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

Phase 3

Recruiting

• Conditions: Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）; Drug: IBI343

• Registration Number: NCT06238843
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-25
• Study First Submitted QC: 2024-01-25
• Study First Posted: 2024-02-02
• Study Start: 2024-06-30
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-19
• Last Update Posted: 2025-08-24
• Primary Completion: 2026-12-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator: control arm	Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）	There are three drugs ( irinotecan, paclitaxel,or FTD/TPI (only are applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment)) in active contral arm, the subjects will receive the drug based on investigator's choice
IBI343 monotherapy	IBI343	IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Primary Outcome Measures

Name	Time	Method
progression free survival(PFS)	within approximately 20 months	Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.
overall survival(OS)	within approximately 26 months	Overall survival (OS) is defined as the time from randomization to death from any cause.

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	within approximately 20 months	ORR is defined as the proportion of subjects in the analysis population who achieve confirmed objective response (CR or PR) as assessed by the IRRC per RECIST v1.1.
disease control rate (DCR)	within approximately 20 months	DCR is defined as the proportion of subjects in the analysis population who achieve disease control (CR, PR, or SD) as determined by the IRRC per RECIST v1.1 criteria.
duration of response (DoR)	within approximately 20 months	DoR is defined as the time from the first CR or PR to disease progression or death from any cause, whichever occurs first for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.
time to response (TTR)	within approximately 20 months	TTR is defined as the time from randomization to the first CR or PR for subjects with ORR as assessed by IRRC per RECIST v1.1 criteria.
area under the curve (AUC)	within approximately 20 months	Area under the curve (AUC) is defined as the area under the plasma concentration versus time curve.
maximum concentration (Cmax)	within approximately 20 months	Cmax is the highest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.
time to maximum concentration(Tmax)	within approximately 20 months	The time it takes for a drug to reach the maximum concentration (Cmax) after administration of the drug
trough concentration (Ctrough)	within approximately 20 months	Ctrough is the lowest concentration of a drug in the blood after the drug has been administered and before the administration of a second dose.
clearance (CL)	within approximately 20 months	The clearance is defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time.
volume of distribution (V)	within approximately 20 months	Volume of distribution (Vd) is defined as the arrangement or rate of incidence of a drug in the body in relation to the measured plasma concentration.
Incidence of anti-drug antibody (ADA)	within approximately 20 months	Incidence of anti-drug antibody (ADA) is defined as the sum of both treatmentinduced (post-baseline ADA-positive only) and treatment-boosted ADA.
neutralizing antibody (NAb)	within approximately 20 months	Neutralizing antibodies (NAb) are a subset of binding ADA that bind to the drug and inhibit its pharmacological function by preventing target binding.

Trial Locations

Locations (22)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Shikoku Cancer Center; 🇯🇵 Matsuyama-Shi, Ehime, Japan

Gunma Prefectural Cancer Center; 🇯🇵 Ota-Shi, Gunma, Japan

Kure Medical Center And Chugoku Cancer Center; 🇯🇵 Kure, Hirosima [Hiroshima], Japan

Teine Keijinkai Hospital; 🇯🇵 Sapporo-shi, Hokkaido, Japan

National Hospital Organization Kyushu Cancer Center; 🇯🇵 Fukuoka-shi, Hukuoka [Fukuoka], Japan

Hyogo Cancer Center; 🇯🇵 Akashi City, Hyogo, Japan

Kobe City Medical Center General Hospital; 🇯🇵 Kobe-city, Hyogo, Japan

St. Marianna University Hospital; 🇯🇵 Kawasaki, Kanagawa, Japan

Yokohama City University Medical Center; 🇯🇵 Yokohama-Shi, Kanagawa, Japan

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