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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
WGI-0301
DrugWGI-0301 at Maximum Tolerated Dose (MTD)
Nivolumab (240 mg)
DrugNivolumab is given as an intravenous infusion, every 2 weeks
WGI-0301
DrugWGI-0301 at dose level below Maximum Tolerated Dose (MTD-1)
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Efficacy of WGI-0301 in Combination with Nivolumab
Efficacy will be assessed via Objective Response Rate (ORR), as determined by investigator using RECIST 1.1.
Secondary outcomes
Safety and tolerability of WGI-0301 in combination with Nivolumab
Determined by number of AEs, SAEs
Peak Plasma Concentration (Cmax)
Drug Concentration in the boold will be used to determine Peak Plasma Concentration (Cmax)
Tmax (Time to peak drug concentration)
Drug Concentration in the boold will be used to determine Tmax (Time to peak drug concentration)
Area under the Curve (AUC)
Drug Concentration in the boold will be used to determine Area under the Curve (AUC)
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: