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NCT Number: NCT07025889

IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer

This is a Single-arm, Open-label, Phase 1b/2 Study of IBI343 Combined with Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location status: Recruiting

Location contact

Shanghai Jiao Tong University School of Medicine

CONTACT

[email protected]

021-64370045

About this study

This trial is a phase Ib/II study to evaluate the safety, tolerability and efficacy of IBI343 in combination with sintilimab and chemotherapy in patients with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma. In dose-escalation stage, patients with CLDN 18.2-positive, HER2-negative were treated with IBI 343, sintilimab, and chemotherapy (oxaliplatin, S-1) as first-line therapy, which followed a 3+3 design. The dose expansion stage aimed to further investigate the safety and preliminary efficacy of recommended phase II dose (RP2D), including Cohort 1 and Cohort 2. In Cohort 1, 25 patients with CLDN18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma will be enrolled. In Cohort 2, 15 patients with CLDN18.2-positive, HER2-negative gastric signet-ring cell carcinoma will be enrolled.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Able and willing to sign a written Informed Consent Form (ICF) and to comply with protocol-specified visits and related procedures.
  • Age was 18-75 years at the time of signing the ICF, and gender was unlimited.
  • Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
  • No received systemic therapy. 5. Has histopathologically confirmed CLDN18.2-positive disease. 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.
  • 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 inhibitor-based antibody-drug conjugate(s).

Treatment and study plan

IBI343

Drug

Subjects in the phase 1b stage will receive IBI343 3/4.5/6mg/kg intravenous infusion (IV) D1 Q3W in 3-week cycles.

Subjects in the phase 2 stage will receive IBI343 RP2D intravenous IV D1 Q3W in 3-week cycles.

Sintilimab

Drug

Subjects will receive sintilimab 200mg IV D1 Q3W in 3-week cycles.

Oxaliplatin

Drug

Subjects will receive oxaliplatin 130mg/m2 IV D1 Q3W in 3-week cycles.

S-1

Drug

Subjects will receive S-1 40-60mg BID PO D1-14 Q3W in 3-week cycles.

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: up to 2 years

    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 criteria.

Secondary outcomes

  1. Overall survival (OS)

    Time frame: up to 2 years

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

  2. Progression-free survival (PFS)

    Time frame: up to 2 years

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

  3. Disease control rate (DCR)

    Time frame: up to 2 years

    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.

  4. Treatment-related adverse event (TRAE)

    Time frame: up to 2 years

    Safety evaluation, such as hematotoxicity, hepatotoxicity, and renal function lab test, done continuously during treatment and the level of serum creatinine will be evaluated by using CTCAE 5.0 during study.

Study contacts

Contact information is provided by the study sponsor or research team.

Ruijin Hospital, Shanghai Jiao Tong University School of Medic

CONTACT

[email protected]

021-64370045

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine

Registry information

Official study title

IBI343 Combined With Sintilimab Plus Chemotherapy in Previously Untreated, Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (Dragon15)

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 18, 2025
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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