Stomach NeoplasmPhase 1/2NEO-CLAUDNCT06732856
A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer
A Phase 1/2 study testing zolbetuximab, Oxaliplatin and Docetaxel in people with Stomach Neoplasm and Gastric (Stomach) Cancer, run by Asan Medical Center at 2 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Stomach Neoplasm, Gastric (Stomach) Cancer
- What is being tested?
- zolbetuximab, Oxaliplatin and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 4 Apr 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 26Show fewer
- 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)
- AST (SGOT)/ALT (SGPT) ≤2.5 x institutional ULN
- Measured creatinine clearance (CL) >40 mL/min or creatinine CL >40 mL/min as calculated by Cockcroft-Gault formula (Cockcroft and Gault 1976) or based on a 24-hour urine sample for determination of creatinine clearance
- Male creatinine CL (mL/min) = Weight (kg) x (140 - Age) / 72 x Serum creatinine (mg/dL)
- Female creatinine CL (mL/min) = Weight (kg) x (140 - Age) / 72 x Serum creatinine (mg/dL) x 0.85
- Evidence of menopause, or negative urine/blood pregnancy test in premenopausal women; women with amenorrhea for at least 12 months without any other medical cause are considered menopausal. The following age requirements apply:
- A woman under age 50 is considered menopausal if 1) she has had amenorrhea for at least 12 months without hormone therapy, and 2) her LH and FSH blood levels are at menopausal levels or she has undergone bilateral oophorectomy, hysterectomy, etc.
- A woman aged 50 years or older is considered menopausal if
- she has had amenorrhea for at least 12 months without hormone therapy, or
- she became menopause after 1 year of amenorrhea following radiation or anticancer treatment, or
- she has undergone bilateral oophorectomy, bilateral salpingectomy, hysterectomy, etc.
- Patient who is willing and able to comply with the protocol during the study, including treatments and tests such as scheduled visits, follow-up, etc.
Who cannot join
- 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
Show all 28Show fewer
- 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
- History of other primary malignancy, with the exception of:
- Patient who is at low risk of recurrence with disease-free status for at least 5 years prior to starting chemotherapy due to curative treatment
- Patient who is currently disease-free with cured skin cancer (except melanoma) or lentigo maligna
- Patient who is currently disease-free with cured in situ carcinoma
- Patient with a history of active congenital immunodeficiency
- Active infection, such as tuberculosis, confirmed by history, physical examination, radiographic findings, and TB testing per local standards, or HIV.
- Tuberculosis: History, physical examination, or radiological findings suggestive of active tuberculosis, or tuberculosis confirmed by tuberculosis testing per local standards (active TB is excluded and old TB is allowed)
- For HBV infection, the patient may be enrolled if appropriately treated with antiviral agents, etc.
- HIV
- HIV Ag/Ab: If reactive, exclude
- HIV Ag/Ab: If non-reactive, enroll
- Pregnant or lactating woman and man or woman of childbearing potential who is unwilling to use effective contraception (from the screening period to 90 days after the last dose of zolbetuximab)
- Individual with known allergy and hypersensitivity to the investigational product or its components
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea2 sites, 2 recruiting
- Recruiting
Asan Medical Center
Seoul, 05505
Min-Hee Ryu, MD, PhD, 82-2-3010-5935, miniryu@amc.seoul.kr
- Recruiting
Asan Medical Center
Seoul, 05505
About this study
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.
Read the detailed description
Although the global incidence and mortality of gastric cancer has declined in recent decades, gastric cancer is the fifth most common cancer and the third leading cause of cancer-related death. Surgical resection is the main treatment for patients with localized gastric cancer. However, postoperative recurrences are common, and approximately 40% of patients experience recurrences 2 years after surgery.
Various adjuvant therapies have been studied over the past decades to improve the rate of postoperative recurrences. Perioperative chemotherapy and postoperative chemoradiotherapy or adjuvant chemotherapy has been shown to improve overall survival in patients with resectable gastric cancer. The preferred treatment strategy is chosen according to the expected locoregional control after surgery, and tends to vary depending on the geographical location.
Two large randomized, controlled, Phase 3 trials in East Asia investigated the efficacy of S-1 for 1 year or capecitabine and oxaliplatin (XELOX) for 6 months as adjuvant chemotherapy following D2 gastrectomy compared to D2 gastrectomy alone in patients with resectable gastric cancer. Both studies showed an apparent benefit of adjuvant chemotherapy versus surgery alone in survival, with 5-year overall survival rates of 70 to 80% in patients receiving adjuvant chemotherapy and 60 to 70% in patients receiving surgery alone. Based on these results, D2 gastrectomy with S-1 or XELOX as adjuvant chemotherapy is the treatment strategy generally selected for patients with resectable gastric cancer in East Asia. However, approximately 30 to 35% of patients experience disease recurrence despite the addition of adjuvant chemotherapy, suggesting that a better treatment strategy needs to be developed in this clinical setting.
One of the strategies for improving survival outcomes of locally advanced gastric cancer may be the introduction of neoadjuvant chemotherapy. Recently, the pivotal phase 3 PRODIGY and RESOLVE studies have demonstrated survival benefits of adding neoadjuvant chemotherapy to surgery followed by adjuvant chemotherapy over up-front surgery followed by adjuvant chemotherapy in Asian patients. Based on these results, neoadjuvant chemotherapy is considered one of the viable options for patients with locally advanced gastric cancer.
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.
< Primary objective(s)>
- RP2D (phase Ib part)
- Pathologic complete regression rate (pCR) (phase II part)
< Secondary objective(s)>
- Progression-free survival by RECIST v1.1
- Overall survival (OS)
- Overall response rate (ORR) during by RECIST v 1.1
- Disease control rate (DCR) by RECIST v 1.1
- Safety profiles by
- Conditions
- Stomach Neoplasm, Gastric (Stomach) Cancer
- Being tested
- zolbetuximab, Oxaliplatin, Docetaxel, S-1
- Keywords
- NEO-ADJUVANT, ADJUVANT, distant metastasis limited to lymph node gastric cancer, unresectable locally advanced gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zolbetuximabDrug
- 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)
- Surgery : Total gastrectomy (TG) or distal gastrectomy (DG) accompanied with dissection of the D2 lymph node
- 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.
OxaliplatinDrug
- 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.
DocetaxelDrug
- 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.
S-1Drug
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: zolbetuximab; Drug: Oxaliplatin; Drug: Docetaxel; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.(phase II part)
Evaluation of R0 resection rate.
Measured: 1 year
Recommended phase 2 dose (RP2D) (phase Ib part)
Recommended phase 2 dose (RP2D) (phase Ib part)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start4 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min-Hee Ryu, Asan Medical Center
- Investigators
- Min-Hee Ryu, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732856
- Sponsor's protocol ID
- AMC2402
- Acronym
- NEO-CLAUD
- Status last verified
- Jul 2025
- First submitted
- 10 Dec 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Trial of Neoadjuvant Zolbetuximab Plus Docetaxel, Oxaliplatin and S-1 Chemotherapy in Patients With Locally Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT06732856
- Acronym / sponsor ID
- NEO-CLAUD / AMC2402
- Conditions
- Stomach Neoplasm, Gastric (Stomach) Cancer
- Keywords
- NEO-ADJUVANT, ADJUVANT, distant metastasis limited to lymph node gastric cancer, unresectable locally advanced gastric cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 4 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Although the global incidence and mortality of gastric cancer has declined in recent decades, gastric cancer is the fifth most common cancer and the third leading cause of cancer-related death. Surgical resection is the main treatment for patients with localized gastric cancer. However, postoperative recurrences are common, and approximately 40% of patients experience recurrences 2 years after surgery.
Various adjuvant therapies have been studied over the past decades to improve the rate of postoperative recurrences. Perioperative chemotherapy and postoperative chemoradiotherapy or adjuvant chemotherapy has been shown to improve overall survival in patients with resectable gastric cancer. The preferred treatment strategy is chosen according to the expected locoregional control after surgery, and tends to vary depending on the geographical location.
Two large randomized, controlled, Phase 3 trials in East Asia investigated the efficacy of S-1 for 1 year or capecitabine and oxaliplatin (XELOX) for 6 months as adjuvant chemotherapy following D2 gastrectomy compared to D2 gastrectomy alone in patients with resectable gastric cancer. Both studies showed an apparent benefit of adjuvant chemotherapy versus surgery alone in survival, with 5-year overall survival rates of 70 to 80% in patients receiving adjuvant chemotherapy and 60 to 70% in patients receiving surgery alone. Based on these results, D2 gastrectomy with S-1 or XELOX as adjuvant chemotherapy is the treatment strategy generally selected for patients with resectable gastric cancer in East Asia. However, approximately 30 to 35% of patients experience disease recurrence despite the addition of adjuvant chemotherapy, suggesting that a better treatment strategy needs to be developed in this clinical setting.
One of the strategies for improving survival outcomes of locally advanced gastric cancer may be the introduction of neoadjuvant chemotherapy. Recently, the pivotal phase 3 PRODIGY and RESOLVE studies have demonstrated survival benefits of adding neoadjuvant chemotherapy to surgery followed by adjuvant chemotherapy over up-front surgery followed by adjuvant chemotherapy in Asian patients. Based on these results, neoadjuvant chemotherapy is considered one of the viable options for patients with locally advanced gastric cancer.
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.
< Primary objective(s)>
- RP2D (phase Ib part)
- Pathologic complete regression rate (pCR) (phase II part)
< Secondary objective(s)>
- Progression-free survival by RECIST v1.1
- Overall survival (OS)
- Overall response rate (ORR) during by RECIST v 1.1
- Disease control rate (DCR) by RECIST v 1.1
- Safety profiles by
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: zolbetuximab, Drug: Oxaliplatin, Drug: Docetaxel, Drug: S-1 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zolbetuximab1. 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. | Drug | Treatment |
| Oxaliplatin1. 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. | Drug | Treatment |
| Docetaxel1. 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. | Drug | Treatment |
| S-11. 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. | Drug | Treatment |
Primary outcome
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.(phase II part)
Time frame: 1 year
Evaluation of R0 resection rate.
Recommended phase 2 dose (RP2D) (phase Ib part)
Time frame: 1 year
Recommended phase 2 dose (RP2D) (phase Ib part)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Min-Hee Ryu, MD, PhD principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing zolbetuximab, Oxaliplatin and Docetaxel in people with Stomach Neoplasm and Gastric (Stomach) Cancer, run by Asan Medical Center at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min-Hee Ryu, MD,PhD (82-2-3010-5935, miniryu@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of R0 resection rate in patients who underwent prior chemotherapy as a clinical trial.(phase II part) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.