A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
- Registration Number
- NCT03871855
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description B:SHR-1702 Dose Expansion SHR-1702 SHR-1702 given intravenously (IV). C:SHR-1702 and Camrelizumab Dose Escalation SHR-1702 SHR-1702 and Camrelizumab given intravenously (IV). D:SHR-1702 and Camrelizumab Dose Expansion SHR-1702 SHR-1702 and Camrelizumab given intravenously (IV). A:SHR-1702 Dose Escalation SHR-1702 SHR-1702 given intravenously (IV). C:SHR-1702 and Camrelizumab Dose Escalation Camrelizumab SHR-1702 and Camrelizumab given intravenously (IV). D:SHR-1702 and Camrelizumab Dose Expansion Camrelizumab SHR-1702 and Camrelizumab given intravenously (IV).
- Primary Outcome Measures
Name Time Method Number of Participants with DLTs Approximately 28 Days
- Secondary Outcome Measures
Name Time Method Immunogenicity as assessed by the presence of anti-drug antibodies Approximately 2 years Pharmacodynamic profile as assessed by receptor occupancy Approximately 2 years Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events. Dose Escalation Part -- Approximately 2 years PK Parameter: Maximum Concentration (Cmax) Approximately 2 years PK Parameter: AUC, 0 to infinity Approximately 2 years PK Parameter: terminal half-life (t1/2) 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
Trial Locations
- Locations (1)
Chinese PLA General Hospital
🇨🇳Beijing, Beijing, China