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

Launched by HC BIOPHARMA INC. · Apr 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called HC006 combined with another medication known as a PD-1 inhibitor for patients with advanced solid tumors, which are types of cancer that have spread beyond their original location. The trial aims to find out how safe this combination is, how well the body tolerates it, and whether it might help treat cancer. It is divided into two parts: first, researchers will test different doses to find the best one, and then they will treat more patients with that dose to see how effective it is.

To participate in this trial, patients need to be between 18 and 75 years old and have been diagnosed with advanced solid tumors. They must be able to provide a tissue sample from their tumor and have at least one measurable cancer lesion. Additionally, patients should be in relatively good health, with expected survival of more than three months. It's important to note that certain conditions, like having active brain metastasis (cancer spread to the brain) or recent major surgeries, may exclude someone from participating. If eligible, participants will receive the study drug and will be closely monitored for any side effects or benefits during the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fully understand this trial and voluntarily sign the informed consent form;
• • 2. Advanced solid tumors diagnosed by histology or cytopathology;
• • 3. 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;
• • 4. At least one measurable lesion according to RECIST Version 1.1 (patients with only brain lesion as target lesion are not accepted);
• • 5. Eastern United States Oncology Assistance Group (ECOG) performance status score of 0 or 1;
• • 6. The expected survival time is more than 3 months;
• • 7. Adequate organ and bone marrow function
• • 8. 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:
• • 1. Patients with imaging findings showing tumor invasion of great vessels or unclear demarcation from blood vessels;
• • 2. Patients with combined brain metastasis, meningeal metastasis, spinal cord compression or leptomeningeal disease;
• • 3. Previous treatment with monoclonal antibodies, bispecific antibodies, small molecule compounds and cells targeting CCR8 at any time;
• • 4. Conditions may significantly affect the autoimmune status;
• 5. Patients with serious, uncontrolled and unrecoverable acute and chronic diseases:
• • 6. Subjects with other malignant tumors within 5 years prior to the first dose of the investigational drug ;
• • 7. 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;