Clinical Trials/NCT07275242

NCT07275242

Recruiting

Phase 1

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

Suzhou Suncadia Biopharmaceuticals Co., Ltd.1 site in 1 country107 target enrollmentDecember 23, 2025

InterventionsSHR-A1811 Subcutaneous Injection SHR-A1811 for Injection

Overview

Phase: Phase 1
Intervention: SHR-A1811 Subcutaneous Injection
Conditions: Not specified
Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Enrollment: 107
Locations: 1
Primary Endpoint: Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)
Status: Recruiting
Last Updated: 3 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

December 23, 2025

End Date

December 1, 2027

Last Updated

3 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•≥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 Criteria

•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.

Arms & Interventions

Low-Dose Group

Intervention: SHR-A1811 Subcutaneous Injection

Low-Dose Group

Intervention: SHR-A1811 for Injection

Medium-Dose Group

Intervention: SHR-A1811 Subcutaneous Injection

Medium-Dose Group

Intervention: SHR-A1811 for Injection

High-Dose Group

Intervention: SHR-A1811 Subcutaneous Injection

High-Dose Group

Intervention: SHR-A1811 for Injection

Outcomes

Primary Outcomes

Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)

Time Frame: About 72 weeks.

The incidence and severity of Dose-Limiting Toxicities (DLTs)

Time Frame: About 72 weeks.

Adverse Events (AEs)

Time Frame: About 72 weeks.

Secondary Outcomes

Anti-SHR-A1811 antibodies (ADA)(About 72 weeks.)
Maximum concentration (Cmax)(About 72 weeks.)
Trough concentration (Cmin)(About 72 weeks.)
Objective Response Rate (ORR)(About 72 weeks.)
Apparent clearance (CL/F)(About 72 weeks.)
Maximum concentration at steady state (Css, max)(About 72 weeks.)
Time to maximum concentration (Tmax)(About 72 weeks.)
Elimination half-life (t1/2)(About 72 weeks.)
Mean residence time (MRT)(About 72 weeks.)
Apparent volume of distribution at steady state (Vss/F)(About 72 weeks.)
Area under the concentration-time curve at steady state (AUCss)(About 72 weeks.)
Accumulation ratio (Rac)(About 72 weeks.)
Duration of Response (DoR)(About 72 weeks.)
Disease Control Rate (DCR)(About 72 weeks.)
Overall Survival (OS)(About 72 weeks.)
Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t)(About 72 weeks.)
Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf)(About 72 weeks.)
Trough concentration at steady state (Css, min)(About 72 weeks.)
Progression-Free Survival (PFS)(About 72 weeks.)