RecruitingPhase 1NCT06832982

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


Sponsor

Shanghai Pushi Medical Science Co. Ltd

Enrollment

66 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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;
  • 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;
  • The subject has sufficient organ and bone marrow function;

Exclusion Criteria5

  • 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);
  • Have received any experimental drug treatment within 4 weeks prior to the first administration of the investigational drug;
  • 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;
  • 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;
  • 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;

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Interventions

DRUGFS-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_PRODUCTToripalimab 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_PRODUCTChemotherapy

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


Locations(10)

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

Union Hospital, Tongji Medical College

Hubei, Wuhan, China

Hubei Cancer Hospital

Hubei, Wuhan, China

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NCT06832982


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