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
This trial does not accept healthy volunteersQualifiers
≥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
Design model
Sequential
Treatments tested in this trial
WGI-0301 at MTD/RP2D dose IV infusion, QW
DrugWGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC.
WGI-0301 at MTD/RP2D -1 dose IV infusion, QW
DrugWGI-0301 is a lipid nanoparticle preparation of Archexin®, a 20-mer oligonucleotide that is complementary to Akt-1 mRNA, formulated for the treatment of advanced HCC.
Sorafenib 400 mg PO, BID continuously
DrugSorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma.
Sorafenib 400 mg PO, BID
DrugSorafenib is an oral multi-kinase inhibitor used for the treatment of hepatocellular carcinoma.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: Arm AExperimental treatment 2 interventions
Group B: Arm BExperimental treatment 2 interventions
Group C: Arm CActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of WGI-0301 in combination with Sorafenib based on ORR per RECIST 1.1.
ORR is defined as the percentage of patients documented to have a confirmed CR or PR.
Time frame
through study completion, an average of 2 yearSecondary outcomes
1
Safety of each dose group.
Determined by number of AEs, SAEs, number of participant with changes in safety relevant clinical parameters, number of participants with dose modifications.
Time frame
through study completion, an average of 2 year2
Tolerability of each dose group.
Determined by number of AEs, SAEs, number of participant with changes in safety relevant clinical parameters, number of participants with dose modifications.
Time frame
through study completion, an average of 2 year3
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on ORR.
ORR is defined as the percentage of patients documented to have a confirmed CR or PR.
Time frame
through study completion, an average of 2 year4
Anti-tumor activity if WGI-0301 in combination with Sorafenib based on DCR.
DCR is defined as the percentage of patients documented to have a confirmed CR or PR or SD.
Time frame
through study completion, an average of 2 yearSponsors and contacts
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Source ClinicalTrials.gov