Single Arm Clinical Study Protocol of GV20-0251 in the Treatment of Advanced/Refractory Solid Tumors

Standard Phase I clinical trial (dose escalation test) 3 + 3 study method was used: the initial dose group 1 was 10 mg/kg (Q3W) and 20 mg/kg (Q3W) for dose group 2. If the MDT is not reached at dose group 2, no further dose escalation will be conducted. Three individuals were enrolled first at each dose level. If none of the three patients developed DLT during treatment (DLT observation period of 21 days), the trial entered the next dose group. Otherwise, when 1 out of 3 subjects experiences DLT, an additional 3 subjects should be enrolled in this dose group. If only 1 out of 6 patients experienced DLT, the trial continued to the next dose level. If ≥ 2 out of 3 or ≥ 2 out of 6 patients experience a DLT, enrollment will not continue to increase. If the first 3 participants cannot tolerate this dose level, a lower dose or regimen may be used after approval by the site's Clinical Trial Committee. The following oncologic indications will be assessed in this study: hepatocellular carcinoma (HCC), cholangiocarcinoma, uveal melanoma, non-uveal melanoma, non-small cell lung cancer (NSCLC), pancreatic ductal adenocarcinoma, head and neck squamous cell carcinoma (HNSCC), endometrial cancer, and testicular cancer. Additional indications may be evaluated, including CRC, clear cell renal cell carcinoma, gastric or gastroesophageal junction carcinoma, sarcoma carcinoma, breast cancer, prostate cancer, cervical cancer, and small cell lung cancer. (The method of drug infusion and detailed drug-related instructions are provided in the Annex of the Investigational Drug Instruction Manual).

Screening period:

1. From the day the subject signed the informed consent form to the day before the first dose of the investigational product (Day 1),
2. The screening period does not exceed 28 days (Day-28 to Day-1);

Treatment Period and Efficacy Evaluation:

Eligible participants entered the treatment phase, and the investigator calculated the administered dose and drug concentration of GV20-0251 based on the patient's body weight, thereby calculating the required GV20-0251 drug volume and the corresponding number of bottles. The study nurse will remove the bottle from the refrigerator and bring it to room temperature, which will take approximately 30-60 minutes. GV20-0251 solution for intravenous infusion is formulated from GV20-0251 injection and 0.9% sodium chloride injection in a saline bag volume of 250 mL depending on the amount of GV20-0251 injection administered. GV20-0251 Injection will be administered to eligible subjects by a research nurse under the supervision of study personnel.