A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
Trial Parameters
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Brief Summary
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
Eligibility Criteria
Inclusion Criteria: 1. Voluntary participation in this clinical trial, understanding and following the research protocol, and voluntarily signing the Informed Consent Form (ICF). 2. Age ≥18 and ≤75, male or female. 3. Participants with histologically or cytologically confirmed diagnosis of advanced solid tumors who have failed standard therapy or for whom no standard therapy is available. 4. Participants must have at least one measurable lesion according to RECIST Version1.1 5. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 6. Hepatocellular carcinoma patients with Child-Pugh score ≤ 7 7. Expected survival time is at least 3 months 8. Adequate organ function: neutrophil count≥1.5×109/L,platelet count ≥100×109/L,hemoglobin≥90g/L,alanine aminotransferase and aspartate aminotransferase ≤2.5×upper limit of normal (ULN); patients with hepatocellular carcinoma or concomitant hepatic metastases ≤5.0×ULN, total bilirubin ≤1.5×ULN, renal function and cardiopulmonary funct