Advanced Hepatocellular CarcinomaEarly Phase 1NCT07201064
A Study of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma
A Early Phase 1 study testing SZ1003 injection in people with Advanced Hepatocellular Carcinoma, run by Guangdong ProCapZoom Biosciences Co., Ltd..
Trial summary
This study is a "3+3" dose-escalation, open-label, multiple-dose clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- SZ1003 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 25 Sep 2025to 30 Sep 2027
- Phase
- Early 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years old, including the boundary value, no gender restriction;
- Meet the diagnostic criteria for advanced hepatocellular carcinoma established by histopathology and/or cytology, and have experienced failure of second-line therapy for advanced HCC (per 2024 CSCO Guidelines for Primary Liver Cancer). Patients must have progressed during or after at least two prior lines of standard systemic therapy (intolerant or refractory), with radiologically documented disease progression. Eligible stages are Barcelona Clinic Liver Cancer stage B or C, or stage IIb/IIIa/IIIb as defined in the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (stage-IIb patients must be deemed unsuitable for surgery or TACE);
- Have at least one measurable or evaluable lesion per RECIST 1.1;
- GPC3 positivity confirmed by immunohistochemistry on a clinical pathology section;
- Child-Pugh classification: class A or class B (≤ 7 points) (See Appendix 1 for the Child-Pugh classification table).;
- ECOG performance status: the score is 0 or 1 (See Appendix 2 for the ECOG-PS scoring table);
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- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN or creatinine clearance (CCr) ≥ 50 mL/min by Cockcroft-Gault;
- Coagulation: INR, APTT, and PT ≤ 1.5 × ULN without anticoagulant therapy.
- Able to undergo routine peripheral venous blood collection, establish adequate venous access, and have no contraindications to peripheral blood procurement.
- Women of child-bearing potential must have a negative serum or urine pregnancy test within 14 days before enrollment and agree to use effective non-hormonal contraception (e.g., condoms, non-medicated IUD) throughout the trial to minimize the risk of pregnancy. Men with partners of child-bearing potential and women of child-bearing potential must maintain effective contraception from screening until 12 months after the last cell infusion.
- Willing to participate in the study, fully informed of the study and sign the informed consent form; willing to comply with all trial procedures.
Who cannot join
- Patients who have previously undergone liver transplantation, organ allotransplantation, allogeneic stem-cell transplantation, and renal-replacement therapy.
- Clinically detectable hepatic encephalopathy or those requiring pharmacological treatment for hepatic encephalopathy.
- Moderate-to-severe ascites attributable to portal hypertension or cirrhosis.
- History of leptomeningeal or central-nervous-system metastases.
- Neurologic disorder ≥ Grade 2 (CTCAE).
- Having experienced esophageal or gastric variceal bleeding due to portal hypertension within the past 3 months. Patients with evidence of portal hypertension and a high bleeding risk as assessed by the investigator.
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- Having experienced any life-threatening bleeding events within the past 3 months, including those requiring transfusion, surgery, local treatment, or continuous pharmacological therapy.
- History of stroke or central nervous system hemorrhage; Prior stroke, CNS hemorrhage, TIA, or RIND within 6 months.
- Uncontrolled hypertension (SBP > 140 mmHg or DBP > 90 mmHg despite optimal therapy), hypertensive crisis, or hypertensive encephalopathy.
- Symptomatic CHF (NYHA ClassII-IV), Symptomatic or poorly controlled arrhythmias. Electrocardiogram (ECG) showing clinically significant abnormalities, or QTc interval ≥ 450 milliseconds in men, ≥ 470 milliseconds in women (≥ 480 milliseconds for subjects with bundle branch block on consecutive ECGs) (calculated using Fridericia's formula).
- Severe bleeding diathesis, coagulopathy, or ongoing thrombolytic therapy.
- A history of or current pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, drug-related pneumonitis, or severely impaired pulmonary function.
- HBsAg-positive subjects with HBV-DNA above the lower limit of detection at the study site must receive at least 7 days of antiviral therapy before the first dose and are willing to continue antiviral treatment for hepatitis B as required during the study to be eligible for enrollment. HBsAg-negative but HBcAb-positive subjects with HBV-DNA below the lower limit of detection at the study site will be closely monitored for HBV-DNA and liver transaminase levels during the dosing period. If HBV reactivation occurs during the treatment period, these subjects must agree to immediately initiate antiviral therapy for hepatitis B to remain eligible. All such subjects must be willing to continue antiviral treatment for hepatitis B for at least 6 months after the last dose, and the investigator may follow up on hepatitis B markers based on individual patient circumstances. Active hepatitis C: HCV antibody-positive with HCV-RNA levels above the lower limit of detection at the study site; co-infection with hepatitis B and hepatitis C.
- Active tuberculosis (TB), subjects currently receiving anti-TB treatment or those who have received anti-TB treatment within 1 year before the first dose.
- HIV-positive or active syphilis.
- Subjects with active or poorly controlled serious infections; those who have had severe infections within 4 weeks before peripheral blood collection, including but not limited to hospitalization due to infection, bacteremia, or severe pneumonia complications.
- Active autoimmune disease requiring systemic therapy (immunosuppressants, corticosteroids, or DMARDs) within 2 years and not adequately controlled.
- History of malignancy (other than HCC) within 5 years.
- Known hypersensitivity to study drug or its components.
- Pregnant or lactating women.
- Subjects deemed unsuitable for participation in this trial by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma
This study is a "3+3" dose-escalation, open-label, multiple-dose clinical trial.
Read the detailed description
This study is a "3+3" dose-escalation, open-label, multiple-dose clinical trial. To evaluate the safety, tolerability, and preliminary efficacy of SZ1003 injection in patients with advanced hepatocellular carcinoma.
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- SZ1003 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SZ1003 injectionDrug
Also called SZ1003
once every two weeks at a dose of SZ1003 injection per infusion.
| Study group | Role | What they receive |
|---|---|---|
| SZ1003 injection | Experimental | once every two weeks at a dose of SZ1003 injection per infusion Receives: Drug: SZ1003 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Incidence and severity of adverse events from subjects receiving administration to Week 24 post-administration.
Measured: from subjects receiving administration to Week 24 post-administration
Serious adverse events
Incidence and severity of adverse events from subjects receiving administration to Week 24 post-administration.
Measured: from subjects receiving administration to Week 24 post-administration
Secondary outcomes (5)
Objective Response Rate
Every 8 weeks, objective response rate will be assessed according to RECIST 1.1..
Measured: from subjects receiving administration to Week 24 post-administration
Disease Control Rate
Every 8 weeks, disease control rate will be assessed according to RECIST 1.1..
Measured: from subjects receiving administration to Week 24 post-administration
Duration of Response
Every 8 weeks, duration of response will be assessed according to RECIST 1.1..
Measured: from subjects receiving administration to Week 24 post-administration
Progression-Free Survival
Every 8 weeks, progression-free survival will be assessed according to RECIST 1.1..
Measured: from subjects receiving administration to Week 24 post-administration
Overall Survival
Every 8 weeks, overall survival will be assessed according to RECIST 1.1..
Measured: from subjects receiving administration to Week 24 post-administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start25 Sep 2025 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular CarcinomaStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- multiple Group Assignment
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201064
- Sponsor's protocol ID
- PLKR-SZ1003-I-101
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of SZ1003 Injection in Patients With Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07201064
- Acronym / sponsor ID
- PLKR-SZ1003-I-101
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Guangdong ProCapZoom Biosciences Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Oct 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 study is a "3+3" dose-escalation, open-label, multiple-dose clinical trial.
Detailed description
This study is a "3+3" dose-escalation, open-label, multiple-dose clinical trial. To evaluate the safety, tolerability, and preliminary efficacy of SZ1003 injection in patients with advanced hepatocellular carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- multiple Group Assignment
| Arm | Type | Receives |
|---|---|---|
| SZ1003 injection | Experimental | Drug: SZ1003 injectiononce every two weeks at a dose of SZ1003 injection per infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years old, including the boundary value, no gender restriction;
- Meet the diagnostic criteria for advanced hepatocellular carcinoma established by histopathology and/or cytology, and have experienced failure of second-line therapy for advanced HCC (per 2024 CSCO Guidelines for Primary Liver Cancer). Patients must have progressed during or after at least two prior lines of standard systemic therapy (intolerant or refractory), with radiologically documented disease progression. Eligible stages are Barcelona Clinic Liver Cancer stage B or C, or stage IIb/IIIa/IIIb as defined in the 2024 Chinese Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (stage-IIb patients must be deemed unsuitable for surgery or TACE);
- Have at least one measurable or evaluable lesion per RECIST 1.1;
- GPC3 positivity confirmed by immunohistochemistry on a clinical pathology section;
- Child-Pugh classification: class A or class B (≤ 7 points) (See Appendix 1 for the Child-Pugh classification table).;
Key exclusion criteria (21 listed)
- Patients who have previously undergone liver transplantation, organ allotransplantation, allogeneic stem-cell transplantation, and renal-replacement therapy.
- Clinically detectable hepatic encephalopathy or those requiring pharmacological treatment for hepatic encephalopathy.
- Moderate-to-severe ascites attributable to portal hypertension or cirrhosis.
- History of leptomeningeal or central-nervous-system metastases.
- Neurologic disorder ≥ Grade 2 (CTCAE).
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 |
|---|---|---|
| SZ1003 injectionAlso: SZ1003once every two weeks at a dose of SZ1003 injection per infusion. | Drug | SZ1003 injection |
Primary outcome
Adverse events
Time frame: from subjects receiving administration to Week 24 post-administration
Incidence and severity of adverse events from subjects receiving administration to Week 24 post-administration.
Serious adverse events
Time frame: from subjects receiving administration to Week 24 post-administration
Incidence and severity of adverse events from subjects receiving administration to Week 24 post-administration.
5 secondary outcomes
Objective Response Rate
Time frame: from subjects receiving administration to Week 24 post-administration
Disease Control Rate
Time frame: from subjects receiving administration to Week 24 post-administration
Duration of Response
Time frame: from subjects receiving administration to Week 24 post-administration
Progression-Free Survival
Time frame: from subjects receiving administration to Week 24 post-administration
Overall Survival
Time frame: from subjects receiving administration to Week 24 post-administration
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 1 Oct 2025.
- 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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing SZ1003 injection in people with Advanced Hepatocellular Carcinoma, run by Guangdong ProCapZoom Biosciences Co., Ltd..
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 11 inclusion and 21 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: opening soon, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Jiexing Chen (18302002029, jxchen@procapzoom.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: from subjects receiving administration to Week 24 post-administration). The study lists 2 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 1 Oct 2025.