Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06832982

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

Led by Shanghai Pushi Medical Science Co. Ltd · Updated on 2026-04-09

66

Participants Needed

10

Research Sites

155 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with advanced solid tumors confirmed by histology or cytology who have failed or cannot tolerate standard treatments, or lack a standard regimen. GBM patients must have primary GBM with first recurrence after radiochemotherapy.
  • At least one measurable lesion per RECIST V1.1 or RANO 2.0 (GBM only), untreated or progressing in previous local treatment area.
  • Sufficient organ and bone marrow function.
Not Eligible

You will not qualify if you...

  • Previous treatment with TGF-β inhibitors, bevacizumab, or other VEGF/VEGFR-targeted drugs (for GBM patients).
  • Use of any experimental drug within 4 weeks before first study drug administration.
  • Systemic anti-tumor therapy within 4 weeks or 5 half-lives (whichever shorter) before first study drug dose, including chemotherapy, radiotherapy, immunotherapy, hormone therapy, targeted therapy, or immunomodulators.
  • Use of Chinese herbal or proprietary anti-tumor medicines within 2 weeks before study drug.
  • For GBM patients: less than 12 weeks from end of radiotherapy, less than 24 days from last TMZ treatment, or less than 6 weeks from last carmustine treatment.
  • Use of aspirin ≥325 mg/day or other anti-platelet or full-dose anticoagulant drugs within 2 weeks before study drug.
  • Major surgery or significant trauma within 4 weeks before study drug.
  • History of fistula, gastrointestinal perforation, tumor invasion of large blood vessels within 6 months before study drug.
  • Intestinal obstruction during screening period.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 10 locations

1

Beijing Cancer Hospital

Beijing, Beijing Municipality, China, 100142

Actively Recruiting

2

Fujian Cancer hospital

Fujian, Fuzhou, China, 350013

Actively Recruiting

3

The First Affiliated Hospital of Zhejiang Medical University

Zhejiang, Hangzhou, China, 310003

Actively Recruiting

4

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, China, 150081

Actively Recruiting

5

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)

Shandong, Jinan, China, 250117

Actively Recruiting

6

Meizhou People's Hospital

Guangdong, Meizhou, China, 514031

Actively Recruiting

7

The First Affiliated Hospital of China Medical University

Shenyang, Shenyang, China, 110001

Actively Recruiting

8

Hebei General Hospital

Hebei, Shijiazhuang, China, 050010

Actively Recruiting

9

Union Hospital, Tongji Medical College

Hubei, Wuhan, China, 430022

Actively Recruiting

10

Hubei Cancer Hospital

Hubei, Wuhan, China, 430079

Actively Recruiting

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Research Team

X

Xiaojun Wang, Master

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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