A Phase 1 interventional study of SHR-1210 in Advanced Solid Tumors, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment
This is an open-label, multiple centers, non-randomized, dose escalation phase I trial to evaluate safety and tolerability of SHR-1210 in patients with advanced solid tumors The primary objective is to assess safety and tolerability of SHR-1210 and identify recommended phase II doses of SHR-1210 in patients with advanced solid tumors
9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.
This study's enrollment of 126 is above the median of 50 across 7,250 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1)Patients who have received treatment for brain or meningeal metastasis can be included if they are clinically stable (MRI) for at least 2 months and have discontinued systemic hormonal therapy (> 10 mg/day prednisone or equivalent) for more than 2 weeks; 2)Non-small cell lung cancer patients with brain metastasis, except those requiring local radiotherapy, can be enrolled into 200 mg fixed dose group (refer to Study Design and Schedule of Activities sections).
Biological: SHR-1210
Biological: SHR-1210
Biological: SHR-1210
Biological: SHR-1210
A fully human monoclonal immunoglobulin (IgG4 subtype)
Number of Participants Experiencing Adverse Events (AEs)
The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version \[v\] 4.03 2010).
Time frame: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 7 months)
Number of Participants Experiencing Severe AEs (SAEs)
The safety assessment documented in this clinical study included any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an investigational product, which were monitored per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE version \[v\] 4.03 2010).
Time frame: From the time the participants signed the informed consent to 90 days after the final dose (Up to 3 years and 7 months)
Maximum Observed Serum Concentration (Cmax) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Area Under the Serum Concentration-time Curve to infinite time (AUC 0-inf) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Area Under the Serum Concentration-time Curve from dosing to the time of the last measured concentration (AUC 0-last) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Time to Maximum Concentration (Tmax) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Half-life (T½) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Clearance (Cl) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Volume of distribution (Vd) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Mean Residence Time (MRT) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
C(ss, Max) of SHR-1210 after Multiple Dosing
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
C(ss, Min) of SHR-1210 after Multiple Dosing
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Accumulation ratio based on Cmax (Rac, Cmax) for SHR-1210
Time frame: PK blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
PD-1 receptor occupancy (RO) for SHR-1210
Receptor occupancy (RO) assays are designed to quantify the binding of therapeutics to their targets on the cell surface and are frequently used to generate pharmacodynamic (PD) biomarker data in nonclinical and clinical studies of biopharmaceuticals.
Time frame: PD blood samples are collected multiple times on Cycle 1 (each cycle is 28 days) Day1, Day 8, Day 15, Day 22, Cycle 2 Day 1, Since Cycle 2, every 3 cycle Day 1, and the day disease progression (Up to 3 years and 7 months).
Number of Participants with Anti-drug Antibodies (ADAs) for SHR-1210
ADAs: Immunogenicity was summarized by the number and percentage of participants who developed detectable treatment-emergent ADAs.
Time frame: Blood samples for ADAs analysis are collected on Cycle 1 (each cycle is 28 days) Day1 to the end of treatment (Up to 3 years and 7 months).
Objective Response Rate (ORR)
ORR was defined as the percentage of participants in the study whose best overall response was either complete response (CR) or partial response (PR) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Time frame: Up to 3 years and 7 months
Disease Control Rate (DCR)
DCR was defined as the percentage of participants in the study whose best overall response was either CR, PR or stable disease (SD) as assessed by investigators based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1.
Time frame: Up to 3 years and 7 months
Progression-free survival (PFS)
PFS was defined as the time from the date of first study dose to disease progression or death whichever occurs first. Participants without an event (no disease progression or death) were censored at the date of "last tumor assessment". Participants with no baseline or post-baseline tumor assessments were censored at Day 1. PFS was based on RECIST v 1.1 and the results of Investigator evaluations. Median PFS was calculated by Kaplan-Meier method.
Time frame: Up to 3 years and 7 months
Plan to share: Undecided
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Jiangsu HengRui Medicine Co., Ltd.