Advanced Solid Tumor
Conditions
Brief summary
The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.
Interventions
DRUGSHR-1702
Administered IV
DRUGCamrelizumab
Administered IV
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed advanced relapsed/refractory solid tumors * Must have a performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) scale * Have an estimated life expectancy of 12 weeks, in judgement of the investigator； * Must have at least 1 measurable lesion assessable using standard techniques by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) * Adequate hematologic and organ function * Signed inform consent form
Exclusion criteria
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. * Significant cardiovascular disease * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring * History of autoimmune disease. * Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid are permitted in the absence of active autoimmune disease. * Positive test result for human immunodeficiency virus (HIV); Active hepatitis B or hepatitis C * Active or untreated central nervous system (CNS) metastases * Active infection within 2 weeks * History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins * Prior allogeneic bone marrow transplantation or solid organ transplant * History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with DLTs | Approximately 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events. | Dose Escalation Part -- Approximately 2 years |
| Immunogenicity as assessed by the presence of anti-drug antibodies | Approximately 2 years |
| Pharmacodynamic profile as assessed by receptor occupancy | Approximately 2 years |
| PK Parameter: Maximum Concentration (Cmax) | Approximately 2 years |
| ORR: Percentage of Participants With a CR or PR | Approximately 2 years |
| PK Parameter: Clearance (CL) | Approximately 2 years |
| PK Parameter: Cmin at steady state (Cmin,ss) | Approximately 2 years |
| PK Parameter: Cmax at steady state (Cmax, ss) | Approximately 2 years |
| PK Parameter: terminal half-life (t1/2) | Approximately 2 years |
| PK Parameter: AUC, 0 to infinity | Approximately 2 years |
Countries
China
Outcome results
None listed