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Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03474289
Recruitment Status : Unknown
Verified March 2018 by Jiangsu HengRui Medicine Co., Ltd..
Recruitment status was:  Recruiting
First Posted : March 22, 2018
Last Update Posted : March 22, 2018
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Study Description
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Brief Summary:
The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies

Condition or disease Intervention/treatment Phase
Tumor Drug: SHR-1316 Phase 1

Detailed Description:
This is an open-label, non-randomized, dose escalation/expansion phase I study, SHR-1316 is a humanized IgG4 monoclonal antibody that binds specifically to human PD-L1.The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : October 31, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: Escalation
SHR-1316 administrated intravenously(IV) at protocol defined dose levels
 Drug: SHR-1316
Monotherapy
Other Name: HTI-1088
Experimental: Expansion
SHR-1316 administrated IV in advanced solid tumors and selected tumor type
 Drug: SHR-1316
Monotherapy
Other Name: HTI-1088


Outcome Measures
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Primary Outcome Measures :
  1. Adverse Events [ Time Frame: at the end of cycle one(each cycle is 21 days) ]
    incidence and severity of treatment-related adverse events

  2. Dose-limiting toxicities (DLTs) [ Time Frame: at the end of cycle one(each cycle is 21 days) ]
    Number of participants with DLTs


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥18 years of age
  2. Subjects with confirmed advanced malignancies (histologically or cytologically)
  3. ECOG Performance status of 0 or 1
  4. Adequate organ functions
  5. Life expectancy ≥12 weeks;

Exclusion Criteria:

  1. Subjects with active autoimmune disease.
  2. Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
  3. Previous received PD-1 or PD-L1 therapy
  4. Known Active central nervous system (CNS) metastases
  5. Known Clinically significant cardiovascular condition
  6. Active infection or an unexplained fever >38.5°C
  7. History of immunodeficiency
Contacts and Locations
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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): NCT03474289


Contacts
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Contact: Gang Chen, PhD +86 (021)50118422 chen_gang@shhrp.com
Contact: Ying Tian tianying@shhrp.com

Locations
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China
Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Xichun Hu       xchu2009@hotmail.com   
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Investigators
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Principal Investigator: Xichun Hu Fudan University
More Information
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT03474289    
Other Study ID Numbers: SHR-1316-I-101
First Posted: March 22, 2018    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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