Evaluating FS-8002 for advanced solid tumors

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 study is testing a new treatment called FS-8002 to see if it is safe and effective for people with advanced solid tumors who have not responded to or cannot tolerate standard therapies.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Pushi Medical Science Co. Ltd (industry)
• Drugs / interventions: bevacizumab, chemotherapy, immunotherapy
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT06832982 on ClinicalTrials.gov

What this trial studies

This is a single-arm, open-label Phase I clinical trial that assesses the safety, tolerability, pharmacokinetics, and preliminary efficacy of FS-8002 in patients with advanced solid tumors. Participants must have tumors confirmed by histology or cytology and have either failed or become intolerant to standard treatments. The study aims to gather initial data on how well FS-8002 is tolerated and its potential effectiveness in this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with advanced solid tumors who have not responded to or cannot tolerate existing standard therapies.

Not a fit: Patients who have previously received TGF-β inhibitor therapy or those currently undergoing other systemic anti-tumor treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: While this approach is being explored in this specific context, similar studies evaluating new treatments for advanced solid tumors have shown promise in the past.

Eligibility criteria

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;

Where this trial is running

Beijing, Beijing Municipality and 9 other locations

• Beijing Cancer Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Fujian Cancer hospital — Fujian, Fuzhou, China (RECRUITING)
• The First Affiliated Hospital of Zhejiang Medical University — Zhejiang, Hangzhou, China (RECRUITING)
• Harbin Medical University Cancer Hospital — Heilongjiang, Harbin, China (RECRUITING)
• Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital) — Shandong, Jinan, China (RECRUITING)
• Meizhou People's Hospital — Guangdong, Meizhou, China (RECRUITING)
• The First Affiliated Hospital of China Medical University — Shenyang, Shenyang, China (RECRUITING)
• Hebei General Hospital — Hebei, Shijiazhuang, China (RECRUITING)
• Union Hospital, Tongji Medical College — Hubei, Wuhan, China (RECRUITING)
• Hubei Cancer Hospital — Hubei, Wuhan, China (RECRUITING)

Study contacts

• Study coordinator: Xiaojun Wang, Master

Conditions: Advanced Solid Tumors