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NCT Number: NCT06832982

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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;

Treatment and study plan

FS-8002 injection

Drug

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

Toripalimab Injection

Combination Product

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

Chemotherapy

Combination Product

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

Primary outcomes

  1. MTD

    Time frame: 1.5years

    the maximum tolerated dose(MTD)

  2. RP2D

    Time frame: 1.5years

    the phase II recommended dose(RP2D)

  3. DLT

    Time frame: 1 years

    incidence and serverity of DLT

  4. AE

    Time frame: 2years

    incidence and serverity of adverse events(AE)

  5. SAE

    Time frame: 2years

    incidence and serverity of serious adverse events(SAE)

Secondary outcomes

  1. peak concentration (Cmax)

    Time frame: 1.5years

    the pharmacokinetic parameters of FS-8002: peak concentration (Cmax)

  2. peak time (Tmax)

    Time frame: 1.5years

    the pharmacokinetic parameters of FS-8002: peak time (Tmax)

  3. area under the plasma concentration-time curve (AUC)

    Time frame: 1.5years

    the pharmacokinetic parameters of FS-8002: area under the plasma concentration-time curve (AUC)

  4. T1/2

    Time frame: 1.5years

    the pharmacokinetic parameters of FS-8002: Terminal half-life

  5. elimination rate constant

    Time frame: 1.5years

    the pharmacokinetic parameters of FS-8002: elimination rate constant

  6. ADA

    Time frame: 1.5years

    Anti-drug antibody

  7. objective response rate (ORR)

    Time frame: 1.5years

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)

  8. disease control rate (DCR)

    Time frame: 1.5years

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)

  9. duration of response (DOR)

    Time frame: 1.5years

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)

  10. progression-free survival (PFS)

    Time frame: 1.5years

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)

  11. overall survival (OS)

    Time frame: 1.5years

    According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS)

Other outcomes

  1. Cytokines

    Time frame: 1.5years

    Cytokines: interferon gamma (IFN-γ), interleukin (IL) -2, IL-10, IL-12, and IL-15.

Study contacts

Contact information is provided by the study sponsor or research team.

Xiaojun Wang, Master

CONTACT

[email protected]

021-50796193

Sponsors and collaborators

Lead sponsor

Shanghai Pushi Medical Science Co. Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 18, 2025
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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