| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 |
|
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| 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 |
||||||||
| Condition ICMJE | Advanced Malignancies | ||||||||
| Intervention ICMJE | Drug: SHR-1501
Administered subcutaneously
|
||||||||
| Study Arms ICMJE |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| 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:
|
||||||||
| Sex/Gender ICMJE |
|
||||||||
| Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
|
||||||||
| 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 |
|
||||||||
| 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 |
|
||||||||
| 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 |
|||||||||