Advanced Hepatocellular Carcinoma (HCC)Phase 1/2NCT07540832
A Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC
A Phase 1/2 study testing WGI-0301 and Lenvatinb in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang Haichang Biotech Co., Ltd. at 1 site in United States.
Trial summary
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma (HCC)
- What is being tested?
- WGI-0301 and Lenvatinb
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Oct 2028
- Phase
- Phase 1/2
- 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
- ≥18 years of age on the day of signing informed consent, male or female.
- Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.
- Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per AASLD criteria.
- BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6).
- Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) or intolerance with no restriction on the number of prior lines of systemic treatment.
- Stage 2 only: Patients must have objective radiographic disease progression or intolerance after only one prior line of systemic immunotherapy treatment with an anti-PD-1/ PD-L1 mAb administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies (Prior locoregional therapy such as surgery, radiofrequency ablation or trans-arterial chemoembolization are also allowed but not counted as systemic therapy, provided that progression has been documented after these therapies, and ≥4 weeks have elapsed since the last therapy).
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- Eligible for treatment with Lenvatinib, as determined by investigators according to the Package Insert and clinical judgment.
- ECOG PS of 0 or 1 within 7 days prior to the first dose of study intervention (ECOG PS see Appendix 3 in Section 14.3).
- Patients must have at least one measurable lesion according to RECIST 1.1 as determined by the investigator, and that has not been the target of local or regional therapy including trans-arterial chemoembolization, intra-arterial chemotherapy, ethanol, or radiofrequency ablation; a new area of tumor progression within or adjacent to a previously treated lesion, if clearly measurable by a radiologist, is acceptable.
- Life expectancy in the judgement of the Investigator > 12 weeks.
- Recovery to ≤ Grade 1 (CTCAE V6.0) from toxicities related to any prior treatments unless the adverse events are clinically non-significant and/ or stable on supportive therapy, such as alopecia, Grade 2 peripheral neuropathy, and hypothyroidism stabilized on hormone replacement therapy.
- Collection of an archived tissue sample will be requested (where available) or agree to undergo tumor tissue biopsy for biomarker testing; however, a subject will not be precluded from participating in the study if tissue sample is not available for collection or is otherwise insufficient for analysis.
- Patients must have adequate organ function as defined below:
- Child-Pugh Liver Function Class A or Class B (score ≤ 7) (see Appendix 6 in Section 14.6)
- AST and ALT ≤ 3.0 × ULN, and total bilirubin ≤ 2 × ULN
- Serum albumin ≥ 2.8 g/ dL
- CrCL ≥ 50 ml/ min (Cockcroft-Gault formula: CrCL (mL/ min) = [140-age(year)] × body weight (Kg)/ [72 × Scr (mg/ dl)]{ × 0.85 for female subjects})
- Urine protein < 2+ by dipstick analysis; if urine protein is ≥ 2+, a 24-hour urine protein quantification must be performed. Patients with 24-hour urine protein ≥ 1 g will be excluded.
- International normalized ratio (INR) ≤ 2.0 (except for warfarin therapy)
- Hemoglobin ≥ 8.5 g/ dL, absolute neutrophil count > 1000/ mm3, platelet count ≥ 60 000/ mm3 (no blood transfusion, blood products, cell growth factors, albumin or any other corrective therapeutic drugs within 14 days)
- Participants with HBV or HCV infection will be allowed if they meet the following criteria:
- HBV-HCC: Resolved HBV infection (as evidenced by detectable HBV surface antibody, detectable HBV core antibody, undetectable HBV DNA, and undetectable HBV surface antigen) or chronic HBV infection (as evidenced by detectable HBV surface antigen or HBV DNA). Subjects with chronic HBV infection must have HBV DNA < 500 IU/ mL and should be managed according to treatment guidelines. Those on antiviral therapy at screening should have been treated for >2 weeks before the first dose.
- HCV-HCC: Resolved HCV infection (as evidenced by undetectable HCV RNA), or stable HCV infection (such as normal LFTs or being asymptomatic). Patients with positive HCV RNA requiring direct antiviral agent treatment, or those with HBV and HCV co-infection are excluded.
- WOCBP must have a negative serum pregnancy within 3 days prior to receiving the first dose of study medication and must use accepted highly effective methods of contraception from the time of signing the informed consent through 6 months after the last dose of study drug. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, or be surgically sterile, for the duration of study participation, and for 3 months after completion of study drug administration. See Appendix 1 for protocol-approved highly effective methods of contraceptive combinations.
Who cannot join
- Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein).
- Major surgery within 4 weeks prior to the first dose of study intervention, or presence of any serious unhealed wounds, ulcers, or untreated fractures at screening.
- Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs or related excipients.
- Previous identified allergy or hypersensitivity to components of Lenvatinib or similar drugs.
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- Stage 2 only: Has received prior Lenvatinib therapy or treatment with any agents targeting the PI3K/AKT pathway.
- Currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention.
- Locoregional therapy to the liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).
- Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose.
- Clinically significant abnormalities of glucose metabolism (e.g., Patients with diabetes mellitus type1 or diabetes mellitus type 2 requiring treatment, or those with HbA1c ≥8.0%.
- Clinically significant cardiovascular disease including:
- Uncontrolled chronic hypertension, defined as systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥ 90 mmHg based on the average of ≥ 2 measurements; or a history of hypertensive crisis or hypertensive encephalopathy.
- Clinically significant hypotension as assessed by the investigator (e.g., systolic blood pressure < 90 mmHg or mean arterial pressure < 65 mmHg on two consecutive measurements at the Screening Visit).
- NYHA class III or IV Congestive heart failure, myocardial infarction or stroke, unstable angina pectoris, pericardial effusion (excluding trace pericardial effusion identified by echocardiography) or left ventricular ejection fraction < 45% within 6 months prior to the first dose.
- Primary cardiomyopathy (e.g., dilated cardiomyopathy, hypertrophic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, restrictive cardiomyopathy, indeterminate cardiomyopathy).
- Bradycardia (known history of cardiovascular disease and either physical examination at rest or electrocardiogram indicating heart rate < 50 bpm), or screening ECG indicating QTcF > 470 msec, 2 retests were required for the first abnormal QTcF, and 3 mean values were taken. Or there is severe arrhythmia requiring further treatment, including but not limited to ventricular fibrillation, atrial fibrillation, sustained ventricular tachycardia, second-degree or third-degree atrioventricular block, torsades de pointes, etc.
- Clinically significant gastrointestinal disorders including:
- Medical history of difficulty swallowing, malabsorption, or other chronic gastrointestinal disease, or conditions that may hamper compliance and/or absorption of the tested products.
- Gastrointestinal perforation and/ or fistula intra-abdominal abscess or intestinal obstruction within 6 months prior to the first dose.
- Clinically significant gastric bleeding within 6 months prior to the first dose (patients may be enrolled if esophageal and gastric varices are present on imaging, but no bleeding event or inpatient medical intervention occurs within 6 months prior to the first dose).
- Clinically significant bleeding risks including:
- Known hereditary or acquired bleeding or thrombotic tendencies (e.g., hereditary hemorrhagic telangiectasia or von Willebrand disease)
- Bleeding symptoms such as hemoptysis (> half teaspoon bright red blood) and gastrointestinal bleeding within 3 months prior to screening
- Thrombolytic agents within 10 days prior to the first dose
- Receiving anticoagulant therapy (e.g., anticoagulants, antiplatelets), and subject 's INR and APTT are not within expected therapeutic range of anticoagulant (except sodium heparin for maintenance of central venous catheter patency)
- History of solid organ transplant.
- Known HIV or AIDS related illness or is receiving systemic steroid therapy (prednisone <10 mg/day or equivalent doses of other corticosteroids are acceptable) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
- Known active or uncontrolled infection that could interfere with the study (such as requiring intravenous antibiotics, antiviral or antifungal medications).
- Uncontrolled ascites or pleural effusion requiring repeated drainage (Investigator 's judgment).
- Past or current history of neoplasm other than HCC, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix, or other cancer curatively treated and with no evidence of disease for at least 3 years.
- Known CNS or leptomeningeal metastasis that is either symptomatic or untreated (except for asymptomatic cases not requiring treatment).
- History of drug abuse or addiction at the present stage.
- Subject has any other conditions or reason that, in the opinion of the Investigator, interferes with the ability of the subject to participate in the trial, places the subject at undue risk or complicates the interpretation of data
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: An Open-Label Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy
This is a Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer.
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Being tested
- WGI-0301, Lenvatinb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WGI-0301Drug
WGI-0301 at Maximum Tolerated Dose (MTD)
WGI-0301Drug
WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1)
LenvatinbDrug
Lenvatinib for patients with body weight of <60 kg: 8 mg orally daily, for patients with body weight ≥60 kg: 12 mg orally daily
| Study group | Role | What they receive |
|---|---|---|
| WGI-0301 Plus Lenvatinib at MTD | Experimental | Not described Receives: Drug: WGI-0301; Drug: Lenvatinb |
| WGI-0301 Plus Lenvatinib at Dose Level Below MTD | Experimental | Not described Receives: Drug: WGI-0301; Drug: Lenvatinb |
| Lenvatinib Only | Active comparator | Not described Receives: Drug: Lenvatinb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of WGI-0301 in Combination with Lenvatinib
Efficacy will be assessed via Objective Response Rate (ORR), as determined by investigator using RECIST 1.1.
Measured: 24 months
Secondary outcomes (7)
Safety and tolerability of WGI-0301 in combination with Lenvatinib
Determined by number of AEs, SAEs
Measured: 24 months
Peak Plasma Concentration (Cmax)
Drug Concentration in the boold will be used to determine Peak Plasma Concentration (Cmax)
Measured: 28 days
Tmax (Time to peak drug concentration)
Drug Concentration in the boold will be used to determine Tmax (Time to peak drug concentration)
Measured: 28 days
Area under the Curve (AUC)
Drug Concentration in the boold will be used to determine Area under the Curve (AUC)
Measured: 28 days
Disease Control Rate (DCR)
Percentage of Patients with Partial Response (PR) or Stable Disease (SD) at the end of treatment
Measured: 24 months
Progression-Free Survival (PFS)
The duration from randomization to disease progression
Measured: 24 months
Overall Survival (OS)
The duration from randomization to death
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Hepatocellular Carcinoma (HCC)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Haichang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540832
- Sponsor's protocol ID
- WGI0301-P2G-03
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced Hepatocellular Carcinoma as Second Line Therapy
- ClinicalTrials.gov ID
- NCT07540832
- Acronym / sponsor ID
- WGI0301-P2G-03
- Conditions
- Advanced Hepatocellular Carcinoma (HCC)
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Zhejiang Haichang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 20 Apr 2026 (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 Phase II study being done at several hospitals without using a placebo. It will look at how safe and tolerable the drug WGI-0301 is when given together with Lenvatinib, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| WGI-0301 Plus Lenvatinib at MTD | Experimental | Drug: WGI-0301, Drug: Lenvatinb |
| WGI-0301 Plus Lenvatinib at Dose Level Below MTD | Experimental | Drug: WGI-0301, Drug: Lenvatinb |
| Lenvatinib Only | Active comparator | Drug: Lenvatinb |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- ≥18 years of age on the day of signing informed consent, male or female.
- Voluntarily agree to provide signed informed consent and are willing and able to comply with all aspects of the protocol.
- Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per AASLD criteria.
- BCLC Stage C or BCLC Stage B with bilobar involvement and infiltrative nature that is only suitable for systemic anti-tumor therapy, and not suitable for any curative surgeries, liver transplantation, or local therapy (BCLC Classification see Appendix 6, Section 14.6).
- Stage 1 only: At least first-line standard treatment failure (disease progression confirmed by imaging) or intolerance with no restriction on the number of prior lines of systemic treatment.
Key exclusion criteria (34 listed)
- Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
- Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma.
- Complete occlusion of the major portal vein or vena cava due to HCC (The major portal vein is defined as the part of portal vein between the union of the splenic and superior mesenteric veins and the first bifurcation into the left and right vein).
- Major surgery within 4 weeks prior to the first dose of study intervention, or presence of any serious unhealed wounds, ulcers, or untreated fractures at screening.
- Previous identified allergy or hypersensitivity to components of WGI-0301 similar drugs or liposomal drugs or related excipients.
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 |
|---|---|---|
| WGI-0301WGI-0301 at Maximum Tolerated Dose (MTD) | Drug | WGI-0301 Plus Lenvatinib at MTD |
| WGI-0301WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1) | Drug | WGI-0301 Plus Lenvatinib at Dose Level Below MTD |
| LenvatinbLenvatinib for patients with body weight of <60 kg: 8 mg orally daily, for patients with body weight ≥60 kg: 12 mg orally daily | Drug | Lenvatinib Only, WGI-0301 Plus Lenvatinib at Dose Level Below MTD, WGI-0301 Plus Lenvatinib at MTD |
Primary outcome
Efficacy of WGI-0301 in Combination with Lenvatinib
Time frame: 24 months
Efficacy will be assessed via Objective Response Rate (ORR), as determined by investigator using RECIST 1.1.
7 secondary outcomes
Safety and tolerability of WGI-0301 in combination with Lenvatinib
Time frame: 24 months
Peak Plasma Concentration (Cmax)
Time frame: 28 days
Tmax (Time to peak drug concentration)
Time frame: 28 days
Area under the Curve (AUC)
Time frame: 28 days
Disease Control Rate (DCR)
Time frame: 24 months
Progression-Free Survival (PFS)
Time frame: 24 months
Overall Survival (OS)
Time frame: 24 months
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 15 Sep 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing WGI-0301 and Lenvatinb in people with Advanced Hepatocellular Carcinoma (HCC), run by Zhejiang Haichang Biotech Co., Ltd. at 1 site in United States.
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 24 inclusion and 34 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 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Angela Men (240-702-0080, angela.men@thewogroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of WGI-0301 in Combination with Lenvatinib (time frame: 24 months). 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 15 Sep 2026.