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

Launched by INNOVENT BIOLOGICS (SUZHOU) CO. LTD. · Jan 25, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called IBI343 for people with advanced stomach or gastroesophageal junction cancer that has come back or spread, and who have already tried other treatments. The trial is comparing IBI343 alone to other treatments chosen by the doctor to see which works better at slowing down the cancer and helping people live longer. The main goal is to find out if IBI343 can improve the time patients live without their cancer getting worse and their overall survival.

To join this study, participants need to be adults with a specific type of stomach or gastroesophageal cancer that tests positive for a protein called CLDN18.2 and negative for another marker called HER2. They should have already tried at least two different cancer treatments but still have active disease. People in good general health who can follow the study visits and procedures may be eligible. During the trial, participants will receive either IBI343 or another treatment selected by their doctor, and their health will be closely monitored. The study is currently recruiting patients, and those interested should talk to their doctor to see if they qualify.

Gender

ALL

Eligibility criteria

• 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 AC).
• • 3. 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.
• • 4. Has histopathologically confirmed CLDN18.2-positive disease.
• • 5. Is a man or woman of 18 years of age or older at the time of signing the ICF.
• • 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
• Exclusion Criteria:
• • 1. Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.
• • 2. Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
• • 3. Has a history of treatment with topoisomerase inhibitorbased antibody-drug conjugate(s).
• • 4. 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.
• • 5. 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).