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Trial Title:
A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
NCT ID:
NCT06618651
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
To evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-3821 injection
in subjects with advanced solid tumors.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-3821 injection
Description:
SHR-3821 injection
Arm group label:
SHR-3821 injection
Summary:
This is an open label, multi-center, multiple dose Phase I study to evaluate the safety,
tolerability, pharmacokinetics and efficacy of SHR-3821 injection in subjects with
advanced solid tumors.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntary participation and written informed consent.
2. 18-75 years older, no gender limitation.
3. Eastern Cooperative Oncology Group (ECOG) score: 0-1.
4. With a life expectancy ≥ 3 months.
5. Pathologically diagnosed advanced solid tumor.
6. Be able to provide fresh or archived tumour tissue.
7. At least one measurable lesion according to RECIST v1.1.
8. Adequate bone marrow reserve and organ function.
9. Contraception is required during the trial.
Exclusion Criteria:
1. Meningeal metastasis history or clinical symptoms of central nervous system
metastasis.
2. Uncontrollable tumor-related pain.
3. Uncontrolled pleural effusion, pericardial effusion, or abdominal effusion with
clinical symptoms.
4. Received systemic antitumor therapy before the first dose.
5. Treated with similar target therapy as SHR-3821 before the first dose.
6. Received systemic anticancer treatments 4 weeks prior to the initiation of the study
treatment.
7. Unresolved CTCAE 5.0>=grade 2 toxicities from previous anticancer therapy.
8. Current or History of ILD.
9. Active severe digestive disease.
10. Previous or co-existing malignancies.
11. History of severe hypersensitivity reactions to either the drug substances or
inactive ingredients of SHR-3821.
12. Active hepatitis B or active hepatitis C.
13. Other inappropriate situation considered by the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan Hospital
Address:
City:
Chengdu
Zip:
610000
Country:
China
Contact:
Last name:
Jiankun Hu
Start date:
November 15, 2024
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06618651
