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

Last updated: July 25, 2024
Sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Overall Status: Active - Enrolling

Phase

3

Condition

Esophageal Disorders

Digestive System Neoplasms

Adenocarcinoma

Treatment

paclitaxel

IBI343

irinotecan

Clinical Study ID

NCT06238843
CIBI343A301
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Able and willing to sign a written Informed Consent Form (ICF) and to comply withprotocol-specified visits and related procedures.

  2. Has histopathologically confirmed unresectable locally advanced or metastaticadenocarcinoma 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 incombination with platinum or fluoropyrimidines, paclitaxel/docetaxel, irinotecan). Aprior (neo)adjuvant systemic therapy that ended within 6 months prior to diseaserelapse is defined as the first line therapy. The subject has ≤ 4 prior lines ofsystemic 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

Exclusion Criteria:

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

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

  3. Has a history of treatment with topoisomerase inhibitor-based antibody-drugconjugate(s).

  4. Has received the last dose of an anti-cancer therapy (including traditional Chinesemedicine indicated for gastric cancer in the package insert, but excluding herbalprescriptions) within 4 weeks or 5 half-lives (whichever is shorter) prior to thefirst 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 affectresponse assessment is allowed).

Study Design

Total Participants: 450
Treatment Group(s): 3
Primary Treatment: paclitaxel
Phase: 3
Study Start date:
June 30, 2024
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.