Actively Recruiting
A Study of HC006 in Subjects With Advanced Solid Tumors
Led by HC Biopharma Inc. · Updated on 2025-05-06
76
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies. This study is a first-in-human (FIH) study of HC006 in subjects with advanced solid tumors.
CONDITIONS
Official Title
A Study of HC006 in Subjects With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed advanced solid tumor that is unresectable, metastatic, refractory to, intolerant of, or lacking standard therapy
- At least one measurable disease lesion for expansion cohorts or one assessable lesion for dose escalation
- Agreement to provide archived or fresh tumor tissue samples for expansion cohorts
- Life expectancy of 12 weeks or more
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Adequate organ function as described in the protocol
- Agreement to use effective contraception methods
You will not qualify if you...
- Prior treatment with CCR8 inhibitor or known allergy to any component of HC006
- Systemic anti-cancer therapy within 4 weeks before first dose
- Use of live attenuated vaccines within 28 days
- Presence of primary central nervous system tumors or unstable CNS metastases
- Active or past autoimmune or immunodeficiency diseases
- Active, uncontrolled bacterial, viral, or fungal infections requiring systemic therapy
- Significant mental or cognitive impairments affecting study participation
- Major surgery within 4 weeks before study drug administration
- Uncontrolled or severe illnesses including severe cardiovascular disease, interstitial lung disease, non-infectious pneumonia, or uncontrolled clinical third luminal effusion
- Unresolved adverse events from prior anti-tumor therapy above CTCAE grade 1
- History of other malignancies within 5 years except treated carcinoma in situ of cervix or non-melanoma skin cancer
- Pregnant or breastfeeding women
- Other protocol-defined exclusions may apply
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, 200120
Actively Recruiting
Research Team
L
langxi Zhang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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