Actively Recruiting
A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients
Led by Suzhou Immunofoco Biotechnology Co., Ltd · Updated on 2025-10-23
150
Participants Needed
1
Research Sites
94 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
An open-label, randomized, comparative phase II study including patients with CLDN18.2-positive unresectable locally advanced gastric cancer. To evaluate the objective response rate (ORR) and progression-free survival (PFS) of IMC002 compared with investigator's choice of treatment (ICT) as third-line or later therapy in patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with positive CLDN18.2 expression.
CONDITIONS
Official Title
A Phase III Randomized Study in CLDN18.2-positive Unresectable Locally Advanced Gastric Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age at least 18 years old at randomization
- Histologically or cytologically confirmed inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma
- Have failed at least two prior lines of therapy with radiographic progression or intolerance to second-line treatment
- Positive CLDN18.2 expression in tumor tissue (≥40% tumor cells with intensity ≥2+)
- Expected survival period of at least 12 weeks
- At least one measurable target or evaluable lesion per RECIST 1.1 with lesion size ≤5 cm
- ECOG performance status of 0 or 1
- Adequate organ and bone marrow function as defined by specific laboratory criteria
- Previous anti-tumor therapy toxicities resolved to Grade 0-1 or acceptable levels
- Willingness to use effective contraceptive measures during and up to 12 months after treatment
- Signed informed consent
- Willing and able to comply with treatment and study requirements
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HIV, active hepatitis B or C, syphilis, Epstein-Barr virus, cytomegalovirus, HTLV, or recent COVID-19 infection
- Known HER2 positive expression
- Active or poorly controlled serious infections
- Uncontrolled pleural, pericardial effusion, or ascites
- Extensive or diffuse lung, liver, or bone metastases
- Blood oxygen saturation ≤95% without oxygen
- Serious pulmonary diseases limiting study participation
- Large or deep ulcers or tumor infiltration posing high bleeding or perforation risk
- Central nervous system diseases or uncontrolled metastases
- Unstable or poorly controlled heart disease or hypertension
- Recent significant cardiac events or abnormalities
- Coagulopathy or significant bleeding risk
- Recent use of systemic steroids above specified doses or immunosuppressive drugs
- Active autoimmune diseases or history with expected recurrence, with some exceptions
- Previous or concurrent malignancies except specific treated cancers
- Prior gene therapies including CAR-T or TCR-T
- Recent anti-tumor treatments within defined washout periods
- History of severe allergies like anaphylactic shock
- Severe mental disorders
- New uncontrolled arrhythmias or infections requiring intravenous antibiotics
- Participation in other interventional studies within 1 month before infusion
- Inability or unwillingness to comply with study protocol
- Recent live attenuated vaccine or planned during study
- Gastrointestinal obstruction or obstructive jaundice
- Other serious uncontrolled medical conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Chinese PLA General Hospital, Beijing
Beijing, China, 100853
Actively Recruiting
Research Team
J
Jianming Xu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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