Phase 2 Study of WGI-0301 Plus Nivolumab in Patients With HCC and RCC

Sponsor
Zhejiang Haichang Biotech Co., Ltd.
Study ID
NCT07494435
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hepato Cellular Carcinoma (HCC)
  • Renal Cell Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • WGI-0301 — DRUG
    WGI-0301 at Maximum Tolerated Dose (MTD)
  • Nivolumab (240 mg) — DRUG
    Nivolumab is given as an intravenous infusion, every 2 weeks
  • WGI-0301 — DRUG
    WGI-0301 at dose level below Maximum Tolerated Dose (MTD-1)

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 nivolumab, how the body processes and responds to WGI-0301, and whether this combination shows early signs of working in people with advanced liver cancer or advanced kidney cancer.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Sep 1, 2028

Study Design

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

Arms

  • Experimental: HCC High Dose
  • Experimental: HCC Low Dose
  • Experimental: ccRCC High Dose
  • Experimental: ccRCC Low Dose
  • Experimental: nccRCC High Dose
  • Experimental: nccRCC Low Dose

Primary Outcome Measure

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

Central Contacts

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