A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety of SHR-1702 monotherapy or in combination with Camrelizumab among advanced solid tumor subjects.

Official Title
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A Study of SHR-1702 Alone or With Camrelizumab in Participants With Advanced Relapsed/Refractory Solid Tumors

Conditions
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Advanced Solid Tumor

Intervention / Treatment
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* Drug: SHR-1702
* Drug: Camrelizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A:SHR-1702 Dose Escalation<br>SHR-1702 given intravenously (IV). | Drug: SHR-1702<br>* Administered IV<br>|
| Experimental: B:SHR-1702 Dose Expansion<br>SHR-1702 given intravenously (IV). | Drug: SHR-1702<br>* Administered IV<br>|
| Experimental: C:SHR-1702 and Camrelizumab Dose Escalation<br>SHR-1702 and Camrelizumab given intravenously (IV). | Drug: SHR-1702<br>* Administered IV<br>Drug: Camrelizumab<br>* Administered IV<br>|
| Experimental: D:SHR-1702 and Camrelizumab Dose Expansion<br>SHR-1702 and Camrelizumab given intravenously (IV). | Drug: SHR-1702<br>* Administered IV<br>Drug: Camrelizumab<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with DLTs |  | Approximately 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR: Percentage of Participants With a CR or PR |  | Approximately 2 years | 
| 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 | 
| PK Parameter: AUC, 0 to infinity |  | 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 |