Status:
TERMINATED
A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Advanced Solid Tumor
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03871855
Start Date
April 28 2019
End Date
June 21 2021
Last Update
June 5 2023
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China