Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: FS-8002 injection

• Registration Number: NCT06832982
• Lead Sponsor: Shanghai Pushi Medical Science Co. Ltd

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-13
• Study First Submitted: 2025-02-13
• Study First Submitted QC: 2025-02-17
• Study First Posted: 2025-02-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2025-09-26
• Study Completion: 2026-09-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 54

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose escalation and dose extension	FS-8002 injection	30 patients for dose escalation ,total 6 dose group(30 mg、90 mg、270 mg、600 mg、1000 mg、1500 mg），24 patients for dose extension

Primary Outcome Measures

Name	Time	Method
SAE	2years	incidence and serverity of serious adverse events(SAE)
RP2D	1.5years	the phase II recommended dose(RP2D)
DLT	1 years	incidence and serverity of DLT
AE	2years	incidence and serverity of adverse events(AE)
MTD	1.5years	the maximum tolerated dose(MTD)

Secondary Outcome Measures

Name	Time	Method
peak concentration (Cmax)	1.5years	the pharmacokinetic parameters of FS-8002: peak concentration (Cmax)
peak time (Tmax)	1.5years	the pharmacokinetic parameters of FS-8002: peak time (Tmax)
area under the plasma concentration-time curve (AUC)	1.5years	the pharmacokinetic parameters of FS-8002: area under the plasma concentration-time curve (AUC)
T1/2	1.5years	the pharmacokinetic parameters of FS-8002: Terminal half-life
elimination rate constant	1.5years	the pharmacokinetic parameters of FS-8002: elimination rate constant
ADA	1.5years	Anti-drug antibody
objective response rate (ORR)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)
disease control rate (DCR)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
duration of response (DOR)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
progression-free survival (PFS)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
overall survival (OS)	1.5years	According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS)

Trial Locations

Locations (10)

Union Hospital, Tongji Medical College; 🇨🇳 Hubei, Wuhan, China

Hubei Cancer Hospital; 🇨🇳 Hubei, Wuhan, China

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital); 🇨🇳 Shandong, Jinan, China

Hebei General Hospital; 🇨🇳 Hebei, Shijiazhuang, 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

The First Affiliated Hospital of China Medical University; 🇨🇳 Shenyang, Shenyang, China

Meizhou People's Hospital; 🇨🇳 Guangdong, Meizhou, China