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

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

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

Study Overview

• Status: Recruiting
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: FS-8002 injection; Combination product: Toripalimab Injection; Combination product: Chemotherapy

• Study Type: Interventional
• Enrollment (Estimated): 66
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Xiaojun Wang, Master; Phone Number: 021-50796193; Email: xiaojun_wang@junshipharma.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100142
      • Recruiting
      • Beijing Cancer Hospital
      • Principal Investigator: Lin Shen
      • Contact: Lin Shen, Doctor
  • Fuzhou
    • Fujian, Fuzhou, China, 350013
      • Recruiting
      • Fujian Cancer Hospital
      • Contact: Rongbo Lin, Master
      • Principal Investigator: Rongbo Lin, Master
  • Hangzhou
    • Zhejiang, Hangzhou, China, 310003
      • Recruiting
      • The First Affiliated Hospital of Zhejiang Medical University
      • Principal Investigator: Jian Liu, Doctor
      • Principal Investigator: Jianzhen Shan, Doctor
      • Contact: Jianzhen Shan, Doctor; Phone Number: 0571-87236560; Email: zyy_sr@qq.com
      • Contact: Jian Liu, Doctor; Phone Number: 0571-87236560; Email: lindaliu87@zju.edu.cn
  • Harbin
    • Heilongjiang, Harbin, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Tongsen Zheng, Doctor
      • Principal Investigator: Tongsen Zheng, Doctor
  • Jinan
    • Shandong, Jinan, China, 250117
      • Recruiting
      • Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)
      • Contact: Shuqin Ni, Doctor
      • Principal Investigator: Shuqin Ni, Doctor
  • Meizhou
    • Guangdong, Meizhou, China, 514031
      • Recruiting
      • Meizhou People's Hospital
      • Contact: Xiwen Huang, Bachelor
      • Principal Investigator: Xiwen Huang, Bachelor
  • Shenyang
    • Shenyang, Shenyang, China, 110001
      • Recruiting
      • The First Affiliated Hospital of China Medical University
      • Principal Investigator: Funan Liu, Doctor
      • Contact: Funan Liu, Doctor
  • Shijiazhuang
    • Hebei, Shijiazhuang, China, 050010
      • Recruiting
      • Hebei General Hospital
      • Contact: Peng Li, Doctor
      • Principal Investigator: Peng Li, Doctor
      • Principal Investigator: Yibing Liu, Doctor
  • Wuhan
    • Hubei, Wuhan, China, 430022
      • Recruiting
      • Union Hospital, Tongji Medical College
      • Contact: Hongli Liu, Doctor
      • Principal Investigator: Hongli Liu, Doctor
    • Hubei, Wuhan, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
      • Principal Investigator: Xinjun Liang, Doctor
      • Contact: Xinjun Liang, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.GBM patients must be primary GBM and first recurrence after adjuvant radiochemotherapy;
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:

1. Patients who have previously received TGF-β inhibitor therapy. previous treatment with bevacizumab or other VEGF or VEGFR-targeted drugs (only for patients with GBM);
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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose escalation; 42patients for dose escalation ,total 6 dose group	Drug: 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
Experimental: Combination therapy-FS8002 and Toripalimab Injection; Toripalimab Injection and FS8002	Drug: 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; Combination product: Toripalimab 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
Experimental: Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy; Toripalimab Injection and FS8002 and Chemotherapy	Drug: 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; Combination product: Toripalimab 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; Combination product: Chemotherapy; Administrated per the chemotherapy chosed by the investigator until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cytokines	Cytokines: interferon gamma (IFN-γ), interleukin (IL) -2, IL-10, IL-12, and IL-15.	1.5years

Collaborators and Investigators

• Sponsor: Shanghai Pushi Medical Science Co. Ltd

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2025
• Primary Completion (Estimated): February 19, 2028
• Study Completion (Estimated): February 19, 2028

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 18, 2025

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; toripalimab; Drug Therapy
• Other Study ID Numbers: FS-8002-001-CN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No