| Condition or disease | Intervention/treatment | Phase | 
|---|---|---|
| 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 | 
|---|---|
| Experimental: SHR-1501 and SHR-1316 dose escalation SHR-1501 given subcutaneously with different doses. SHR-1316 given intravenously. | Drug: SHR-1501 Administered subcutaneously Drug: SHR-1316 Administered intravenously | 
| 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 | 
| Experimental: SHR-1501 and SHR-1316 Indication expansion SHR-1501 given subcutaneously with a recommended dose. SHR-1316 given intravenously. | Drug: SHR-1501 Administered subcutaneously Drug: SHR-1316 Administered intravenously | 
| 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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| 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 | 
 | ||||||||
| 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 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 | ||||||||
| Condition ICMJE | Advanced Malignancies | ||||||||
| Intervention ICMJE | 
 | ||||||||
| 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 | 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: 
 | ||||||||
| Sex/Gender ICMJE | 
 | ||||||||
| Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE | 
 | ||||||||
| 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 | 
 | ||||||||
| 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 | February 2020 | ||||||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||||