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A Study of RC118 in Patients with Locally Advanced Unresectable or Metastatic Malignant Solid Tumors

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 27, 2025 (before its estimated September 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study Identification, Study Status, Oversightv5
  2. Primary completion date: Dec 31, 2023 to Sep 30, 2025 Study sites: 1 to 2 · Completion date: Dec 1, 2024 to Dec 1, 2025 · Eligibility criteria expanded, about 58 words · 1 morev4 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Completion date: Dec 1, 2024 to Dec 1, 2025
    • Eligibility criteria expanded, about 58 words
    • Secondary endpoints: 5 to 6

    See this version in full on ClinicalTrials.gov ↗

  3. Re-verified, no change to tracked fieldsv3
  4. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Feb 2022 to Mar 3, 2022 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Feb 2022 to Mar 3, 2022
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In Phase I, This study will explore the tolerability and safety of RC118 in patients with locally advanced unresectable or metastatic malignant solid tumors with positive Claudin 18.2 expression, and determine the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); In Phase IIa, to explore the clinical effectiveness and safety of long-term use of RC118 at RP2D doses for patients with different tumor types。
Trial Details
NCT Number NCT05205850
Lead Sponsor RemeGen Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 135 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov