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

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

Study Overview

• Status: Terminated
• Conditions: Advanced Solid Tumor
• Intervention / Treatment: Drug: SHR-1702; Drug: Camrelizumab

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Chinese PLA General Hospital
      • Contact: Shunchang Jiao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2019
• Primary Completion (Actual): June 21, 2021
• Study Completion (Actual): June 21, 2021

Study Registration Dates

• First Submitted: February 17, 2019
• First Submitted That Met QC Criteria: March 10, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: SHR-1702-I-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No