- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03474289
Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
March 15, 2018 updated by: Jiangsu HengRui Medicine Co., Ltd.
A Phase 1 Study to Evaluate the Safety and Tolerability of SHR-1316 in Subjects With Advanced Tumors
The purpose of this study is to access the safety and tolerability of the study drug known as SHR-1316 in metastatic/advanced malignancies
Study Overview
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 Type
Interventional
Enrollment (Anticipated)
134
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gang Chen, PhD
- Phone Number: +86 (021)50118422
- Email: chen_gang@shhrp.com
Study Contact Backup
- Name: Ying Tian
- Email: tianying@shhrp.com
Study Locations
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-
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Shanghai, China
- Recruiting
- Fudan University Shanghai Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female ≥18 years of age
- Subjects with confirmed advanced malignancies (histologically or cytologically)
- ECOG Performance status of 0 or 1
- Adequate organ functions
- Life expectancy ≥12 weeks;
Exclusion Criteria:
- Subjects with active autoimmune disease.
- Systemic cytotoxic chemotherapy, biological therapy, or major surgery within 4 weeks of the first dose of trial treatment
- Previous received PD-1 or PD-L1 therapy
- Known Active central nervous system (CNS) metastases
- Known Clinically significant cardiovascular condition
- Active infection or an unexplained fever >38.5°C
- History of immunodeficiency
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Escalation
SHR-1316 administrated intravenously(IV) at protocol defined dose levels
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Monotherapy
Other Names:
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EXPERIMENTAL: Expansion
SHR-1316 administrated IV in advanced solid tumors and selected tumor type
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Monotherapy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: at the end of cycle one(each cycle is 21 days)
|
incidence and severity of treatment-related adverse events
|
at the end of cycle one(each cycle is 21 days)
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Dose-limiting toxicities (DLTs)
Time Frame: at the end of cycle one(each cycle is 21 days)
|
Number of participants with DLTs
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at the end of cycle one(each cycle is 21 days)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2018
Primary Completion (ANTICIPATED)
January 30, 2019
Study Completion (ANTICIPATED)
October 31, 2019
Study Registration Dates
First Submitted
March 11, 2018
First Submitted That Met QC Criteria
March 15, 2018
First Posted (ACTUAL)
March 22, 2018
Study Record Updates
Last Update Posted (ACTUAL)
March 22, 2018
Last Update Submitted That Met QC Criteria
March 15, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- SHR-1316-I-101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Clinical Trials on SHR-1316
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Jiangsu HengRui Medicine Co., Ltd.CompletedAdvanced MalignanciesAustralia, China
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Jiangsu HengRui Medicine Co., Ltd.Not yet recruiting
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Atridia Pty Ltd.Active, not recruitingAdvanced Malignant TumorsAustralia
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Atridia Pty Ltd.CompletedAdvanced Solid TumorsAustralia
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Jiangsu HengRui Medicine Co., Ltd.RecruitingAdvanced Non-small Cell Lung CancerChina
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Shandong Suncadia Medicine Co., Ltd.Not yet recruiting
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Jiangsu HengRui Medicine Co., Ltd.CompletedSmall Cell Lung CancerChina
-
Suzhou Suncadia Biopharmaceuticals Co., Ltd.Enrolling by invitationAdvanced Malignant TumorsChina
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Wuhan Union Hospital, ChinaNot yet recruitingLimited-stage Small Cell Lung Cancer, LS-SCLC
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Tongji HospitalRecruiting