Recruiting NCT07275242
A Clinical Study of SHR-A1811(sc) Subcutaneous Injection in Patients With Solid Tumor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811 Subcutaneous Injection, SHR-A1811 for Injection.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
Interventions
- Drug SHR-A1811 Subcutaneous Injection
SHR-A1811 subcutaneous injection. - Drug SHR-A1811 for Injection
SHR-A1811 for injection.
Primary outcome measures
- 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 outcome measures (12)
- Time to maximum concentration (Tmax) [Time frame: About 72 weeks.]
- Maximum concentration (Cmax) [Time frame: About 72 weeks.]
- Trough concentration (Cmin) [Time frame: About 72 weeks.]
- Area under the concentration-time curve from time zero to the time of the last measurable concentration (AUC0-t) [Time frame: About 72 weeks.]
- Area under the concentration-time curve from time zero extrapolated to infinity (AUCinf) [Time frame: About 72 weeks.]
- Elimination half-life (t1/2) [Time frame: About 72 weeks.]
- Mean residence time (MRT) [Time frame: About 72 weeks.]
- Apparent clearance (CL/F) [Time frame: About 72 weeks.]
- Apparent volume of distribution at steady state (Vss/F) [Time frame: About 72 weeks.]
- Area under the concentration-time curve at steady state (AUCss) [Time frame: About 72 weeks.]
- Maximum concentration at steady state (Css, max) [Time frame: About 72 weeks.]
- Trough concentration at steady state (Css, min) [Time frame: About 72 weeks.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital, Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT07275242 · SHR-A1811(sc)-101