Actively Recruiting
An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-04-13
240
Participants Needed
1
Research Sites
187 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, multi-center, dose-escalation/dose-expansion/efficacy expansion phase I clinical study to evaluate the tolerability, safety, PK, and immunogenicity of SHR-1826 in patients with advanced malignant solid tumors, and to preliminatively observe its antitumor efficacy. The whole study was divided into three stages: dose increment, dose extension and therapeutic effect extension.
CONDITIONS
Official Title
An Open Phase I Clinical Trial of SHR-1826 for Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide written informed consent
- Age between 18 and 75 years, male or female
- ECOG performance status of 0 or 1
- Diagnosed with advanced or metastatic solid tumors confirmed by histopathology
- Disease not responding to or intolerant of standard treatments, or no effective standard options available
- Have at least one measurable lesion per RECIST v1.1 criteria
- Expected survival of at least 3 months
- Good vital organ function
- Use of contraception during the study period
You will not qualify if you...
- Untreated or active central nervous system tumor metastasis or history of meningeal metastasis
- Previous or co-existing malignant tumors
- Untreated spinal cord compression
- Uncontrolled tumor-related pain
- Received systemic antitumor therapy within 4 weeks before starting study treatment; for prior small molecule targeted therapy, at least 5 half-lives must have passed
- Previous antibody-coupled drug therapy
- Major surgery other than diagnosis or biopsy within 28 days prior to dosing; minor surgery within 7 days prior to dosing
- Chest radiation exceeding 30Gy non-radical within 28 days or within 24 weeks, or palliative radiation of 30Gy or less within 14 days prior to dosing; prior radioisotope therapy must meet a 5 half-life interval
- Participation in another clinical study within 4 weeks or within 5 half-lives of investigational drug
- Adverse events from prior antitumor therapy not recovered to Grade 1 or less per CTCAE v5.0
- Severe lung diseases affecting pulmonary toxicity detection or management; autoimmune, connective tissue, or inflammatory lung diseases; prior total lung resection
- Pleural effusion, ascites, or pericardial effusion needing intervention within 2 weeks prior to first dose
- Active autoimmune disease, immunodeficiency, or history of organ transplantation
- Poorly controlled or severe cardiovascular disease
- Known bleeding or thrombotic disorders with recent significant events
- Untreated active hepatitis
- Severe infection within 30 days or active pulmonary tuberculosis within 1 year or untreated past tuberculosis
- Live attenuated vaccine within 30 days prior to first dose
- Pregnant, breastfeeding, or planning pregnancy during study
- Known allergy to SHR-1826 or its components
- Other serious physical or mental illnesses or lab abnormalities increasing risk or interfering with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yijun Jia
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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