A Study of RC48-ADC in Local Advanced or Metastatic Gastric Cancer With the HER2-Overexpression

Sponsor
RemeGen Co., Ltd.
Study ID
NCT04714190
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RC48-ADC — DRUG
    2.5 mg/kg IV every 2 weeks
  • Paclitaxel injection — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)
  • Irinotecan Hydrochloride Injection — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)
  • Apatinib Mesylate Tablets — DRUG
    Administered according to label, as one option for Physician's Choice (determined before randomization)

Study Details

This is a Phase III, randomized, multicenter, open-label clinical trial designed to compare RC48-ADC to physician choice standard treatment in participants with human epidermal growth factor receptor 2 (HER2)-overexpression locally advanced or metastatic gastric cancer.

Key Dates

Start date
Mar 24, 2021
Status verified
Dec 2023
Primary completion
Dec 1, 2024
Completion
Jun 30, 2025

Study Design

Enrollment
351 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RC48-ADC
    Participants will receive RC48-ADC every 2 weeks (Q2W) until investigator assessed loss of clinical benefit, unacceptable toxicity, investigator or participant decision to withdraw from therapy, or death (whichever occurs first).
  • Active Comparator: Physician's Choice
    Participants will receive physician choosed chemotherapy from the following options: Paclitaxel Injection or Irinotecan Hydrochloride Injection or Apatinib Mesylate Tablets oral.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: within approximately 3 years ]

Central Contacts

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