Malignant Tumors of Adults
Conditions
Brief summary
The study is being conducted to evaluate the safety and tolerability of SHR-4506 Injection in patients with malignant tumors and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Interventions
DRUGSHR-4506 Injection
SHR-4506 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. Age ≥18 years, any gender. 2. ECOG performance status 0-1. 3. Histologically or cytologically confirmed malignant tumor patients who have failed standard therapy, or are intolerant to standard therapy, or have no standard treatment available. 4. Adequate organ function. 5. Voluntary participation in this clinical trial, with full understanding of study procedures and ability to provide written informed consent. 6. Expected survival ≥12 weeks. 7. Patients in the dose-expansion phase must have measurable lesions. 8. Agreement to use contraception from the time of signing the informed consent to at least 60 days after the last dose of the investigational drug.
Exclusion criteria
1. Prior treatment with the same class of investigational drug. 2. Confirmed or suspected central nervous system (CNS) tumor involvement. 3. Uncontrolled tumor-related pain. 4. Active autoimmune disease, history of immunodeficiency (including primary or secondary, e.g., HIV infection), or autoimmune disorders requiring systemic therapy. 5. Clinically significant cardiovascular disease history. 6. Known hypersensitivity to any component of the investigational drug. 7. Major surgery or significant trauma within 4 weeks prior to the first dose of the investigational drug; diagnostic or superficial surgery within 7 days before the first dose; or planned major surgery during the study period. 8. Adverse events from prior therapy have not recovered to ≤ CTCAE Grade 1. 9. Severe infection within 4 weeks before the first dose, or active infection within 2 weeks. 10. History of cerebrovascular accident within 6 months before the first dose of the investigational drug. 11. Patients with other active malignancies within 2 years prior to the first dose or concurrent malignancies. 12. Patients with any other condition judged by the investigator that makes the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limited Toxicities (DLTs) | Up to 21 days. |
| Maximum Tolerated Dose (MTD) | Up to 21 days. |
| Incidence and severity of adverse events (AEs) | Up to 90 days after the last dose. |
| Incidence and severity of serious adverse events (SAEs) | Up to 90 days after the last dose. |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) assessed by the investigator | Up to 3 years. |
| Objective tumor response duration (DoR) | Up to 3 years. |
| Disease control rate (DCR) | Up to 3 years. |
| Progression free survival (PFS) | Up to 3 years. |
| Overall survival (OS) | Up to 3 years. |
Countries
China
Contacts
CONTACTJie Shen
Outcome results
None listed