NCT06816992 ORIC-114 in Combination With Subcutaneous Amivantamab in Patients With EGFR Exon20 Insertion Mutant NSCLC
| NCT ID | NCT06816992 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ORIC Pharmaceuticals |
| Condition | Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2025-02-27 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 76 participants in total. It began in 2025-02-27 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed metastatic NSCLC with a documented EGFR exon 20 insertion mutation as determined locally by any nucleic acid-based diagnostic testing method; all tests should be performed in a CLIA certified or equivalently accredited laboratory * Prior Therapies: 1. Dose Escalation: Patients may have previously received and progressed on or after platinum-based chemotherapy or may be treatment naïve 2. Dose Expansion: Patients must not have received any prior therapy; at time of enrollment, patients must decline, or be ineligible for all available standard of care therapies with proven benefit * Agreement and ability to undergo a pretreatment biopsy, provided the procedure is clinically feasible and not deemed unsafe by the investigator * Measurable disease according to RECIST 1.1 * Patients with asymptomatic CNS metastases are eligible * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function Exclusion Criteria: * Known small cell lung cancer transformation * Leptomeningeal disease * Spinal cord compression not definitively treated with surgery or radiation * Prior immunotherapy * Past medical history of interstitial lung disease (ILD), drug induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD * Active gastrointestinal disease (eg, Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would reasonably impact absorption of ORIC-114
Contact & Investigator
Pratik S. Multani, MD, MS
STUDY DIRECTOR
ORIC Pharmaceuticals
Frequently Asked Questions
Who can join the NCT06816992 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06816992 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06816992 currently recruiting?
Yes, NCT06816992 is actively recruiting participants. Contact the research team at clinical@oricpharma.com for enrollment information.
Where is the NCT06816992 trial being conducted?
This trial is being conducted at New York, United States, Fairfax, United States, Melbourne, Australia, Toronto, Canada.
Who is sponsoring the NCT06816992 clinical trial?
NCT06816992 is sponsored by ORIC Pharmaceuticals. The principal investigator is Pratik S. Multani, MD, MS at ORIC Pharmaceuticals. The trial plans to enroll 76 participants.