Advanced Solid TumorsPhase 1NCT06832982
Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacokinetics, and Preliminary Efficacy of FS-8002
A Phase 1 study testing FS-8002 injection, Toripalimab Injection and Chemotherapy in people with Advanced Solid Tumors, run by Shanghai Pushi Medical Science Co. Ltd at 10 sites in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- FS-8002 injection, Toripalimab Injection and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 10 sitesChina
- Study dates
- 24 Feb 2025to 19 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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. Cohort 1 includes patients with advanced solid tumours confirmed by histology/cytology/imaging (limited exclusively to HCC), who have experienced treatment failure with standard therapy, are intolerant to it, or lack standardized therapeutic options; however enrollment allows unresectable/metastatic HCC patients without prior systemic anti-cancer therapies; Cohort 2 comprises locally advanced/unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma (G/GEJA) patients confirmed via histological/cytological diagnosis whose initial line of immunotherapy combined with fluoropyrimidine + platinum-based chemotherapy has failed - excluding cases where the last administration occurred more than six months before recurrence during adjuvant/neoadjuvant settings;
- 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;
Who cannot join
- 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;
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, Doctor
Lin Shen
- Recruiting
Fujian Cancer hospital
Fujian, Fuzhou, 350013
Rongbo Lin, Master
Rongbo Lin, Master
- Recruiting
Meizhou People's Hospital
Guangdong, Meizhou, 514031
Xiwen Huang, Bachelor
Xiwen Huang, Bachelor
- Recruiting
Hebei General Hospital
Hebei, Shijiazhuang, 050010
Peng Li, Doctor
Peng Li, Doctor
- Recruiting
Harbin Medical University Cancer Hospital
Heilongjiang, Harbin, 150081
Tongsen Zheng, Doctor
Tongsen Zheng, Doctor
- Recruiting
Union Hospital, Tongji Medical College
Hubei, Wuhan, 430022
Hongli Liu, Doctor
Hongli Liu, Doctor
- Recruiting
Hubei Cancer Hospital
Hubei, Wuhan, 430079
Xinjun Liang, Doctor
Xinjun Liang, Doctor
- Recruiting
Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute,Shandong Cancer Hospital)
Shandong, Jinan, 250117
Shuqin Ni, Doctor
Shuqin Ni, Doctor
- Recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Shenyang, 110001
Funan Liu, Doctor
Funan Liu, Doctor
- Recruiting
The First Affiliated Hospital of Zhejiang Medical University
Zhejiang, Hangzhou, 310003
Jianzhen Shan, Doctor, 0571-87236560, zyy_sr@qq.com
Jian Liu, Doctor, 0571-87236560, lindaliu87@zju.edu.cn
About this study
Official 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
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
- Being tested
- FS-8002 injection, Toripalimab Injection, Chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FS-8002 injectionDrug
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 InjectionCombination 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
ChemotherapyCombination 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
| Study group | Role | What they receive |
|---|---|---|
| Single dose escalation | Experimental | 42patients for dose escalation ,total 6 dose group Receives: Drug: FS-8002 injection |
| Combination therapy-FS8002 and Toripalimab Injection | Experimental | Toripalimab Injection and FS8002 Receives: Drug: FS-8002 injection; Combination Product: Toripalimab Injection |
| Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy | Experimental | Toripalimab Injection and FS8002 and Chemotherapy Receives: Drug: FS-8002 injection; Combination Product: Toripalimab Injection; Combination Product: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
the maximum tolerated dose(MTD)
Measured: 1.5years
RP2D
the phase II recommended dose(RP2D)
Measured: 1.5years
DLT
incidence and serverity of DLT
Measured: 1 years
AE
incidence and serverity of adverse events(AE)
Measured: 2years
SAE
incidence and serverity of serious adverse events(SAE)
Measured: 2years
Secondary outcomes (11)
peak concentration (Cmax)
the pharmacokinetic parameters of FS-8002: peak concentration (Cmax)
Measured: 1.5years
peak time (Tmax)
the pharmacokinetic parameters of FS-8002: peak time (Tmax)
Measured: 1.5years
area under the plasma concentration-time curve (AUC)
the pharmacokinetic parameters of FS-8002: area under the plasma concentration-time curve (AUC)
Measured: 1.5years
T1/2
the pharmacokinetic parameters of FS-8002: Terminal half-life
Measured: 1.5years
elimination rate constant
the pharmacokinetic parameters of FS-8002: elimination rate constant
Measured: 1.5years
ADA
Anti-drug antibody
Measured: 1.5years
objective response rate (ORR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate objective response rate (ORR)
Measured: 1.5years
disease control rate (DCR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate disease control rate (DCR)
Measured: 1.5years
duration of response (DOR)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate duration of response (DOR)
Measured: 1.5years
progression-free survival (PFS)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate progression-free survival (PFS)
Measured: 1.5years
overall survival (OS)
According to the efficacy evaluation criteria for solid tumors version 1.1 (RECIST V1.1): to evaluate overall survival (OS)
Measured: 1.5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start24 Feb 2025
- Primary completion19 Feb 2028 (estimated)
- Study completion19 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pushi Medical Science Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06832982
- Sponsor's protocol ID
- FS-8002-001-CN
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2025
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06832982
- Acronym / sponsor ID
- FS-8002-001-CN
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Shanghai Pushi Medical Science Co. LtdIndustry (pharma, biotech, devices)
- Study start
- 24 Feb 2025 (actual)
- Primary completion
- 19 Feb 2028 (estimated)
- Study completion
- 19 Feb 2028 (estimated)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single dose escalation | Experimental | Drug: FS-8002 injection42patients for dose escalation ,total 6 dose group |
| Combination therapy-FS8002 and Toripalimab Injection | Experimental | Drug: FS-8002 injection, Combination Product: Toripalimab InjectionToripalimab Injection and FS8002 |
| Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy | Experimental | Drug: FS-8002 injection, Combination Product: Toripalimab Injection, Combination Product: ChemotherapyToripalimab Injection and FS8002 and Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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. Cohort 1 includes patients with advanced solid tumours confirmed by histology/cytology/imaging (limited exclusively to HCC), who have experienced treatment failure with standard therapy, are intolerant to it, or lack standardized therapeutic options; however enrollment allows unresectable/metastatic HCC patients without prior systemic anti-cancer therapies; Cohort 2 comprises locally advanced/unresectable/metastatic gastric/gastroesophageal junction adenocarcinoma (G/GEJA) patients confirmed via histological/cytological diagnosis whose initial line of immunotherapy combined with fluoropyrimidine + platinum-based chemotherapy has failed - excluding cases where the last administration occurred more than six months before recurrence during adjuvant/neoadjuvant settings;
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FS-8002 injectionQ3W or until the patient develops PD, intolerable toxicity, death, loss of follow-up, voluntary withdrawal, or the end of the study, whichever occurs first | Drug | Combination therapy-FS8002 and Toripalimab Injection, Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy, Single dose escalation |
| Toripalimab InjectionQ3W 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 product | Combination therapy-FS8002 and Toripalimab Injection, Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy |
| ChemotherapyAdministrated 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 product | Combination therapy-FS8002 and Toripalimab Injection and Chemotherapy |
Primary outcome
MTD
Time frame: 1.5years
the maximum tolerated dose(MTD)
RP2D
Time frame: 1.5years
the phase II recommended dose(RP2D)
DLT
Time frame: 1 years
incidence and serverity of DLT
AE
Time frame: 2years
incidence and serverity of adverse events(AE)
SAE
Time frame: 2years
incidence and serverity of serious adverse events(SAE)
11 secondary outcomes
peak concentration (Cmax)
Time frame: 1.5years
peak time (Tmax)
Time frame: 1.5years
area under the plasma concentration-time curve (AUC)
Time frame: 1.5years
T1/2
Time frame: 1.5years
elimination rate constant
Time frame: 1.5years
ADA
Time frame: 1.5years
objective response rate (ORR)
Time frame: 1.5years
disease control rate (DCR)
Time frame: 1.5years
duration of response (DOR)
Time frame: 1.5years
progression-free survival (PFS)
Time frame: 1.5years
overall survival (OS)
Time frame: 1.5years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FS-8002 injection, Toripalimab Injection and Chemotherapy in people with Advanced Solid Tumors, run by Shanghai Pushi Medical Science Co. Ltd at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojun Wang, Master (021-50796193, xiaojun_wang@junshipharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: 1.5years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.