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

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ClinicalTrials.gov Identifier: NCT03871855
Recruitment Status : Not yet recruiting
First Posted : March 12, 2019
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : April 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

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




Primary Outcome Measures :
  1. Number of Participants with DLTs [ Time Frame: Approximately 28 Days ]

Secondary Outcome Measures :
  1. ORR: Percentage of Participants With a CR or PR [ Time Frame: Approximately 2 years ]
  2. Safety and tolerability of SHR -1702 using Common Terminology Criteria for Adverse Events. [ Time Frame: Dose Escalation Part -- Approximately 2 years ]
  3. Immunogenicity as assessed by the presence of anti-drug antibodies [ Time Frame: Approximately 2 years ]
  4. Pharmacodynamic profile as assessed by receptor occupancy [ Time Frame: Approximately 2 years ]
  5. PK Parameter: Maximum Concentration (Cmax) [ Time Frame: Approximately 2 years ]
  6. PK Parameter: AUC, 0 to infinity [ Time Frame: Approximately 2 years ]
  7. PK Parameter: Clearance (CL) [ Time Frame: Approximately 2 years ]
  8. PK Parameter: Cmin at steady state (Cmin,ss) [ Time Frame: Approximately 2 years ]
  9. PK Parameter: Cmax at steady state (Cmax, ss) [ Time Frame: Approximately 2 years ]
  10. PK Parameter: terminal half-life (t1/2) [ Time Frame: Approximately 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03871855


Contacts
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Contact: Jianjun Zou, MD 021-68868570 zoujianjun@hrglobe.cn

Locations
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China, Beijing
Chinese PLA General Hospital Not yet recruiting
Beijing, Beijing, China
Contact: Shunchang Jiao         
Contact: Yi Hu         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Study Director: Jianjun Zou, Jiangsu HengRui Medicine Co., Ltd.

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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03871855     History of Changes
Other Study ID Numbers: SHR-1702-I-101
First Posted: March 12, 2019    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No