Clinical trial NCT06832982: Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002
Official title: A Single-arm, Open Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Pushi Medical Science Co. Ltd
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: this is a single-arm, open phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, pharmacokinetics, and preliminary efficacy of FS-8002 in patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

1. Patients with advanced solid tumors confirmed by histology or cytology who have failed or become intolerant to previous standard treatments, or who do not have a standard treatment regimen；
2. At least one measurable lesion according to the RECIST V1.1 assessment criteria ；
3. The subject has sufficient organ and bone marrow function；

Exclusion Criteria:

1. Patients who have previously received TGF-β inhibitor therapy；
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;
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;

Primary outcomes:
measure: MTD
timeFrame: 1.5years
measure: RP2D
timeFrame: 1.5years
measure: DLT
timeFrame: 1 years
measure: AE
timeFrame: 2years
measure: SAE
timeFrame: 2years
Secondary outcomes:
measure: peak concentration (Cmax)
timeFrame: 1.5years
measure: peak time (Tmax)
timeFrame: 1.5years
measure: area under the plasma concentration-time curve (AUC)
timeFrame: 1.5years
measure: T1/2
timeFrame: 1.5years
measure: elimination rate constant
timeFrame: 1.5years
measure: ADA
timeFrame: 1.5years
measure: objective response rate (ORR)
timeFrame: 1.5years
measure: disease control rate (DCR)
timeFrame: 1.5years
measure: duration of response (DOR)
timeFrame: 1.5years
measure: progression-free survival (PFS)
timeFrame: 1.5years
measure: overall survival (OS)
timeFrame: 1.5years
Other outcomes:
measure: Cytokines
timeFrame: 1.5years
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
city: Fujian
country: China
facility: Fujian Cancer hospital
state: Fuzhou
city: Zhejiang
country: China
facility: The First Affiliated Hospital of Zhejiang Medical University
state: Hangzhou
city: Heilongjiang
country: China
facility: Harbin Medical University Cancer Hospital
state: Harbin
city: Shandong
country: China
facility: Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)
state: Jinan
city: Guangdong
country: China
facility: Meizhou People's Hospital
state: Meizhou
city: Shenyang
country: China
facility: The First Affiliated Hospital of China Medical University
state: Shenyang
city: Hebei
country: China
facility: Hebei General Hospital
state: Shijiazhuang
city: Hubei
country: China
facility: Union Hospital, Tongji Medical College
state: Wuhan
city: Hubei
country: China
facility: Hubei Cancer Hospital
state: Wuhan
Study officials:
References: