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

ConditionAdvanced Hepatocellular Carcinoma (HCC)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Haichang Biotech Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

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 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.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • WGI-0301

    Drug

    WGI-0301 at Maximum Tolerated Dose (MTD)

  • WGI-0301

    Drug

    WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1)

  • 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

Treatment groups

80 Participants
are divided into 3 treatment groups
Group A: WGI-0301 Plus Lenvatinib at MTDExperimental treatment 2 interventions
Group B: WGI-0301 Plus Lenvatinib at Dose Level Below MTDExperimental treatment 2 interventions
Group C: Lenvatinib OnlyActive comparator 1 intervention

Trial outcomes

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.

Time frame
24 months

Secondary outcomes

1

Safety and tolerability of WGI-0301 in combination with Lenvatinib

Determined by number of AEs, SAEs

Time frame
24 months
2

Peak Plasma Concentration (Cmax)

Drug Concentration in the boold will be used to determine Peak Plasma Concentration (Cmax)

Time frame
28 days
3

Tmax (Time to peak drug concentration)

Drug Concentration in the boold will be used to determine Tmax (Time to peak drug concentration)

Time frame
28 days
4

Area under the Curve (AUC)

Drug Concentration in the boold will be used to determine Area under the Curve (AUC)

Time frame
28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang Haichang Biotech Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: