Actively Recruiting
A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors
Led by Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Updated on 2026-05-01
198
Participants Needed
1
Research Sites
103 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open label, multi-center, Phase Ib/II study to evaluate the safety, tolerability and efficacy of SHR-4375 injection in combination with other antitumor therapies in patients with advanced solid tumors.
CONDITIONS
Official Title
A Study of SHR-4375 Injection in Combination With Other Antitumor Therapies in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with written informed consent
- Age between 18 and 75 years, any gender
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Life expectancy of at least 12 weeks
- Advanced solid tumors confirmed by cytology or histology, with no standard treatment options remaining
- Ability to provide fresh or archived tumor tissue
- At least one measurable lesion based on RECIST v1.1 criteria
- Adequate bone marrow and organ function
- Use of contraception during the trial and negative pregnancy test within 7 days before first dose for women of childbearing potential
You will not qualify if you...
- Histopathological types containing neuroendocrine carcinoma or sarcoma components
- Received chemotherapy, immunotherapy, targeted therapy, anti-tumor traditional Chinese medicine, or other clinical trial drugs within 4 weeks before first dose
- Received palliative radiotherapy within 2 weeks before first dose
- Use of live attenuated vaccines as specified before or expected during treatment
- Major surgeries (other than diagnosis or biopsy) within 28 days before first dose
- Previous antibody-drug conjugate therapy containing topoisomerase I inhibitors
- Participation in other clinical studies or medication use less than 4 weeks after prior study
- Presence of other active malignant tumors within 3 years or simultaneously
- Symptomatic or active central nervous system tumor metastasis
- Uncontrolled tumor-related pain
- Severe infections within 30 days before first dose
- History of interstitial or non-infectious pneumonia requiring hormone therapy
- Unresolved adverse events from prior anti-tumor treatment above CTCAE v5.0 level 1
- Active hepatitis B or C
- Significant bleeding symptoms or risk within 1 month before first dose
- Moderate to severe symptomatic ascites, uncontrolled or moderate to excessive pleural or pericardial effusion
- Uncontrolled mental illness or conditions affecting study completion including substance abuse or detention
- Any other investigator-assessed risks or factors interfering with study participation or results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Y
Yunpeng Jing
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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