NCT06732856

Brief Summary

Claudin 18.2 is a promising therapeutic target overexpressed on the surface of gastric cancer cells. The addition of zolbetuximab, the monoclonal antibody targeting Claudin 18.2 to chemotherapy in two recent Phase 3 studies prolonged survival outcomes, indicating that Claudin 18.2 is a valid target in gastric cancer. Asan Medical Center researchers conducted a study on Claudin 18.2 expression in patients with operable gastric cancer and defined moderate to strong claudin expression in more than 75% of tumor cells as Claudin 18.2 overexpression, which was observed in 46.5% of patients with stage I-III tumors. This suggests that zolbetuximab-based treatment may be possible in patients with LAGC. Therefore, The investigator designed a prospective, multicenter, open-label, Phase Ib/II study to determine the efficacy and safety of zolbetuximab/DOS as neoadjuvant chemotherapy in patients with LAGC.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P50-P75 for phase_1

Timeline
20mo left

Started Apr 2025

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Apr 2025Dec 2027

First Submitted

Initial submission to the registry

December 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

April 4, 2025

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 28, 2025

Status Verified

July 1, 2025

Enrollment Period

2.7 years

First QC Date

December 10, 2024

Last Update Submit

July 24, 2025

Conditions

Stomach NeoplasmGastric (Stomach) Cancer

Keywords

NEO-ADJUVANTADJUVANTdistant metastasis limited to lymph node gastric cancerunresectable locally advanced gastric cancer

Outcome Measures

Primary Outcomes (2)

  • Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.(phase II part)

    Evaluation of R0 resection rate.

    1 year

  • Recommended phase 2 dose (RP2D) (phase Ib part)

    Recommended phase 2 dose (RP2D) (phase Ib part)

    1 year

Study Arms (1)

Treatment

EXPERIMENTAL
Drug: zolbetuximabDrug: OxaliplatinDrug: DocetaxelDrug: S-1

Interventions

zolbetuximabDRUG

1. Neoadjuvant treatment : Zolbetuximab 800\*/600 mg/m2 Q3W on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles. (\*Loading dose of zolbetuximab (800 mg/m²) on C1D1, followed by subsequent doses of 600 mg/m² every 3 weeks) 2. Surgery : Total gastrectomy (TG) or distal gastrectomy (DG) accompanied with dissection of the D2 lymph node 3. Adjuvant treatment After 3-8 weeks from surgery, S-1 40/50/60 mg/m2 bid orally on D1-28 plus Zolbetuximab 600 mg/m2 on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment.

Treatment
OxaliplatinDRUG

1\. Neoadjuvant treatment : Zolbetuximab 800\*/600 mg/m2 Q3W on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles. (\*Loading dose of zolbetuximab (800 mg/m²) on C1D1, followed by subsequent doses of 600 mg/m² every 3 weeks) 2. Surgery : Total gastrectomy (TG) or distal gastrectomy (DG) accompanied with dissection of the D2 lymph node 3. Adjuvant treatment After 3-8 weeks from surgery, S-1 40/50/60 mg/m2 bid orally on D1-28 plus Zolbetuximab 600 mg/m2 on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment.

Treatment
DocetaxelDRUG

1\. Neoadjuvant treatment : Zolbetuximab 800\*/600 mg/m2 Q3W on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles. (\*Loading dose of zolbetuximab (800 mg/m²) on C1D1, followed by subsequent doses of 600 mg/m² every 3 weeks) 2. Surgery : Total gastrectomy (TG) or distal gastrectomy (DG) accompanied with dissection of the D2 lymph node 3. Adjuvant treatment After 3-8 weeks from surgery, S-1 40/50/60 mg/m2 bid orally on D1-28 plus Zolbetuximab 600 mg/m2 on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment.

Treatment
S-1DRUG

1\. Neoadjuvant treatment : Zolbetuximab 800\*/600 mg/m2 Q3W on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles. (\*Loading dose of zolbetuximab (800 mg/m²) on C1D1, followed by subsequent doses of 600 mg/m² every 3 weeks) 2. Surgery : Total gastrectomy (TG) or distal gastrectomy (DG) accompanied with dissection of the D2 lymph node 3. Adjuvant treatment After 3-8 weeks from surgery, S-1 40/50/60 mg/m2 bid orally on D1-28 plus Zolbetuximab 600 mg/m2 on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment.

Treatment

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with newly diagnosed, pathologically confirmed, potentially resectable gastric or gastroesophageal junction adenocarcinoma
  • Subjects who are CLDN18.2 positive (VENTANA 43-14A ≥75%)
  • Patients with clinical stage T3-4/N0 or T2-4/N+ on CT according to the American Joint Committee on Cancer (AJCC) 8th edition
  • If suspected by CT, patient who has not been confirmed to have peritoneal seeding by laparoscopy
  • Subject able to provide signed informed consent form, including compliance with the requirements and contraindications specified in the informed consent form (ICF) and in this protocol
  • Patients aged 19 years or older at study entry
  • Patient with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Patient with expected survival \>12 months
  • Weight \>30 kg
  • Patient without neuropathy A. Grade 1 is allowed based on NCI CTCAE v5.0. B. Grade 2 or higher is excluded based on NCI CTCAE v5.0
  • Individual with confirmed adequate normal organ and bone marrow function, as defined in the applicable items below:
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) \>1.5 x 103/mcL (\>1,500 per mm3)
  • Platelet count ≥100 x 109/L
  • Serum bilirubin ≤1.5 x institutional upper limit of normal (ULN)
  • +11 more criteria

You may not qualify if:

  • Patient who received investigational product in another clinical study 2 weeks prior to participation in this clinical study
  • Patient currently enrolled in another clinical study, other than the observational (non-interventional) study or follow-up period of an interventional clinical study.
  • Concomitant chemotherapy, immunotherapy, biologic or hormonal therapy. Hormonal therapies not related to treatment for cancer (e.g., hormone replacement therapy) are allowed.
  • Major surgical procedure within 28 days prior to zolbetuximab administration
  • Distant metastasis including M1 lymph node
  • Patient unable to take oral medication
  • Gastric outlet obstruction and/or severe gastrointestinal hemorrhage that restricts diet without treatment
  • Impaired intestinal absorption, including:
  • Intestinal obstruction
  • Chronic inflammatory bowel disease
  • Operation history of extended bowel resection
  • Gastric dumping syndrome
  • Patient with a history of organ transplant
  • Uncontrolled intercurrent disease including, but not limited to:
  • Ongoing or active infection, congestive heart failure with symptoms, uncontrolled hypertension, unstable angina, arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions accompanied with diarrhea, mental illness or social conditions that prevent compliance with study requirements, significantly increase the risk of adverse reactions, or interfere with written consent
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

zolbetuximabOxaliplatinDocetaxelS 1 (combination)

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Min-Hee Ryu, MD, PhD

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Min-Hee Ryu, MD,PhD

CONTACT

82-2-3010-5935miniryu@amc.seoul.kr

Hyung-Don Kim, MD,PhD

CONTACT

82-2-3010-5935kimhdmd@amc.seoul.kr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 13, 2024

Study Start

April 4, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 28, 2025

Record last verified: 2025-07

Locations

KR(2)