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)

Korábbi kezelés

• 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).

Más betegség

• Has HER2-positive (defined as immunohistochemistry [IHC] 3+, or IHC 2+ and positive by in situ hybridization) disease.

Egyéb

• Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.

• 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.