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Study of ORIC-114 in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv9
  2. Primary completion date: Mar 2025 to Sep 2026 Study sites: 34 to 42 · Completion date: Mar 2026 to Sep 2027 · Eligibility criteria expanded, about 9 wordsv8 Show 3 more changesShow less
    • Study sites: 34 to 42
    • Completion date: Mar 2026 to Sep 2027
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 9 of 34 sitesv7
  4. Enrollment target: 280 to 350 Study sites: 26 to 34 · Eligibility criteria expanded, about 120 words · Study description expanded, about 3 words · 1 morev6 Show 4 more changesShow less
    • Study sites: 26 to 34
    • Eligibility criteria expanded, about 120 words
    • Study description expanded, about 3 words
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  5. Phase: Phase 1 to Phase 1/2 Enrollment target: 42 to 280 · Primary completion date: Mar 2024 to Mar 2025 · Study sites: 18 to 26 · 6 morev5 Show 9 more changesShow less
    • Enrollment target: 42 to 280
    • Primary completion date: Mar 2024 to Mar 2025
    • Study sites: 18 to 26
    • Completion date: Mar 2025 to Mar 2026
    • Interventions: ORIC-114 (Drug) to Chemotherapy drug (Drug), ORIC-114 (Drug)
    • Eligibility criteria expanded, about 67 words
    • Study description expanded, about 26 words
    • Study arms: 1 to 2
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 14 to 18v4
  2. Study sites: 8 to 14 Primary completion date: Sep 2023 to Mar 2024 · Completion date: Dec 2023 to Mar 2025 · Eligibility criteria expanded, about 37 words · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Sep 2023 to Mar 2024
    • Completion date: Dec 2023 to Mar 2025
    • Eligibility criteria expanded, about 37 words
    • Study description shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Secondary endpoints: details revised at 6 of 6 entries Site details revised at 5 of 8 sitesv2 Show 1 more changeShow less
    • Site details revised at 5 of 8 sites
  1. 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) 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.
Trial Details
NCT Number NCT05315700
Lead Sponsor ORIC Pharmaceuticals
Conditions Solid Tumors
Enrollment 350 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov