Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC (NCT07540832) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase 2 Study of WGI-0301 Plus Lenvatinib in Patients With Advanced HCC
80 participantsStarted 2026-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1\. ≥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.
3\. Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per AASLD criteria.
4\. 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).
5\. 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.
6\. 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).
7\. Eligible for treatment with Lenvatinib, as determined by investigators according to the Package Inser…
What they're measuring
1
Efficacy of WGI-0301 in Combination with Lenvatinib