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

Part of paid clinical trials in New York, New York.

Sponsor
Zhejiang Haichang Biotech Co., Ltd.
Study ID
NCT07540832
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Hepatocellular Carcinoma (HCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

First listed
Apr 20, 2026
Start date
Sep 30, 2026
Status verified
Apr 2026
Primary completion
Sep 30, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: WGI-0301 Plus Lenvatinib at MTD
  • Experimental: WGI-0301 Plus Lenvatinib at Dose Level Below MTD
  • Active Comparator: Lenvatinib Only

Primary Outcome Measure

Efficacy of WGI-0301 in Combination with Lenvatinib [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

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Memorial Sloan Kettering Cancer Center· New York, NY