Solid Tumor
Conditions
Brief summary
The study is being conducted to evaluate the pharmacokinetics , safety, tolerability and efficacy in patients with solid tumor.
Interventions
DRUGSHR-A1811 Subcutaneous Injection
SHR-A1811 subcutaneous injection.
SHR-A1811 for injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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. |
| Time to maximum concentration (Tmax) | 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. |
| Trough concentration at steady state (Css, min) | About 72 weeks. |
| Maximum concentration (Cmax) | About 72 weeks. |
| Trough concentration (Cmin) | About 72 weeks. |
Countries
China
Contacts
Primary ContactYue Zhang
Outcome results
None listed