Actively Recruiting
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
Led by HC Biopharma Inc. · Updated on 2025-05-13
122
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This clinical trial is a multicenter, open, single-arm, non-randomized, dose-escalation and dose-expansion, phase I clinical study in patients with advanced recurrent or metastatic solid tumors.The goal of this study is to evaluate the safety and tolerability of HC010 monotherapy in patients with advanced solid tumors.
CONDITIONS
Official Title
A Phase I Study to Evaluate the Safety, Pharmacokinetics and Antitumor Activity of HC010 in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years, male or female
- Confirmed diagnosis of advanced solid tumors with failed or no standard therapy
- Have at least one measurable tumor lesion as defined by RECIST 1.1
- ECOG Performance Score of 0 or 1
- For hepatocellular carcinoma patients, Child-Pugh score ≤ 7
- Expected survival time of at least 3 months
- Adequate organ function with specified blood counts and liver, kidney, and heart function
- Provide fresh or archived tumor tissue sample for biomarker analysis when possible
- Agree to use effective contraception if of childbearing potential; females must have negative pregnancy test within 7 days prior to first dose
You will not qualify if you...
- Received chemotherapy, radiotherapy, or other systemic treatments within 28 days or 5 half-lives before first dose
- Taken herbal or proprietary Chinese medicines with anti-tumor effects within 2 weeks before first dose
- Undergone surgery or experienced severe trauma within 4 weeks before first dose
- Used systemic glucocorticoids or immunosuppressive agents within 2 weeks before first dose
- Used immunomodulatory drugs within 2 weeks before first dose
- Received live attenuated vaccines within 4 weeks before first dose
- Prior treatment with anti-PD-1/PD-L1, anti-CTLA-4, or anti-VEGF therapies
- Unresolved toxicities from prior cancer treatments above grade 1
- History of immune-related adverse events causing permanent discontinuation or severe toxicity from prior therapies
- Previous allogeneic stem cell or organ transplantation
- Active brain metastases, meningeal metastases, spinal cord compression, or molluscum contagiosum disease
- Other malignancies within 5 years except certain treated skin or thyroid cancers
- Active or history of autoimmune disease
- Active infections including hepatitis B/C, HIV/AIDS, syphilis, tuberculosis, or active infections within 2 weeks
- Unstable systemic diseases such as severe cardiovascular disease or effusions needing drainage
- Severe bleeding or clotting disorders
- History of non-infectious pneumonia or interstitial lung disease requiring steroids
- Pregnant or breastfeeding females
- Any condition deemed inappropriate for the study by the investigator
- Known allergy or severe reaction to components of HC010
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
L
Langxi Zhang, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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