Actively Recruiting
SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
Led by Shanghai Hengrui Pharmaceutical Co., Ltd. · Updated on 2025-12-31
924
Participants Needed
1
Research Sites
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study consists of two research phases: Phase Ib (includes dose escalation stage and efficacy expansion stage): To explore the safety, tolerability and initial efficacy of SHR-A1904 in the treatment of CLDN18.2-positive advanced solid tumors, and to determine the recommended dose and recommended population for the Phase III combination study. Phase III: A randomized, Open-Label, multicenter clinical study of SHR-A1904 combined with chemotherapy and immunotherapy Versus chemotherapy combined with immunotherapy for CLDN18.2-positive advanced solid tumors.
CONDITIONS
Official Title
SHR-A1904 Combinations in CLDN18.2-Positive Advanced Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years old (including boundary values)
- Volunteer to participate and sign informed consent
- ECOG performance status score of 0 or 1
- Expected survival of at least 3 months
- Pathologically confirmed locally advanced unresectable or metastatic solid tumors
- Positive CLDN18.2 expression in tumor tissue
- At least one measurable lesion meeting RECIST 1.1 criteria
- Adequate bone marrow and organ function
You will not qualify if you...
- Planning to receive any other antitumor therapy during this trial
- Received investigational drugs or treatments not on the market within 4 weeks prior to first administration
- Received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks before first administration
- Received palliative radiotherapy or local therapy within 2 weeks before first administration
- Had major surgery (other than diagnosis or biopsy) within 4 weeks prior to first administration or randomization
- HER2 expression positive in tumor tissue
- Previous anti-tumor therapy adverse reactions not recovered to grade 1 or less
- Peripheral sensory neuropathy grade 2 or higher
- Allergic reaction to study treatments or humanized monoclonal antibody products
- History or current meningeal metastasis or active brain metastases
- Presence of dysphagia or factors affecting use of oral medications
- Additional malignancy within 5 years prior to first administration or randomization
- Active or history of autoimmune disease
- Systemic corticosteroids or immunosuppressants use within 14 days prior to first administration or randomization
- History of clinically significant lung disease
- Serosal effusion grade 3 or higher
- Active infection requiring systemic treatment within 2 weeks prior to first administration or randomization
- History of immunodeficiency or positive HIV test; active hepatitis B or C
- Previous allogeneic hematopoietic stem cell or organ transplantation
- Severe cardiovascular or cerebrovascular diseases
- Gastrointestinal perforation or fistula within 6 months prior to first administration or randomization; active gastrointestinal bleeding within 3 months prior
- Other factors judged by investigator that could affect study results or cause study termination
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qi Shi
CONTACT
D
Di Zong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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