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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
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 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.

Eligibility criteria

Qualifiers

1) Age 18-75 (inclusive) on the day of singing informed consent, male or female.

Histologically or cytologically confirmed diagnosis of HCC, or clinical diagnosis of HCC as per American Association for the Study of Liver Diseases (AASLD) criteria

4. Barcelona Clinic Liver Cancer (BCLC) Stage C, or BCLC Stage B that is not suitable for any curative surgeries or locoregional therapy

Child-Pugh Liver Function Class A or Class B (score ≤ 7)

Disqualifiers

1) Pregnant or breastfeeding patients or expecting to conceive or father children within the projected duration of the study 2) For the HCC Cohort, any of the following criteria:

Locoregional therapy to liver within 4 weeks prior to the first dose, including but not limited to TACE, radiotherapy, radiofrequency ablation, microwave (except palliative radiotherapy for bone pain relief completed at least 2 weeks prior to the first dose).

Fibrolamellar carcinoma, sarcomatoid hepatocellular carcinoma or mixed hepatocellular cholangiocarcinoma;

3. 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) 3) Major surgery within 4 weeks prior to the first dose of study intervention. 4) Currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to the first dose of study intervention (except for observational clinical trials) 5) Small molecule targeted therapy and traditional Chinese medicine with antitumor indications received within 2 weeks prior to the first dose, or chemotherapy, biological therapy, and other antitumor treatments received within 4 weeks prior to the first dose 6) Received systemic corticosteroid (prednisone >10mg/day or equivalent) or other immunosuppressive agents within 2 weeks prior to the first dose of study intervention. Inhale or local corticosteroid, or pre-medications for infusion-related reactions/ hypersensitivity is allowed.

Trial design

Treatments tested in this trial

  • WGI-0301
  • Nivolumab (240 mg)
  • WGI-0301

Treatment groups

230 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.