HC006 plus a PD-1 inhibitor for advanced solid tumors
A Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors:A Multicenter, Open-Label, Dose-Escalation and Multiple Cohort Dose Expansion Phase 1b Clinical Trial
This trial tests whether adding HC006 to a PD-1 inhibitor helps people with advanced solid tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 252 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | HC Biopharma Inc. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06963814 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with histologically confirmed advanced solid tumors, ECOG 0–1, measurable disease by RECIST v1.1, able to provide tumor tissue, and with adequate organ function are eligible.
Not a fit: Patients with only brain lesions as target lesions, ECOG ≥2, very limited life expectancy, or who cannot provide required tissue samples are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, adding HC006 could boost the immune response against tumors and improve outcomes for patients who do not fully respond to PD-1 inhibitors.
How similar studies have performed: Targeting CCR8 to deplete tumor-infiltrating regulatory T cells is a relatively new approach with encouraging preclinical data and limited early clinical signals of synergy with PD-1 blockade but no definitive clinical proof yet.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Shanghai, Shanghai Municipality
- Shanghai East Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Ke Yao, master
- Email: ke.yao@btyy.com
- Phone: 028-85142721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.