Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC

NCT07540832 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: WGI0301-P2G-03
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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 cancer.

Conditions

Advanced Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• 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.

  24 months

Secondary Outcomes (7)

• Safety and tolerability of WGI-0301 in combination with Lenvatinib

  24 months

• Peak Plasma Concentration (Cmax)

  28 days

• Tmax (Time to peak drug concentration)

  28 days

• Area under the Curve (AUC)

  28 days

• Disease Control Rate (DCR)

  24 months

Study Arms (3)

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

Interventions

WGI-0301 DRUG

WGI-0301 at Maximum Tolerated Dose (MTD)

WGI-0301 Plus Lenvatinib at MTD

Lenvatinb DRUG

Lenvatinib for patients with body weight of \<60 kg: 8 mg orally daily, for patients with body weight ≥60 kg: 12 mg orally daily

Lenvatinib Only; WGI-0301 Plus Lenvatinib at Dose Level Below MTD; WGI-0301 Plus Lenvatinib at MTD

Eligibility Criteria

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

You may qualify if:

• \. ≥18 years of age on the day of signing informed consent, male or female. 2. 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).
• \. 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. 11. 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})

You may not qualify if:

• \. Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
• \. Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma. 3. 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.
• \. 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).

Sponsors & Collaborators

• Zhejiang Haichang Biotech Co., Ltd.: lead

Central Study Contacts

Angela Men

CONTACT

240-702-0080; angela.men@thewogroup.com

Study Design

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

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share