Actively Recruiting
An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811 Subcutaneous Injection Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-01-15
107
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the pharmacokinetics, safety, tolerability, and effectiveness of SHR-A1811 subcutaneous injection in patients with solid tumors. This phase 1, open-label study aims to understand how the drug behaves in the body and its impact on tumor response. The study is sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd., and involves adult patients with confirmed solid tumors. Participants will receive SHR-A1811 through subcutaneous injection in one of three dose groups: low, medium, or high dose. This non-randomized study observes patients over approximately 72 weeks, focusing on drug levels in the blood and adverse effects. The study does not use placebo or blinding methods. Throughout the study, patients will undergo assessments including blood tests to measure drug concentration and immune response, evaluation of tumor size using RECIST criteria, and monitoring for side effects and dose-limiting toxicities. Researchers will track survival outcomes and disease control rates. Participants will be followed closely for safety and treatment response during the entire study period.
CONDITIONS
Brief Title
A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Confirmed solid tumor diagnosis by histology or cytology
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable tumor lesion according to RECIST v1.1 criteria
- Adequate kidney and liver function
- Voluntary participation with signed informed consent
You will not qualify if you...
- History of any other cancers in the past 5 years, except cured cervical carcinoma in situ or melanoma skin cancer
- Major surgery, radiotherapy, or chemotherapy within 4 weeks before starting study medication
- History of immunodeficiency
- Significant heart diseases
- Known or suspected interstitial lung disease
- Known bleeding or clotting disorders
- Active hepatitis or liver cirrhosis
- Allergic history to any study drug components
- History of neurological or psychiatric disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to about 72 weeks
Participants receive subcutaneous injections of SHR-A1811 to evaluate pharmacokinetics, safety, tolerability, and efficacy.
Regular visits for dosing and assessments during treatment
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Actively Recruiting
Research Team
Y
Yue Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
3
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