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

Hengrui Medicine

Status and phase: Terminated; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: SHR-1702; Drug: Camrelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03871855

SHR-1702-I-101

Details and patient eligibility

About

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

Enrollment: 8 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 4 patient groups

A:SHR-1702 Dose Escalation

Experimental group

Description:

SHR-1702 given intravenously (IV).

Treatment:

Drug: SHR-1702

B:SHR-1702 Dose Expansion

Experimental group

Description:

SHR-1702 given intravenously (IV).

Treatment:

Drug: SHR-1702

C:SHR-1702 and Camrelizumab Dose Escalation

Experimental group

Description:

SHR-1702 and Camrelizumab given intravenously (IV).

Treatment:

Drug: SHR-1702

Drug: Camrelizumab

D:SHR-1702 and Camrelizumab Dose Expansion

Experimental group

Description:

SHR-1702 and Camrelizumab given intravenously (IV).

Treatment:

Drug: SHR-1702

Drug: Camrelizumab