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
1 other identifier
interventional
107
1 country
1
Brief Summary
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2025
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2025
CompletedFirst Posted
Study publicly available on registry
December 10, 2025
CompletedStudy Start
First participant enrolled
December 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
January 15, 2026
January 1, 2026
1.4 years
November 27, 2025
January 13, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (19)
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.
- +14 more secondary outcomes
Study Arms (3)
Low-Dose Group
EXPERIMENTALMedium-Dose Group
EXPERIMENTALHigh-Dose Group
EXPERIMENTALInterventions
SHR-A1811 subcutaneous injection.
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2025
First Posted
December 10, 2025
Study Start
December 23, 2025
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
January 15, 2026
Record last verified: 2026-01