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

NCT07494435 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2026-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Hepato Cellular Carcinoma (HCC)
  • Renal Cell Cancer

Interventions

DRUG

WGI-0301

WGI-0301 at Maximum Tolerated Dose (MTD)

DRUG

Nivolumab (240 mg)

Nivolumab is given as an intravenous infusion, every 2 weeks

DRUG

WGI-0301

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

Sponsors & Collaborators

  • Zhejiang Haichang Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2028-09-01
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494435 on ClinicalTrials.gov