Phase 2 Study of WGI-0301 for Advanced HCC
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Haichang Biotech Co., Ltd.
About this trial
The purpose of this study is to determine the MTD of WGI-0301 in combination with Sorafenib for advanced Hepatocellular Carcinoma (HCC) and assess its safety and efficacy in adults with advanced unresectable HCC who have previously received PD-1 / PD-L1 immune checkpoint inhibitors.
Eligibility criteria
Qualifiers
≥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 2018 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).
Disqualifiers
Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study.
Stage 2 and Stage 3: 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.
Trial design
Treatments tested in this trial
- WGI-0301 at MTD/RP2D dose IV infusion, QW
- WGI-0301 at MTD/RP2D -1 dose IV infusion, QW
- Sorafenib 400 mg PO, BID continuously
- Sorafenib 400 mg PO, BID
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov