- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04414150
A Trial of SHR-1802 in Patients With Failure of Standard Treatment for Advanced Malignant Tumours
October 25, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.
Tolerability, Safety and Pharmacokinetic Characteristics of SHR-1802 in Patients With Advanced Malignancy: a Phase I Clinical Study
This is the first study to test SHR-1802 in humans.
The primary purpose of this study is to see if SHR-1802 is safe and tolerable for patients with locally advanced/unresectable or metastatic malignancies that are refractory to available therapy or for which no standard therapy is available.
Study Overview
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tianjin
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Tianjin, Tianjin, China, 300060
- Tianjin Medical University Cancer Institute and Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Voluntary participation and written informed consent;
- Aged 18-75 years (inclusive), males and females;
- Patient must have histologically or clinically confirmed advanced and/or metastatic malignancies for which failure of standard treatment or lack of effective standard treatment;
- At least one measurable lesion according to RECIST v1.1;
- ECOG score of 0-1;
- Expected survival ≥ 12 weeks;
- Adequate bone marrow reserve and organ function were confirmed by baseline examination
- For female patients of childbearing potential or male patients with partners of childbearing potential who are not sterilized by surgical operations, they are required to use a medically approved contraceptive measure during the study treatment period and within 3 months after the end of the study treatment; For female patients of childbearing potential who are not sterilized by surgical operations, they must have a negative serum HCG test result within 72 h prior to study enrollment; and they must not be in the lactation period;
Exclusion Criteria:
- The presence of any active, known, or suspected autoimmune disease. Type 1 diabetes, which was admitted to receive stable dose of insulin, hypothyroidism, which required only hormone replacement therapy, skin disease with no need to systemic treatment and no acute exacerbation within 1 year before the screening period;
- Subjects who had received systemic treatment with corticosteroids or other immunosuppressive agents within 28 days prior to initial administration.
- Known and untreated central nervous system (CNS) or leptomeningeal metastases;
- Uncontrolled pleural effusion,or ascites requiring recurrent drainage procedures;
- Uncontrolled cardiac diseases or symptoms;
- Known hereditary or acquired bleeding and thrombotic tendencies;
- Patients who have previously received chemotherapy, radiotherapy or surgery which ended within 4 weeks prior to the start of this study; oral molecular targeted therapy with < 5 drug half-lives from the first study dose; or patients with AEs caused by previous treatment (except for alopecia) that have not returned to CTCAE Grade ≤ 1;
- Known active infection,;
- Congenital and acquired immune deficiency;
- HBsAg-positive and HBV DNA > 2000 IU/mL(or 104 copies/mL); HCV RNA copies > ULN;
- Patients with other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of the patients.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SHR-1802
|
This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dose limiting toxicity
Time Frame: Days 1-21
|
Days 1-21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients with adverse events
Time Frame: from the first drug administration to within 90 days for the last SHR-1802 dose
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from the first drug administration to within 90 days for the last SHR-1802 dose
|
|
Rates of dose suspension, dose reduction and dose discontinuation caused by investigational drug related adverse events
Time Frame: At pre-defined intervals from initial dose up to 24 months
|
At pre-defined intervals from initial dose up to 24 months
|
|
ORR
Time Frame: At pre-defined intervals from initial dose up to 24 months
|
At pre-defined intervals from initial dose up to 24 months
|
|
DOR
Time Frame: At pre-defined intervals from initial dose up to 24 months
|
At pre-defined intervals from initial dose up to 24 months
|
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DCR
Time Frame: At pre-defined intervals from initial dose up to 24 months
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At pre-defined intervals from initial dose up to 24 months
|
|
PFS
Time Frame: At pre-defined intervals from initial dose up to 24 months
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At pre-defined intervals from initial dose up to 24 months
|
|
Maximum Concentration (Cmax) of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
|
Time of Maximum Concentration (Tmax) of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
|
Area Under the Curve (AUC) of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
|
Terminal Half-Life (T1/2) of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
|
Clearance (CL) of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
|
Volume of Distribution at Steady State (Vss) of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
|
Evaluation of the immunogenicity of SHR-1802
Time Frame: At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
Serum sampling to assess the potential for anti-drug antibody (ADA) formation.
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At pre-defined intervals from initial dose through final study visit (up to 24 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 17, 2020
Primary Completion (ACTUAL)
January 13, 2022
Study Completion (ACTUAL)
March 15, 2022
Study Registration Dates
First Submitted
May 25, 2020
First Submitted That Met QC Criteria
May 29, 2020
First Posted (ACTUAL)
June 4, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHR-1802-I-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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