A Multicenter, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects With Previously Treated, Claudin (CLDN) 18.2-positive, HER2-negative, Gastric or Gastroesophageal Junction Adenocarcinoma (G-HOPE-001)

Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Study ID
NCT06238843
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） — DRUG
    Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles. Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment).
  • IBI343 — DRUG
    Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Study Details

This is a Multicenter, Randomized, Open-label, Phase 3 Study of IBI343 Monotherapy Versus Treatment of Investigator's Choice in Subjects with Previously Treated Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced, Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma to compare the progression free survival (PFS) and overall survival (OS)

Key Dates

Start date
Jun 30, 2024
Status verified
May 2026
Primary completion
Dec 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
464 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Comparator: control arm
    There are three drugs ( irinotecan, paclitaxel,or FTD/TPI (only are applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment)) in active contral arm, the subjects will receive the drug based on investigator's choice
  • Experimental: IBI343 monotherapy
    IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Primary Outcome Measure

progression free survival(PFS) [ Time Frame: within approximately 20 months ]