Actively Recruiting
Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002
Led by Shanghai Pushi Medical Science Co. Ltd · Updated on 2026-04-09
66
Participants Needed
10
Research Sites
155 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
this is a single-arm, open phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacokinetics, and preliminary efficacy of FS-8002 and combination therapy in patients with advanced solid tumors
CONDITIONS
Official Title
Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with advanced solid tumors confirmed by histology or cytology who have failed or cannot tolerate standard treatments, or lack a standard regimen. GBM patients must have primary GBM with first recurrence after radiochemotherapy.
- At least one measurable lesion per RECIST V1.1 or RANO 2.0 (GBM only), untreated or progressing in previous local treatment area.
- Sufficient organ and bone marrow function.
You will not qualify if you...
- Previous treatment with TGF-β inhibitors, bevacizumab, or other VEGF/VEGFR-targeted drugs (for GBM patients).
- Use of any experimental drug within 4 weeks before first study drug administration.
- Systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever shorter) before first study drug dose, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy, or immunomodulators.
- Use of Chinese herbal or proprietary anti-tumor medicines within 2 weeks before study drug.
- For GBM patients: less than 12 weeks from end of radiotherapy, less than 24 days from last TMZ treatment, or less than 6 weeks from last carmustine treatment.
- Use of aspirin ≥325 mg/day or other anti-platelet or full-dose anticoagulant drugs within 2 weeks before study drug.
- Major surgery or significant trauma within 4 weeks before study drug.
- History of fistula, gastrointestinal perforation, tumor invasion of large blood vessels within 6 months before study drug.
- Intestinal obstruction during screening period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
2
Fujian Cancer hospital
Fujian, Fuzhou, China, 350013
Actively Recruiting
3
The First Affiliated Hospital of Zhejiang Medical University
Zhejiang, Hangzhou, China, 310003
Actively Recruiting
4
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, China, 150081
Actively Recruiting
5
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)
Shandong, Jinan, China, 250117
Actively Recruiting
6
Meizhou People's Hospital
Guangdong, Meizhou, China, 514031
Actively Recruiting
7
The First Affiliated Hospital of China Medical University
Shenyang, Shenyang, China, 110001
Actively Recruiting
8
Hebei General Hospital
Hebei, Shijiazhuang, China, 050010
Actively Recruiting
9
Union Hospital, Tongji Medical College
Hubei, Wuhan, China, 430022
Actively Recruiting
10
Hubei Cancer Hospital
Hubei, Wuhan, China, 430079
Actively Recruiting
Research Team
X
Xiaojun Wang, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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