Actively Recruiting
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
Led by Jiangsu HengRui Medicine Co., Ltd. · Updated on 2026-01-02
83
Participants Needed
28
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study (dose escalation/expansion) is being conducted to assess the safety and tolerability of SHR-A1904 in subjects with advanced solid tumors, and to determine maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D), to assess preliminary efficacy of SHR-A1904, pharmacokinetic (PK) profile and immunogenicity of SHR-A1904 in subjects with advanced solid tumors.
CONDITIONS
Official Title
A TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF SHR-A1904 IN SUBJECTS WITH ADVANCED SOLID TUMORS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form.
- Age over 18 years.
- ECOG performance status of 0 or 1.
- Life expectancy of at least 3 months.
- Pathologically diagnosed advanced relapsed or refractory solid tumors (gastric, gastroesophageal junction, or pancreatic cancer) intolerant to standard treatments or with no effective available options.
- Positive Claudin 18.2 expression (>=50% of tumor cells with 2+ or 3+ staining) confirmed by immunohistochemistry.
- At least one measurable lesion as defined by RECIST v1.1.
- Adequate organ and bone marrow function within 7 days before treatment, including specified blood counts, liver and kidney function, coagulation times, heart function (QTcF ≤450 msec), and left ventricular ejection fraction ≥50%.
- Women of childbearing potential must have a negative pregnancy test within 3 days before the first dose and agree to use effective contraception during and after the study period.
You will not qualify if you...
- Planned use of other anti-tumor treatments during the study.
- Participation in prior investigational studies or anticancer treatment without recovery from side effects.
- Major surgery within 4 weeks before first dose.
- Recent use of strong CYP3A4, CYP2D6, P-gp, or BCRP inhibitors or inducers.
- Prior total gastrectomy (dose-escalation part only).
- Unresolved adverse events from previous treatments above Grade 1 (except alopecia and some tolerable Grade 2 toxicities).
- Allergy to SHR-A1904 components or humanized monoclonal antibodies.
- Known brain metastases unless stable and over 1 month post definitive therapy.
- Second primary cancer except certain treated cancers with no disease for 3 years.
- Severe cardiac conditions (NYHA Class III-IV, unstable angina, recent myocardial infarction).
- History or suspicion of significant lung diseases.
- Serious infections requiring intravenous antimicrobial treatment.
- Hepatitis B or C infection requiring treatment.
- History of immunodeficiency or organ transplant.
- Serious uncontrolled diseases that could affect safety or study completion as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 28 locations
1
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States, 33140
Active, Not Recruiting
2
Comprehensive Hematology Oncology
St. Petersburg, Florida, United States, 33709
Terminated
3
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
Active, Not Recruiting
4
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Terminated
5
Rhode Island Hospital
Providence, Rhode Island, United States, 02905
Terminated
6
Prisma Health
Greenville, South Carolina, United States, 29605
Active, Not Recruiting
7
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Active, Not Recruiting
8
Central Coast Local Health District
Gosford, New South Wales, Australia, 2250
Completed
9
Sydney South West Private Hospital
Liverpool, New South Wales, Australia
Actively Recruiting
10
Scientia Clinical Research Ltd
Randwick, New South Wales, Australia, 2031
Actively Recruiting
11
Genesis Care North Shore
St Leonards, New South Wales, Australia, 2065
Completed
12
Macquarie University
Sydney, New South Wales, Australia, 2109
Actively Recruiting
13
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
14
Gold Coast Private Hospital
Southport, Queensland, Australia, 4215
Not Yet Recruiting
15
Peninsula and South Eastern Haematology & Oncology Group (PASO)
Frankston, Victoria, Australia, 3199
Actively Recruiting
16
One Clinical Research (OCR)
Nedlands, Western Australia, Australia, 8000
Actively Recruiting
17
National Institute of Oncology, Arensia Research Clinic
Chisinau, Moldova, MD-2000
Active, Not Recruiting
18
Dong-A University Hospital
Busan, South Korea, 49201
Actively Recruiting
19
Chungbuk National University Hospital
Cheongju-si, South Korea, 28644
Actively Recruiting
20
Ajou University Hospital
Gyeonggi-do, South Korea, 16499
Actively Recruiting
21
Seoul National University Bundang Hospital
Seongnam, South Korea, KS009
Actively Recruiting
22
CHA Bundang Medical Centre
Seongnam-si, South Korea, 13496
Actively Recruiting
23
Korea University Anam Hospital
Seoul, South Korea, 02841
Actively Recruiting
24
Korea University Guro Hospital
Seoul, South Korea, 02841
Actively Recruiting
25
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Actively Recruiting
26
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
27
Samsung Medical Center
Seoul, South Korea, 06531
Actively Recruiting
28
Seoul National University Hospital
Seoul, South Korea, 3080
Actively Recruiting
Research Team
B
Bo Chao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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