To hear about similar clinical trials, please enter your email below
Trial Title:
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
NCT ID:
NCT06238843
Condition:
Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Esophageal Neoplasms
Paclitaxel
Irinotecan
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Enrolling by invitation
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
irinotecan
Description:
Subjects in the contral arm will receive irinotecan 125mg/m2 IV D1, D8, Q3W in 3-weeks
cycles or 150mg/m2 IV D1, Q2W in 2-week cycles
Arm group label:
control arm
Intervention type:
Drug
Intervention name:
IBI343
Description:
IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion
(IV) D1, Q3W in 3-week cycles
Arm group label:
experimental arm
Intervention type:
Drug
Intervention name:
paclitaxel
Description:
Subjects in the contral arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week
cycles.
Arm group label:
control arm
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)
Criteria for 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 inhibitor-based 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Start date:
June 30, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Innovent Biologics (Suzhou) Co. Ltd.
Agency class:
Industry
Source:
Innovent Biologics (Suzhou) Co. Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06238843
