RecruitingPhase 1NCT07275242

A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor

An Open-Label, Multi-site Phase I Clinical Study of SHR-A1811(sc) Subcutaneous Injection: Evaluating Pharmacokinetics, Safety, Tolerability, and Efficacy in Patients With Solid Tumor

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Enrollment

107 participants

Start Date

Dec 23, 2025

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

Summary

The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

≥18 years of age;
Solid Tumor confirmed by histology or cytology;
ECOG score is 0 or 1;
An expected survival of ≥ 12 weeks;
At least one measurable lesion according to RECIST v1.1 criteria;
Have adequate renal and hepatic function;
Patients voluntarily joined the study and signed informed consent.

Exclusion Criteria9

With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer;
Patients have major surgical procedures or radiotherapy / chemotherapy within 4 weeks before the first medication;
History of immunodeficiency;
Clinically significant cardiovascular diseases;
Known or suspected interstitial lung disease;
Known hereditary or acquired bleeding thrombotic tendency;
Active hepatitis and liver cirrhosis;
Known allergic history of the drug components of this protocol;
History of neurological or psychiatric disorders.