily

Chemotherapy drugdrug

21 days for up to 4 cycles