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

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

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Drug: SHR-A1811 for Injection; Drug: SHR-A1811 Subcutaneous Injection

• Study Type: Interventional
• Enrollment (Estimated): 107
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yue Zhang; Phone Number: +86-0518-82342973; Email: yue.zhang@hengrui.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
      • Principal Investigator: Herui Yao
      • Principal Investigator: Erwei Song
      • Contact: Erwei Song; Phone Number: +86-020-81332507; Email: songew@mail.sysu.edu.cn
      • Contact: Herui Yao; Phone Number: +86-020-81332507; Email: yaoherui@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-Dose Group	Drug: SHR-A1811 for Injection; SHR-A1811 for injection.; Drug: SHR-A1811 Subcutaneous Injection; SHR-A1811 subcutaneous injection.
Experimental: Medium-Dose Group	Drug: SHR-A1811 for Injection; SHR-A1811 for injection.; Drug: SHR-A1811 Subcutaneous Injection; SHR-A1811 subcutaneous injection.
Experimental: High-Dose Group	Drug: SHR-A1811 for Injection; SHR-A1811 for injection.; Drug: SHR-A1811 Subcutaneous Injection; SHR-A1811 subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area under the curve from time zero to 21 days (AUC0-21d) of SHR-A1811(sc)	About 72 weeks.
The incidence and severity of Dose-Limiting Toxicities (DLTs)	About 72 weeks.
Adverse Events (AEs)	About 72 weeks.

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to maximum concentration (Tmax)	About 72 weeks.
Maximum concentration (Cmax)	About 72 weeks.
Trough concentration (Cmin)	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.
Elimination half-life (t1/2)	About 72 weeks.
Mean residence time (MRT)	About 72 weeks.
Apparent clearance (CL/F)	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.
Maximum concentration at steady state (Css, max)	About 72 weeks.
Trough concentration at steady state (Css, min)	About 72 weeks.
Accumulation ratio (Rac)	About 72 weeks.
Anti-SHR-A1811 antibodies (ADA)	About 72 weeks.
Objective Response Rate (ORR)	About 72 weeks.
Duration of Response (DoR)	About 72 weeks.
Disease Control Rate (DCR)	About 72 weeks.
Progression-Free Survival (PFS)	About 72 weeks.
Overall Survival (OS)	About 72 weeks.

Collaborators and Investigators

• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: November 27, 2025
• First Posted (Estimated): December 10, 2025

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Drug Administration Routes; Drug Therapy; Injections
• Other Study ID Numbers: SHR-A1811(sc)-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No