Advanced Solid Tumors
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 advanced solid tumors.
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 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 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. Previously received antiboy-coupled drug therapy with topoisomerase I inhibitor toxin; Previously received EGFR/c-Met double antibody; 6. Received systemic antitumor therapy before the first dose; 7. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; 8. For the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment; 9. Received Other investigational drugs treatments 4 weeks prior to the initiation of the study treatment; 10. Unresolved CTCAE 5.0\>grade 2 toxicities from previous anticancer therapy; 11. A history of interstitial pneumonia/non-infectious pneumonia; 12. Accompanied by uncontrolled pleural effusion and pericardial effusion; Moderate or severe ascites with clinical symptoms; 13. Study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing; 14. With poorly controlled or severe cardiovascular disease; 15. Active hepatitis B, hepatitis C; 16. Patients with a history of immunodeficiency; 17. Severe infection 30 days before the first dose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RP2D (Phase 1) | Screening up to study completion, an average of 1 year. |
| AE (Phase 1) | Screening up to study completion, an average of 1 year. |
| Objective response rate (ORR) (Phase 2) | Screening up to study completion, an average of 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Objective response rate (ORR) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Disease control rate (DCR) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Duration of response (DoR) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Progression-free survival (PFS) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Overall survival (OS) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Drug Resistant Antibody (ADA) (Phase 1) | Screening up to study completion, an average of 1 year. |
| Blood concentration of SHR-1826 (Phase 1) | Screening up to study completion, an average of 1 year. |
| Blood concentration of free toxin SHR169265 (Phase 1) | Screening up to study completion, an average of 1 year. |
| Disease control rate (DCR) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Duration of response (DoR) (Phase 2) | Screening up to study completion, an average of 1 year. |
| Overall survival (OS) (Phase 2) | Screening up to study completion, an average of 1 year. |
| AE (Phase 2) | Screening up to study completion, an average of 1 year. |
Countries
China
Contacts
Primary ContactRongfu Mao, MD
Backup ContactHao Shen, BS
Outcome results
None listed