HC006 plus a PD-1 inhibitor for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multicenter Phase 1b study that gives HC006 together with a PD-1 inhibitor to adults with advanced solid tumors. The trial has a dose-escalation stage to find a recommended dose followed by dose-expansion cohorts in selected tumor types. Primary objectives include safety, tolerability, pharmacokinetics and immunogenicity, with secondary measures of preliminary anti-tumor activity. HC006 is an anti-CCR8 antibody intended to deplete CCR8-positive regulatory T cells and potentially boost PD-1 inhibitor effects.

Why it matters

Who can join: the full rules

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;

Where it's running

• Shanghai East Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Ke Yao, master
• Email: ke.yao@btyy.com
• Phone: 028-85142721

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.