IBI343 Combined With Sintilimab Plus Chemotherapy in Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IBI343, Sintilimab, Oxaliplatin, S-1.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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)
Overview
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
Detailed description
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.
Interventions
- Drug IBI343
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. - Drug Sintilimab
Subjects will receive sintilimab 200mg IV D1 Q3W in 3-week cycles. - Drug Oxaliplatin
Subjects will receive oxaliplatin 130mg/m2 IV D1 Q3W in 3-week cycles. - Drug S-1
Subjects will receive S-1 40-60mg BID PO D1-14 Q3W in 3-week cycles.
Primary outcome measures
- Objective response rate (ORR) [Time frame: up to 2 years]
Secondary outcome measures (4)
- Overall survival (OS) [Time frame: up to 2 years]
- Progression-free survival (PFS) [Time frame: up to 2 years]
- Disease control rate (DCR) [Time frame: up to 2 years]
- Treatment-related adverse event (TRAE) [Time frame: up to 2 years]
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\. Age was 18-75 years at the time of signing the ICF, and gender was unlimited.
3\. Has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (G/GEJ AC).
4\. 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.
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT07025889 · Dragon15