Advanced Solid Tumors
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SHR-3792 injection monotherapy for patients with advanced solid tumors, and to explore the reasonable dosage of SHR-3792 injection monotherapy for patients with advanced solid tumors.
Interventions
DRUGSHR-3792 Injection
SHR-3792 injection.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects with ability to understand and voluntarily agree to participate by giving written informed consent form for the study. 2. Patients with unresectable recurrent or metastatic solid tumors. 3. There is at least one lesion that could be measured. 4. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 5. Adequate organ functions as defined. 6. Life expectancy ≥ 3 months.
Exclusion criteria
1. Patients with known active central nervous system (CNS) metastases. 2. Subjects with other malignancy in five years before the first dose. 3. Patients with tumor-related pain that cannot be controlled as determined. 4. Patients with serious cardiovascular and cerebrovascular diseases. 5. Uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion. 6. Patients with severe infections. 7. History of immunodeficiency. 8. History of autoimmune diseases. 9. Active infection. 10. Pregnant or nursing women. 11. Known history of serious allergic reactions to the investigational product or its main ingredients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum tolerated dose (MTD) | From the first dose of study medication up to 21 days. |
| Recommended phase Ⅱ dose (RP2D) | From the first dose of study medication up to 21 days. |
| Incidence of dose limited toxicity (DLT) | From the first dose of study medication up to 21 days. |
| Adverse events (AEs) | Up to 24 weeks. |
| Serious adverse events (SAEs) | Up to 24 weeks. |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to 6 months. |
Countries
China
Contacts
Primary ContactFangfang Peng
Outcome results
None listed