Clinical trial NCT03871855: A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
Official title: A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-03-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Number of Participants with DLTs
timeFrame: Approximately 28 Days
Secondary outcomes:
measure: ORR: Percentage of Participants With a CR or PR
timeFrame: Approximately 2 years
measure: Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events.
timeFrame: Dose Escalation Part -- Approximately 2 years
measure: Immunogenicity as assessed by the presence of anti-drug antibodies
timeFrame: Approximately 2 years
measure: Pharmacodynamic profile as assessed by receptor occupancy
timeFrame: Approximately 2 years
measure: PK Parameter: Maximum Concentration (Cmax)
timeFrame: Approximately 2 years
measure: PK Parameter: AUC, 0 to infinity
timeFrame: Approximately 2 years
measure: PK Parameter: Clearance (CL)
timeFrame: Approximately 2 years
measure: PK Parameter: Cmin at steady state (Cmin,ss)
timeFrame: Approximately 2 years
measure: PK Parameter: Cmax at steady state (Cmax, ss)
timeFrame: Approximately 2 years
measure: PK Parameter: terminal half-life (t1/2)
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: