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

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: May 2026 to Dec 2026 Completion date: May 2027 to Dec 2027v5 Show 1 more changeShow less
    • Completion date: May 2027 to Dec 2027
  2. Start date changed from estimate of Feb 2025 to Feb 27, 2025v4
  3. Study sites: 5 to 4v3
  4. Trial status: Not Yet Recruiting to Recruiting Interventions: ORIC-114 Dose 1 + amivantamab (Drug), ORIC-114 Dose 2 + amivantamab (Drug), ORIC-114 Dose 3 + amivanatamab (Drug) to ORIC-114 Dose 1 + amivantamab (Drug), ORIC-114 Dose 2 + amivantamab (Drug), ORIC-114 Dose 3 + amivantamab (Drug) · Site details revised at 5 of 5 sitesv2 Show 2 more changesShow less
    • Interventions: ORIC-114 Dose 1 + amivantamab (Drug), ORIC-114 Dose 2 + amivantamab (Drug), ORIC-114 Dose 3 + amivanatamab (Drug) to ORIC-114 Dose 1 + amivantamab (Drug), ORIC-114 Dose 2 + amivantamab (Drug), ORIC-114 Dose 3 + amivantamab (Drug)
    • Site details revised at 5 of 5 sites
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06816992
Lead Sponsor ORIC Pharmaceuticals
Collaborators: Janssen Research and Development LLC
Conditions Solid Tumors, EGFR Exon 20 Insertion Mutations, NSCLC, EGFR-mutated NSCLC
Enrollment 76 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov