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

Advanced Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03871855
• Other study ID #: SHR-1702-I-101
• Status: Terminated
• Phase: Phase 1
• Start date: April 28, 2019
• Est. completion date: June 21, 2021

Study information

• Verified date: June 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 21, 2021
• Est. primary completion date: June 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• SHR-1702
Administered IV
• Camrelizumab
Administered IV

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with DLTs		Approximately 28 Days
Secondary	ORR: Percentage of Participants With a CR or PR		Approximately 2 years
Secondary	Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events.		Dose Escalation Part -- Approximately 2 years
Secondary	Immunogenicity as assessed by the presence of anti-drug antibodies		Approximately 2 years
Secondary	Pharmacodynamic profile as assessed by receptor occupancy		Approximately 2 years
Secondary	PK Parameter: Maximum Concentration (Cmax)		Approximately 2 years
Secondary	PK Parameter: AUC, 0 to infinity		Approximately 2 years
Secondary	PK Parameter: Clearance (CL)		Approximately 2 years
Secondary	PK Parameter: Cmin at steady state (Cmin,ss)		Approximately 2 years
Secondary	PK Parameter: Cmax at steady state (Cmax, ss)		Approximately 2 years
Secondary	PK Parameter: terminal half-life (t1/2)		Approximately 2 years