Advanced Solid Tumors
Conditions
Brief summary
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
Interventions
DRUGSHR-3821 injection
SHR-3821 injection
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with advanced solid tumors.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntary participation and written informed consent. 2. 18-75 years older, no gender limitation. 3. Eastern Cooperative Oncology Group (ECOG) score: 0-1. 4. With a life expectancy ≥ 3 months. 5. Pathologically diagnosed advanced solid tumor. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate bone marrow reserve and organ function. 9. Contraception is required during the trial.
Exclusion criteria
1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Uncontrollable tumor-related pain. 3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with clinical symptoms. 4. Received systemic antitumor therapy before the first dose. 5. Treated with similar target therapy as SHR-3821 before the first dose. 6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study treatment. 7. Unresolved CTCAE 5.0\>=grade 2 toxicities from previous anticancer therapy. 8. Current or History of ILD. 9. Active severe digestive disease. 10. Previous or co-existing malignancies. 11. History of severe hypersensitivity reactions to either the drug substances or inactive ingredients of SHR-3821. 12. Active hepatitis B or active hepatitis C. 13. Other inappropriate situation considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT | 3 weeks |
| AE | Screening up to study completion, an average of 1 year |
| MTD | 3 weeks |
| RP2D | Screening up to study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Drug Resistant Antibody (ADA) to SHR-3821 | Screening up to study completion, an average of 1 year |
| Objective response rate (ORR) | Screening up to study completion, an average of 1 year |
| Blood concentration of SHR-3821 after single and continuous administration | Screening up to study completion, an average of 1 year |
| Progression-free survival (PFS) | Screening up to study completion, an average of 1 year |
| Overall survival (OS) | Screening up to study completion, an average of 1 year |
| Disease control rate (DCR) | Screening up to study completion, an average of 1 year |
| PK parameters of SHR-3821 after single and continuous administration: Tmax | Screening up to study completion, an average of 1 year |
| PK parameters of SHR-3821 after single and continuous administration: Cmax | Screening up to study completion, an average of 1 year |
| PK parameters of SHR-3821 after single and continuous administration: AUC0-t | Screening up to study completion, an average of 1 year |
Countries
China
Contacts
Primary ContactBin bai
Backup ContactHao Shen
Outcome results
None listed