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A Study of RC118 Plus Toripalimab / RC148 in Patients with Locally Advanced Unresectable or Metastatic Solid Tumors

StatusUnknown
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 29, 2025 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary endpoints: 3 to 5 Enrollment target: 64 to 48 · Study sites: 1 to 18 · Interventions: RC118 (Drug), Toripalimab (Drug) to RC118 (Drug), RC148 (Drug), Toripalimab (Drug) · 5 morev3 Show 8 more changesShow less
    • Enrollment target: 64 to 48
    • Study sites: 1 to 18
    • Interventions: RC118 (Drug), Toripalimab (Drug) to RC118 (Drug), RC148 (Drug), Toripalimab (Drug)
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: 13 to 7
    • Study description shortened, about 170 words
    • Study arms: 6 to 2
    • Study title expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study arms: 1 to 6v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open, multi-center, dose escalation and expansion phase I/II study. The Phase I study will explore the tolerability and safety of RC118 in combination with Toripalimab for the treatment of patients with Claudin 18.2-positive, locally advanced unresectable or metastatic malignant solid tumors, and to establish the maximum tolerated dose (MTD) and the recommended dose in phase II clinical trials (RP2D); The Phase II study will evaluate the efficacy and safety of RC118 in combination with Toripalimab or RC148 in patients with locally advanced or metastatic Gastric cancer/Gastro-esophageal junction cancer.
Trial Details
NCT Number NCT06038396
Lead Sponsor RemeGen Co., Ltd.
Conditions Advanced Solid Tumor
Enrollment 48 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov