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

NCT06832982 | Recruiting Phase 1

• 1 other identifier: FS-8002-001-CN
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 10

Brief 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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (11)

• peak concentration (Cmax)

  1.5years

• peak time (Tmax)

  1.5years

• area under the plasma concentration-time curve (AUC)

  1.5years

• T1/2

  1.5years

• elimination rate constant

  1.5years

Other Outcomes (1)

• Cytokines

  1.5years

Study Arms (3)

Single dose escalation

EXPERIMENTAL

42patients for dose escalation ,total 6 dose group

Drug: FS-8002 injection

Combination therapy-FS8002 and Toripalimab Injection

EXPERIMENTAL

Toripalimab Injection and FS8002

Drug: FS-8002 injection; Combination Product: Toripalimab Injection

Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy

EXPERIMENTAL

Toripalimab Injection and FS8002 and Chemotherapy

Drug: FS-8002 injection; Combination Product: Toripalimab Injection; Combination Product: Chemotherapy

Interventions

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

Combination therapy-FS8002 and Toripalimab Injection; Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy; Single dose escalation

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

Combination therapy-FS8002 and Toripalimab Injection; Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy

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

Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Shanghai Pushi Medical Science Co. Ltd: lead

Study Sites (10)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

Fujian Cancer hospital

Fujian, Fuzhou, 350013, China

RECRUITING

The First Affiliated Hospital of Zhejiang Medical University

Zhejiang, Hangzhou, 310003, China

RECRUITING

Harbin Medical University Cancer Hospital

Heilongjiang, Harbin, 150081, China

RECRUITING

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

Shandong, Jinan, 250117, China

RECRUITING

Meizhou People's Hospital

Guangdong, Meizhou, 514031, China

RECRUITING

The First Affiliated Hospital of China Medical University

Shenyang, Shenyang, 110001, China

RECRUITING

Hebei General Hospital

Hebei, Shijiazhuang, 050010, China

RECRUITING

Union Hospital, Tongji Medical College

Hubei, Wuhan, 430022, China

RECRUITING

Hubei Cancer Hospital

Hubei, Wuhan, 430079, China

RECRUITING

MeSH Terms

Interventions

toripalimab; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Xiaojun Wang, Master

CONTACT

021-50796193; xiaojun_wang@junshipharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: February 24, 2025
• Primary Completion (Estimated): February 19, 2028
• Study Completion (Estimated): February 19, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)