Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07872722
PHASE2

Zolbetuximab, Durvalumab, and FLOT Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Sponsor: National Cancer Center, Japan

View on ClinicalTrials.gov

Summary

Claudin 18.2 (CLDN18.2) is a molecular target expressed in a subset of gastric and gastroesophageal junction (GEJ) adenocarcinomas. Zolbetuximab, a chimeric monoclonal antibody targeting CLDN18.2, has shown clinical benefit in combination with chemotherapy for CLDN18.2-positive unresectable advanced or recurrent gastric cancer, and in Japan, FLOT plus durvalumab is expected to become a standard perioperative treatment for locally advanced gastric/GEJ adenocarcinoma. This trial evaluates whether adding zolbetuximab to FLOT plus durvalumab further improves the pathological response of neoadjuvant chemotherapy in CLDN18.2-positive, locally advanced, resectable gastric or GEJ adenocarcinoma. This is a single-arm, open-label, multicenter, investigator-initiated phase II trial conducted at four sites in Japan. Eligible participants are adults (18 years or older) with previously untreated (no prior chemotherapy, radiotherapy, or immunotherapy), histologically confirmed gastric or GEJ adenocarcinoma classified as cT2-4 and/or cN+, M0 by the UICC/TNM Classification (8th edition), confirmed to be CLDN18.2-positive (moderate or greater membranous staining in 75% or more of tumor cells) by immunohistochemistry, with an ECOG performance status of 0 or 1. The primary endpoint is the histological complete response rate (Grade 3) on the surgical specimen, assessed by a central pathological review committee. Key secondary endpoints include the incidence of adverse events, the treatment completion rate through surgery, the dose intensity of neoadjuvant chemotherapy, the R0 resection rate, and the histological response rate (Grade 2 or higher).

Official title: Phase II Trial of Zolbetuximab, Durvalumab, and FLOT (5-FU, Leucovorin, Oxaliplatin, and Docetaxel) Combination Neoadjuvant Chemotherapy for CLDN18.2-Positive Gastric Cancer or Gastroesophageal Junction Adenocarcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2026-08-13

Completion Date

2030-03-31

Last Updated

2026-10-14

Healthy Volunteers

No

Interventions

DRUG

Zolbetuximab

Zolbetuximab 800 mg/m\^2 (loading dose; reduced to 600 mg/m\^2 if not tolerated) is administered intravenously on Cycle 1 Day 1, followed by 400 mg/m\^2 on Day 1 of Cycles 2-4 (2-week cycles).

DRUG

Durvalumab

Durvalumab 1,500 mg (or 20 mg/kg for participants weighing 30 kg or less) is administered intravenously on Cycle 1 Day 2 and Cycle 3 Day 1 or 2 only (2 administrations in total).

DRUG

FLOT (5-fluorouracil, leucovorin, oxaliplatin, and docetaxel)

FLOT (5-fluorouracil 2,600 mg/m\^2, leucovorin 100 mg/m\^2, oxaliplatin 85 mg/m\^2, and docetaxel 50 mg/m\^2) is administered intravenously every 2 weeks for 4 cycles, in combination with zolbetuximab and durvalumab, as neoadjuvant treatment prior to surgery.

Locations (4)

Saitama Cancer Center

Saitama, Japan

National Cancer Center Hospital

Tokyo, Japan

The Cancer Institute Hospital of JFCR

Tokyo, Japan

Kanagawa Cancer Center

Yokohama, Japan