Actively Recruiting
A Phase I Study of CREPT-618 in Locally Advanced HCC
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-23
13
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single-center, open-label, dose-escalation Phase I clinical study designed to evaluate the safety (incidence of adverse events), maximum tolerated dose (MTD), optimal biological dose (OBD), and recommended Phase II dose (RP2D) of CREPT-618 in adult patients aged 18-75 with locally advanced hepatocellular carcinoma who have failed standard treatment. The study adopts a 3+3 dose escalation design for dose climbing, primarily consisting of three dose groups: low dose, medium dose, and high dose. Patient enrollment and dose escalation in each group will be based on safety evaluation results. Pharmacokinetic parameters and preliminary efficacy indicators will also be assessed.
CONDITIONS
Official Title
A Phase I Study of CREPT-618 in Locally Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years
- Histologically confirmed locally advanced hepatocellular carcinoma (BCLC stage C or ineligible for curative treatment)
- Inactive hepatitis B infection with negative HBV-DNA viral load
- Able to understand and voluntarily sign informed consent
- Failed prior standard treatment
- ECOG performance status of 0 to 2
- At least one measurable lesion according to RECIST 1.1
- Able to provide liver cancer tissue samples positive for CREPT and ASGPR receptors (H-score > 50%, staining intensity 2+)
- Acceptable major organ function based on specified laboratory values
- Life expectancy of at least 3 months
- Agree to use effective contraception during the study and for 6 months after last dose (if of childbearing potential)
- Negative pregnancy test within 7 days prior to enrollment (for females of childbearing potential)
- Willing and able to comply with follow-up procedures
You will not qualify if you...
- Received systemic anti-tumor therapy or participated in other therapeutic clinical studies within 4 weeks prior to study drug start (with some exceptions)
- Planned major surgery within 28 days before treatment start (diagnostic biopsies allowed)
- Received systemic immunostimulants within 4 weeks prior to enrollment
- Used systemic corticosteroids or immunosuppressive drugs within 14 days before treatment (with specified exceptions)
- Active autoimmune disease or history within past 2 years (some exceptions)
- Severe liver decompensation symptoms or complications
- Abnormal laboratory values exceeding specified limits
- Severe infections or comorbidities including HIV, hepatitis C, pulmonary diseases
- Unresolved toxicities from prior cancer treatments above Grade 1 (few exceptions)
- Uncontrolled diabetes or severe cardiovascular disease
- Symptomatic active brain or meningeal metastases or untreated CNS tumors
- History of other active malignancies within 5 years (some exceptions)
- Received live attenuated vaccines within 28 days before study drug start
- History of immunotherapy with unresolved immune-related adverse events or known allergy to CREPT-618
- Planned liver transplant evaluation or transplant within 4 weeks prior or during study
- Mental disorders or poor compliance
- History of alcohol or drug abuse
- Pregnant or lactating females
- Any other severe physical or mental illness or abnormal labs deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
P
Peiwen Ma, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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