Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002
NCT ID: NCT06832982
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
66 participants
INTERVENTIONAL
2025-02-13
2026-09-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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dose escalation and dose extension
42patients for dose escalation ,total 6dose group(30 mg、90 mg、270 mg、600 mg、1000 mg、1500 mg），24 patients for dose extension
FS-8002 injection
Q3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first
Interventions
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FS-8002 injection
Q3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first
Eligibility Criteria
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Inclusion Criteria
2. According to the evaluation criteria of RECIST V1.1 or RANO 2.0 (GBM only), at least one measurable lesion is required: the selected target lesion has not been treated previously locally, or the selected target lesion is located in the previous local treatment area, but is determined to be disease progression through imaging investigation;
3. The subject has sufficient organ and bone marrow function;
Exclusion Criteria
2. Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug;
3. Have used any systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever is shorter) before the first administration of the study drug, including systemic chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy (small molecule targeted drugs are within 2 weeks before the first administration), systemic immunomodulators (including but not limited to IFN, IL-2 and tumor necrosis factor \[TNF\]). Received Chinese herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before the first administration;For patients with GBM: less than 12 weeks from the end of previous radiotherapy (unless the progressing lesion is located outside the high-dose zone or 80% isodose line irradiation field, or there is pathological evidence), less than 24 days from the last TMZ treatment, or less than 6 weeks from the last carmustine treatment;
4. Have used or are currently using aspirin (≥ 325 mg/day) or other anti-platelet aggregation drugs such as clopidogrel, dipyridamole, ticlopidine, and cilostazole, or full-dose anticoagulants or thrombolytics within 2 weeks prior to the first administration of the study drug;
5. Those who have received major surgical treatment or significant traumatic injury within 4 weeks before the first administration of the study drug, or those who have a history of fistula, gastrointestinal perforation, or tumor invasion of large blood vessels within 6 months before the first administration; or those who have intestinal obstruction during the screening period;
18 Years
ALL
No
Sponsors
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Shanghai Pushi Medical Science Co. Ltd
INDUSTRY
Responsible Party
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Locations
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Beijing Tiantan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Cancer hospital
Fujian, Fuzhou, China
The First Affiliated Hospital of Zhejiang Medical University
Zhejiang, Hangzhou, China
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, China
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)
Shandong, Jinan, China
Meizhou People's Hospital
Guangdong, Meizhou, China
The First Affiliated Hospital of China Medical University
Shenyang, Shenyang, China
Hebei General Hospital
Hebei, Shijiazhuang, China
West China Hospital Sichuan University
Chengdu, Sichuan, China
Union Hospital, Tongji Medical College
Hubei, Wuhan, China
Hubei Cancer Hospital
Hubei, Wuhan, China
Countries
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Central Contacts
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Facility Contacts
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Wenbin Li, Doctor
Role: primary
Lin Shen, Doctor
Role: primary
Rongbo Lin, Master
Role: primary
Jianzhen Shan, Doctor
Role: primary
Tongsen Zheng, Doctor
Role: primary
Shuqin Ni, Doctor
Role: primary
Xiwen Huang, Bachelor
Role: primary
Funan Liu, Doctor
Role: primary
Peng Li, Doctor
Role: primary
Feng Wang, Doctor
Role: primary
Hongli Liu, Doctor
Role: primary
Xinjun Liang, Doctor
Role: primary
Other Identifiers
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FS-8002-001-CN
Identifier Type: -
Identifier Source: org_study_id