Condition or disease | Intervention/treatment | Phase |
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Advanced Malignancies | Drug: SHR-1501 Drug: SHR-1316 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 104 participants |
Allocation: | Non-Randomized |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination With SHR-1316 in Patients With Advanced Malignancies |
Actual Study Start Date : | February 14, 2020 |
Estimated Primary Completion Date : | June 2022 |
Estimated Study Completion Date : | June 2023 |
Arm | Intervention/treatment |
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Experimental: SHR-1501 and SHR-1316 dose escalation
SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.
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Drug: SHR-1501
Administered subcutaneously
Drug: SHR-1316 Administered intravenously
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Experimental: SHR-1501 and SHR-1316 dose expansion
SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously.
|
Drug: SHR-1501
Administered subcutaneously
Drug: SHR-1316 Administered intravenously
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Experimental: SHR-1501 and SHR-1316 Indication expansion
SHR-1501 given subcutaneously with a recommended dose. SHR-1316 given intravenously.
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Drug: SHR-1501
Administered subcutaneously
Drug: SHR-1316 Administered intravenously
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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 |
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 |
Australia, New South Wales | |
Sydney Southwest Private Hospital | Recruiting |
Liverpool, New South Wales, Australia, 2170 | |
Contact: Aflah Roohullah 87389744 | |
Scientia Clinical Research | Recruiting |
Randwick, New South Wales, Australia, 2031 | |
Contact: Charlotte Lemech | |
Australia, Queensland | |
Icon Cancer Centre South Brisbane | Not yet recruiting |
South Brisbane, Queensland, Australia, 4101 | |
Contact: Jermaine Coward 37374500 | |
John Flynn Private Hospital | Not yet recruiting |
Tugun, Queensland, Australia, 4224 | |
Contact: Andrea Tazbirkova 55314811 | |
China, Guangdong | |
Guangdong General Hospital & Guangdong Academy of Medical Sciences | Not yet recruiting |
Guangzhou, Guangdong, China, 510080 | |
Contact: Yilong Wu, MD 020-83827812 syylwu@live.cn |
Study Director: | Yilong Wu, MD | Guangdong General Hospital & Guangdong Academy of Medical Sciences |
Tracking Information | |||||||||
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First Submitted Date ICMJE | May 9, 2019 | ||||||||
First Posted Date ICMJE | June 24, 2019 | ||||||||
Last Update Posted Date | July 22, 2020 | ||||||||
Actual Study Start Date ICMJE | February 14, 2020 | ||||||||
Estimated Primary Completion Date | June 2022 (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 Combined With SHR-1316 in Patients With Advanced Tumors | ||||||||
Official Title ICMJE | A Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetics and Efficacy of SHR-1501 in Combination With SHR-1316 in Patients With Advanced Malignancies | ||||||||
Brief Summary | The purpose of this study is to evaluate the safety and tolerability of SHR-1501 in combination with SHR-1316 in patients with advanced malignancies and to provide a recommended dose (RP2D) for subsequent clinical studies. | ||||||||
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 |
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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 |
104 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | June 2023 | ||||||||
Estimated Primary Completion Date | June 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria: • All Patients All patients must meet all the following criteria to be eligible to participate:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Australia, China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03995472 | ||||||||
Other Study ID Numbers ICMJE | SHR-1501-I-101 | ||||||||
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 | February 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |