Actively Recruiting
A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-01-09
300
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is an open-label, multicenter Phase I/II clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of SHR-1681 for injection in patients with advanced solid tumors.
CONDITIONS
Official Title
A Phase I/II Clinical Study of SHR-1681 for Injection in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must voluntarily agree to participate in the trial and sign a written informed consent form
- Subjects must have histologically or cytologically confirmed unresectable locally advanced or metastatic solid tumors that are relapsed, refractory to standard treatment, lack standard treatment, or cannot currently use standard treatment
- Must have at least one measurable tumor lesion according to RECIST v1.1
- ECOG performance status must be 0 or 1
- Life expectancy must be at least 3 months
- Must have adequate bone marrow and organ function
You will not qualify if you...
- Subjects with active central nervous system metastases or meningeal metastases
- History of serious cardiovascular or cerebrovascular diseases
- History of interstitial pneumonitis or suspected interstitial pneumonitis on screening imaging
- Severe infection within 4 weeks before the first dose
- Ongoing or previous anti-tumor therapies within 4 weeks before the first dose of study drug
- Adverse reactions from previous anti-tumor treatments have not improved to Grade 1 or below per NCI-CTCAE v5.0
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Dongfang Hospital
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
F
Fei Qiu
CONTACT
T
Ting Lu, M.M
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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