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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Drug: SHR-A1811 Subcutaneous Injection; Drug: SHR-A1811 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07275242

SHR-A1811(sc)-101

Details and patient eligibility

About

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

Enrollment: 107 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

Low-Dose Group

Experimental group

Treatment:

Drug: SHR-A1811 for Injection

Drug: SHR-A1811 Subcutaneous Injection

Medium-Dose Group

Experimental group

Treatment:

Drug: SHR-A1811 for Injection

Drug: SHR-A1811 Subcutaneous Injection

High-Dose Group

Experimental group

Treatment:

Drug: SHR-A1811 for Injection

Drug: SHR-A1811 Subcutaneous Injection