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

RECRUITINGPhase 1Sponsored by Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Actively Recruiting
PhasePhase 1
SponsorSuzhou Suncadia Biopharmaceuticals Co., Ltd.
Started2025-12-23
Est. completion2027-06
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

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

Exclusion Criteria:

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

Conditions2

CancerSolid Tumor

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