Status:
RECRUITING
Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
Lead Sponsor:
HC Biopharma Inc.
Conditions:
Advanced Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is an open-label, multicenter Phase 1b clinical study to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and preliminary efficacy of HC006 in combination with a PD-1 inhibitor...
Detailed Description
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 immu...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
July 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06963814
Start Date
July 4 2025
End Date
May 30 2027
Last Update
July 17 2025
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123