Solid Tumors
Conditions
Brief summary
This is an open-label, three-part study to evaluate the safety and efficacy of SHR-4375 for injection in subjects with solid tumors.
Interventions
DRUGSHR-4375
SHR-4375 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 No maximum
Healthy volunteers
No
Inclusion criteria
1. The subjects voluntarily joined the study and signed the ICF. 2. Measurable disease, as defined by RECIST v1.1. 3. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1. 4. Life expectancy ≥ 12 weeks. 5. Subjects with cytologically or histologically confirmed advanced solid tumors who have failed or are intolerant to standard therapy, have no standard therapy, or refuse standard therapy.
Exclusion criteria
1. Symptomatic, untreated or active central nervous system metastases. 2. With any active autoimmune disease or history of autoimmune disease. 3. Patients with active hepatitis B or hepatitis C. 4. Severe infections prior to initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) | From Day 1 to 90 days after last dose. |
| Dose limiting toxicity (DLT) | From Day 1 to 12 months. |
| Maximal tolerable dose (MTD) | From Day 1 to 12 months. |
| Recommended phase 2 dose (RP2D) | From Day 1 to 12 months. |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) | From Day 1 to 12 months. |
| Overall survival (OS) | From Day 1 to 12 months. |
| Objective response rate (ORR) | From Day 1 to 12 months. |
| Disease control rate (DCR) | From Day 1 to 12 months. |
| Duration of response (DOR) | From Day 1 to 12 months. |
Countries
China
Contacts
Primary ContactYuanchao Wang
Outcome results
None listed