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
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
Innovent Biologics (Suzhou) Co. Ltd.
450 participants
Jun 30, 2024
INTERVENTIONAL
Conditions
Summary
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)
Eligibility
Inclusion Criteria6
- Able and willing to sign a written Informed Consent Form(ICF) and to comply with protocol-specified visits and related procedures.
- Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
- Has received and progressed on at least 2 lines of systemic therapy (anti-PD-(L)1 in combination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). A prior (neo)adjuvant systemic therapy that ended within 6 months prior to disease relapse is defined as the first line therapy. The subject has ≤ 4 prior lines of systemic therapy.
- Has histopathologically confirmed CLDN18.2-positive disease.
- Is a man or woman of 18 years of age or older at the time of signing the ICF.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
Exclusion Criteria5
- Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.
- Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
- Has a history of treatment with topoisomerase inhibitorbased antibody-drug conjugate(s).
- Has received the last dose of an anti-cancer therapy (including traditional Chinese medicine indicated for gastric cancer in the package insert, but excluding herbal prescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to the first dose of study treatment.
- Plans to receive other anti-cancer therapy during treatment with the study drug (palliative radiotherapy for symptomatic (e.g., pain) relief that does not affect response assessment is allowed).
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Interventions
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).
Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .
Locations(22)
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NCT06238843