Condition or disease | Intervention/treatment | Phase |
---|---|---|
Advanced Malignancies | Drug: SHR-1501 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 48 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Study on Tolerance, Safety and Pharmacokinetics of SHR-1501 in Patients With Advanced Malignancies. |
Actual Study Start Date : | October 30, 2019 |
Estimated Primary Completion Date : | December 2020 |
Estimated Study Completion Date : | December 2021 |
Arm | Intervention/treatment |
---|---|
Experimental: SHR-1501 dose escalation
SHR-1501 given subcutaneously
|
Drug: SHR-1501
Administered subcutaneously
|
Experimental: SHR-1501 dose expansion
SHR-1501 given subcutaneously
|
Drug: SHR-1501
Administered subcutaneously
|
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All Patients All patients must meet all the following criteria to be eligible to participate:
Exclusion Criteria:
Contact: Jianjun Zou, MD | 021-68868570 | zoujianjun@hrglobe.cn | |
Contact: Wei Shi, MD | 021-68868570 | shiwei@hrglobe.cn |
China | |
Cancer hospital, Chinese academy of medical sciences | Recruiting |
Beijing, China, 100021 | |
Contact: Jing Huang, MD 010-67781331 huangjingwg@163.com |
Study Director: | Jing Huang, MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
Tracking Information | |||||||||
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First Submitted Date ICMJE | July 14, 2019 | ||||||||
First Posted Date ICMJE | July 19, 2019 | ||||||||
Last Update Posted Date | July 22, 2020 | ||||||||
Actual Study Start Date ICMJE | October 30, 2019 | ||||||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | A Study of SHR-1501 in Patients With Advanced Tumors | ||||||||
Official Title ICMJE | A Phase I Study on Tolerance, Safety and Pharmacokinetics of SHR-1501 in Patients With Advanced Malignancies. | ||||||||
Brief Summary | The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in patients with advanced malignancies . | ||||||||
Detailed Description | Not Provided | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 1 | ||||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Sequential Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Advanced Malignancies | ||||||||
Intervention ICMJE | Drug: SHR-1501
Administered subcutaneously
|
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
48 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2021 | ||||||||
Estimated Primary Completion Date | December 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04025957 | ||||||||
Other Study ID Numbers ICMJE | SHR-1501-I-102 | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Responsible Party | Jiangsu HengRui Medicine Co., Ltd. | ||||||||
Study Sponsor ICMJE | Jiangsu HengRui Medicine Co., Ltd. | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Jiangsu HengRui Medicine Co., Ltd. | ||||||||
Verification Date | July 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |