Actively Recruiting
Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
Led by HC Biopharma Inc. · Updated on 2025-07-17
252
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 in patients with advanced solid tumors. The trial is divided into two stages: dose-escalation and dose expansion. First, the dose-escalation study is completed to determine the recommended dose for subsequent extension studies, and then the dose expansion study is conducted in the proposed tumors with potential treatment benefits.
CONDITIONS
Official Title
Study of HC006 in Combination With a PD-1 Inhibitor in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand this trial and voluntarily sign the informed consent form
- Diagnosed with advanced solid tumors by histology or cytopathology
- Able to provide archived (within 2 years) or fresh tumor tissue samples for biological analysis
- Have at least one measurable lesion according to RECIST Version 1.1 (excluding only brain lesions)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Expected survival time of more than 3 months
- Adequate organ and bone marrow function
- Females of childbearing potential must have a negative pregnancy test within 7 days before first dose and be non-lactating
- Patients of childbearing potential must agree to use reliable contraception from consent until after last dose
- Women of non-childbearing potential (postmenopausal for at least 1 year or surgically sterilized) may not require pregnancy test or contraception
You will not qualify if you...
- Tumor invasion of major blood vessels or unclear boundaries from blood vessels on imaging
- Presence of brain metastasis, meningeal metastasis, spinal cord compression, or leptomeningeal disease
- Prior treatment with monoclonal antibodies, bispecific antibodies, small molecules, or cells targeting CCR8
- Conditions significantly affecting autoimmune status
- Serious, uncontrolled, and unrecoverable acute or chronic diseases
- Other malignant tumors within 5 years before first dose
- Major organ surgery (excluding biopsy) within 4 weeks before first dose, significant trauma, or need for elective surgery during the trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200123
Actively Recruiting
Research Team
K
Ke Yao, master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here