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

NCT06238843 | Recruiting Phase 3

• 1 other identifier: CIBI343A301
• Study Type: interventional
• Target: 450
• Locations: 2 countries
• Sites: 22

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)

Conditions

Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (2)

• progression free survival(PFS)

  Progression-free survival (PFS) is defined as the time from random assignment in the trial to disease progression or death from any cause.

  within approximately 20 months

• overall survival(OS)

  Overall survival (OS) is defined as the time from randomization to death from any cause.

  within approximately 26 months

Secondary Outcomes (12)

• Objective response rate (ORR)

  within approximately 20 months

• disease control rate (DCR)

  within approximately 20 months

• duration of response (DoR)

  within approximately 20 months

• time to response (TTR)

  within approximately 20 months

• area under the curve (AUC)

  within approximately 20 months

Study Arms (2)

Active Comparator: control arm

ACTIVE COMPARATOR

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

Drug: Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI）

IBI343 monotherapy

EXPERIMENTAL

IBI343: Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Drug: IBI343

Interventions

Irinotecan OR Paclitaxel or Trifluridine/tipiracil（ FTD/TPI） DRUG

Drugs: Irinotecan Subjects in the control arm will receive irnotecan 150mg/m2 IV D1, D15, Q4W in 4-weeks cycles. Drugs: Paclitaxel Subjects in the control arm will receive paclitaxel 80mg/m2 IV D1, D8, D15, Q4W in 4-week cycles, Drugs:FTD/TPI Subjects in the control arm will receive FTD/TPI 35 mg/m2 up to a maximum of 80 mg orally twice a day on Days 1 to 5 and Days 8 to 12, Q4W (applicable in US/EU/Japan and other regions where FTD/TPI is approved for GC treatment).

Active Comparator: control arm

IBI343 DRUG

Subjects in the experimental arm will receive IBI343 6mg/kg intravenous infusion (IV) D1, Q3W in 3-week cycles .

Also known as: Arcotatug Tavatecan

IBI343 monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Has HER2-positive (defined as immunohistochemistry \[IHC\] 3+, or IHC 2+ and positive by in situ hybridization) disease.
• Is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study.
• 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).

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (22)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Shikoku Cancer Center

Matsuyama, Ehime, 791-0280, Japan

RECRUITING

Gunma Prefectural Cancer Center

Ota-Shi, Gunma, 373-8550, Japan

RECRUITING

Kure Medical Center And Chugoku Cancer Center

Kure, Hirosima [Hiroshima], 737-0023, Japan

RECRUITING

Teine Keijinkai Hospital

Sapporo, Hokkaido, 006-8555, Japan

RECRUITING

National Hospital Organization Kyushu Cancer Center

Fukuoka, Hukuoka [Fukuoka], 811-1395, Japan

RECRUITING

Hyogo Cancer Center

Akashi, Hyōgo, 673-8558, Japan

RECRUITING

Kobe City Medical Center General Hospital

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

St. Marianna University Hospital

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Yokohama City University Medical Center

Yokohama, Kanagawa, 232-0024, Japan

RECRUITING

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

RECRUITING

Kochi Health Sciences Center

Kochi, Koti [Kochi], 781-8555, Japan

RECRUITING

Kindai University Hospital

Osakasayama-Shi, Osaka, 589-8511, Japan

RECRUITING

The University of Osaka Hospital

Suita-shi, Osaka, 565-0871, Japan

RECRUITING

Saitama Medical University - International Medical Center

Hidaka-Shi, Saitama, 350-1298, Japan

RECRUITING

Saitama Prefectural Cancer Center

Kitaadachi-Gun, Saitama, 362-0806, Japan

RECRUITING

Chiba Cancer Center

Chiba, Tiba [Chiba], 260-8717, Japan

RECRUITING

University of Tokyo Hospital

Bunkyō-Ku, Tokyo, 113-8655, Japan

RECRUITING

Tokyo Metropolitan Komagome Hospital

Bunkyō-Ku, Tokyo, 113-8677, Japan

RECRUITING

Cancer Institute Hospital of JFCR

Koto, Tokyo, 135-8550, Japan

RECRUITING

Gifu University Hospital

Gifu, 501-1194, Japan

RECRUITING

Osaka Prefectural Hospital Organization - Osaka International Cancer Institute

Osaka, 541-8567, Japan

RECRUITING

MeSH Terms

Interventions

Irinotecan; Paclitaxel; Trifluridine

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shijie Liu

CONTACT

+86 18701121959; shijie.liu@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 2, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); JP (21)