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

Sponsor

Jiangsu HengRui Medicine Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT03871855

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor	Drug: SHR-1702 Drug: Camrelizumab	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A:SHR-1702 Dose Escalation SHR-1702 given intravenously (IV).	Drug: SHR-1702 Administered IV
Experimental: B:SHR-1702 Dose Expansion SHR-1702 given intravenously (IV).	Drug: SHR-1702 Administered IV
Experimental: C:SHR-1702 and Camrelizumab Dose Escalation SHR-1702 and Camrelizumab given intravenously (IV).	Drug: SHR-1702 Administered IV Drug: Camrelizumab Administered IV
Experimental: D:SHR-1702 and Camrelizumab Dose Expansion SHR-1702 and Camrelizumab given intravenously (IV).	Drug: SHR-1702 Administered IV Drug: Camrelizumab Administered IV

Outcome Measures

Primary Outcome Measures

Number of Participants with DLTs [Approximately 28 Days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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 weeeks
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

Investigators

Study Director: Jianjun Zou,, Jiangsu HengRui Medicine Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangsu HengRui Medicine Co., Ltd.

ClinicalTrials.gov Identifier:

NCT03871855

Other Study ID Numbers:

SHR-1702-I-101

First Posted:

Mar 12, 2019

Last Update Posted:

Mar 12, 2019

Last Verified:

Dec 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of Mar 12, 2019