Non-small Cell Lung Cancer (NSCLC)
Conditions
Brief summary
This is an open label, multi-center, multiple dose Phase IB/II study to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in subjects with NSCLC.
Interventions
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. 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 NSCLC. 6. Be able to provide fresh or archived tumour tissue. 7. At least one measurable lesion according to RECIST v1.1. 8. Adequate organ function. 9. Contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose.
Exclusion criteria
1. Meningeal metastasis history or clinical symptoms of central nervous system metastasis. 2. Previous or co-existing malignancies. 3. Spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded. 4. Uncontrollable tumor-related pain. 5. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to the initial dosing; Minor traumatic surgery within 7 days prior to the first dosing. 6. Received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment. 7. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy. 8. With poorly controlled or severe cardiovascular disease. 9. Active hepatitis B and hepatitis C. 10. Patients with a history of immunodeficiency. 11. Severe infection 30 days before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recommended phase II dose (RP2D) | Screening up to study completion, an average of 1 year. |
| Adverse events (AEs) | Screening up to study completion, an average of 1 year. |
| Objective response rate (ORR) | Screening up to study completion, an average of 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | Screening up to study completion, an average of 1 year. |
| Drug resistant antibody (ADA) to SHR-1826 | Screening up to study completion, an average of 1 year. |
| Disease control rate (DCR) | Screening up to study completion, an average of 1 year. |
| Blood concentration of free toxin | Screening up to study completion, an average of 1 year. |
| Blood concentration of SHR-1826 | Screening up to study completion, an average of 1 year. |
| Duration of response (DoR) | Screening up to study completion, an average of 1 year. |
| Progression-free survival (PFS) | Screening up to study completion, an average of 1 year. |
Countries
China
Contacts
Primary ContactYijun Jia
Backup ContactTingting Lei
Outcome results
None listed