Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors

HC006 is an IgG1 monoclonal antibody targeting CCR8, which can specifically clear CCR8-positive tumor infiltrating Treg cells without affecting CD8+ T cell function, thus enhancing the anti-tumor immune response. It has a synergistic effect on anti-tumor effects when combined with PD-1 inhibitors. Based on the existing evidence-based medicine, HC006 combined with PD-1 inhibitors is expected to provide additional treatment benefits in addition to PD-1 inhibitors for a variety of malignant solid tumors including colorectal cancer, head and neck squamous cell carcinoma, gastric cancer, non-small cell lung cancer, cervical cancer, breast cancer, esophageal cancer, pancreatic cancer, ovarian cancer, melanoma, urothelial cancer and renal cancer.

Inclusion criteria

• Fully understand this trial and voluntarily sign the informed consent form;
• Advanced solid tumors diagnosed by histology or cytopathology;
• Be able to provide archived (within 2 years after the first treatment with study drug) or fresh tumor tissue samples for relevant biological sample analysis required by the protocol;
• At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
• Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;
• The expected survival time is more than 3 months;
• Adequate organ and bone marrow function
• Females of childbearing potential must have a negative blood pregnancy test within 7 days prior to the first dose of investigational product and be non-lactating; Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception (hormonal or barrier method or abstinence) with their partner for at least 6 months from signing informed consent until after the last dose of study drug. Women of non-childbearing potential may not undergo pregnancy test and contraception (postmenopausal for at least 1 year or surgically sterilized).

Exclusion criteria

• Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
• Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
• Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
• Conditions may significantly affect the autoimmune status;
• Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:
• Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;
• Subjects who have undergone major organ surgery (excluding aspiration biopsy) within 4 weeks prior to the first dose of study drug, or have experienced significant trauma, or require elective surgery during the trial;