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A Study of RC148 As a Single Agent and Combination Therapy 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 23, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Dec 31, 2024 to Dec 31, 2025v4
  2. Phase: Phase 1 to Phase 1/2 Enrollment target: 25 to 221 · Primary endpoints: 4 to 5 · Study sites: 4 to 31 · 5 morev3 Show 8 more changesShow less
    • Enrollment target: 25 to 221
    • Primary endpoints: 4 to 5
    • Study sites: 4 to 31
    • Interventions: RC148 (Drug) to RC148 Monotherapy (Drug), RC148/Bevacizumab+RC88 Combination Therapy (Drug), RC148+RC48 Combination Therapy (Drug), RC148+RC88 Combination…
    • Eligibility criteria expanded, about 765 words
    • Secondary endpoints: 13 to 10
    • Study title expanded, about 7 words
    • Study arms: 1 to 8

    See this version in full on ClinicalTrials.gov ↗

  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 4 · Start date changed from estimate of Sep 1, 2023 to Sep 14, 2023 · Eligibility criteria expanded, about 201 wordsv2 Show 3 more changesShow less
    • Study sites: 3 to 4
    • Start date changed from estimate of Sep 1, 2023 to Sep 14, 2023
    • Eligibility criteria expanded, about 201 words

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The primary objective of Phase I of this trial is to evaluate the safety, tolerability, maximum tolerated dose (MTD)/maximum administered dose (MAD) of RC148 in patients with locally advanced unresectable or metastatic solid tumors to determine the recommended Phase II dose (RP2D), and the secondary objective is to evaluate the PK and PD characteristics, immunogenicity and preliminary clinical efficacy of RC148. Phase II will primarily evaluate the efficacy of the RC148 combination regimen, and secondarily will assess safety and tolerability, PK characteristics, and immunogenicity. During the trial, investigators will also evaluate the potential correlation of biomarkers with efficacy.
Trial Details
NCT Number NCT06016062
Lead Sponsor RemeGen Co., Ltd.
Conditions Solid Tumor
Enrollment 221 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov