NCT06816992

ORIC-114 in Combination with Subcutaneous Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

Phase 1b Study of ORIC-114 in Combination with Amivantamab in Patients with EGFR Exon20 Insertion Mutant NSCLC

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: ORIC Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to establish the recommended phase 2 dose (RP2D), safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of ORIC-114 in combination with subcutaneous (SC) amivantamab in patients with advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutation.

Detailed description

ORIC-114, is a brain penetrant, selective, orally bioavailable, irreversible small molecule inhibitor designed to target EGFR exon 20 insertion mutations, making it a promising therapeutic candidate for development in patients whose tumors harbor these alterations, including those with CNS metastases. Amivantamab is a bispecific EGFR-directed and MET receptor-directed antibody indicated in combination with carboplatin and pemetrexed for the first line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations and also as a single agent in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. This is an open-label, single arm, multicenter, dose escalation followed by dose expansion study to assess the safety and preliminary antitumor activity of ORIC-114 in combination with SC amivantamab, in patients with locally advanced or metastatic NSCLC harboring an EGFR exon 20 insertion mutations.

Conditions

• Solid Tumors
• EGFR Exon 20 Insertion Mutations
• NSCLC
• EGFR-mutated NSCLC

Interventions

Type	Name	Description
DRUG	ORIC-114 Dose 1 + amivantamab	ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection
DRUG	ORIC-114 Dose 2 + amivantamab	ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection
DRUG	ORIC-114 Dose 3 + amivantamab	ORIC-114 oral daily, amivantamab subcutaneous weekly for 4 weeks followed by every 4 week injection

Timeline

• Start date: 2025-02-27
• Primary completion: 2026-05-01
• Completion: 2027-05-01
• First posted: 2025-02-10
• Last updated: 2025-03-20

Locations

4 sites across 3 countries: United States, Australia, Canada

Regulatory

• FDA-regulated drug study