Actively Recruiting
A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2025-11-17
162
Participants Needed
1
Research Sites
111 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of SHR-3821 Injection in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation and written informed consent
- Age between 18 and 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
- Life expectancy of at least 3 months
- Pathologically confirmed advanced solid tumor
- Ability to provide fresh or archived tumor tissue
- At least one measurable lesion according to RECIST v1.1
- Adequate bone marrow and organ function
- Use of contraception during the trial
You will not qualify if you...
- History or symptoms of meningeal or central nervous system metastasis
- Uncontrolled tumor-related pain
- Uncontrolled pleural, pericardial, or abdominal effusion with symptoms
- Prior systemic antitumor therapy before the first dose
- Previous treatment with therapies similar to SHR-3821 before the first dose
- Systemic anticancer treatment within 4 weeks before study treatment
- Unresolved toxicities of grade 2 or higher from previous cancer therapy
- Current or past interstitial lung disease (ILD)
- Severe active digestive disease
- Previous or other existing malignancies
- History of severe allergic reactions to SHR-3821 or its ingredients
- Active hepatitis B or C
- Other conditions deemed inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
West China Hospital of Sichuan Hospital
Chengdu, Sichuan, China, 610000
Actively Recruiting
Research Team
B
Bin bai
CONTACT
H
Hao Shen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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