Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06238843 | 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) | PHASE3 | ACTIVE NOT_RECRUITING | 464 | — | — | Jun 30, 2024 | Dec 31, 2027 | May 13, 2026 | 95 | China, Japan |
Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.
Overall survival (OS) is defined as the time from randomization to death from any cause.
| Arm | Type | Description |
|---|---|---|
| Active Comparator: control arm | ACTIVE_COMPARATOR | 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 |
| IBI343 monotherapy | EXPERIMENTAL | IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles . |
| Name | Type | Description |
|---|---|---|
| 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 . |
Inclusion Criteria: 1. Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures. 2. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ A...