Actively Recruiting
An Open-label Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-tumor Activity of CREPT-618 in Patients With Locally Advanced Hepatocellular Carcinoma
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2026-01-23
13
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and appropriate dosing of CREPT-618 in adults aged 18 to 75 with locally advanced hepatocellular carcinoma who have not responded to standard treatments. This Phase I clinical study uses a dose-escalation design to determine the maximum tolerated dose, optimal biological dose, and recommended dose for future studies, while also assessing pharmacokinetics and preliminary efficacy. The study involves three main dose groups: low (0.5 mg/kg), medium (1.5 mg/kg), and high (4.5 mg/kg). Patients receive single or multiple subcutaneous injections of CREPT-618 every two weeks. Starting with one sentinel patient in the low-dose group observed for 28 days, the trial progresses to higher doses based on safety and absence of dose-limiting toxicities. If tolerated, the dose may be increased to 9 mg/kg with additional patient enrollment. Disease progression after six weeks may lead to combination treatment with pembrolizumab. Participants will undergo safety evaluations, pharmacokinetic sampling at multiple time points after dosing, and efficacy assessments for up to two years. Researchers will monitor adverse events, drug levels in the blood, and early signs of anti-tumor activity. Follow-up includes checking liver function and patient compliance, with treatment adjustments made as needed based on safety and response.
CONDITIONS
Brief 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.
- Ability to understand and voluntarily sign informed consent.
- Failed prior standard treatment for hepatocellular carcinoma.
- ECOG performance status score of 0-2.
- At least one measurable lesion according to RECIST 1.1.
- Ability to provide at least six unstained slides or tumor biopsy confirming CREPT and ASGPR receptor positivity with H-score > 50% and staining intensity 2+.
- Acceptable major organ function as defined by specified lab values, including platelets, neutrophils, hemoglobin, prothrombin time, renal function.
- Expected life expectancy of at least 3 months.
- Use of effective contraception during the study and for at least 6 months after last dose for patients of childbearing potential.
- Negative serum pregnancy test within 7 days prior to enrollment for females of childbearing potential.
- Willingness to comply with study procedures and follow-up.
You will not qualify if you...
- Received systemic anti-tumor therapy or participated in other therapeutic clinical studies within 4 weeks prior to first dose, with exceptions for some oral drugs and traditional Chinese medicine.
- Planned major surgery within 28 days before study treatment.
- Use of systemic immunostimulants within 4 weeks prior to enrollment.
- Use of systemic corticosteroids or immunosuppressive drugs within 14 days before treatment, except certain forms.
- Active autoimmune disease or history within past 2 years, except certain stable conditions.
- Severe liver decompensation symptoms or abnormal liver function tests.
- Positive for HIV or known AIDS.
- Positive for Hepatitis C virus.
- Severe pulmonary disease or oxygen saturation below 93%.
- Unresolved toxicities from prior cancer treatments above Grade 1, except some exceptions.
- Uncontrolled diabetes or severe cardiovascular disease.
- Symptomatic active brain or meningeal metastases or unstable CNS disease.
- Other active malignancies within 5 years, except certain specified cancers.
- Received live attenuated vaccines within 28 days prior to first dose.
- History of immunotherapy with unresolved immune-related adverse events or allergy to CREPT-618.
- Recent liver transplant evaluation or planned transplant.
- Mental disorder or poor compliance.
- Known alcohol or drug abuse.
- Pregnant or lactating females.
- Other severe illness or abnormal lab findings making patient unsuitable as per investigator discretion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive subcutaneous injections of CREPT-618 at escalating doses every two weeks. The treatment includes dose escalation from low to high dose groups, with safety and pharmacokinetic assessments. Dose adjustments and combination with pembrolizumab may occur depending on disease progression and safety evaluations.
Injections every two weeks with multiple safety and pharmacokinetic assessments including baseline and post-dose sampling
Duration - Up to about 2 years
Participants are monitored for safety, pharmacodynamics, and preliminary efficacy following the treatment period. This includes assessments for up to about 2 years to evaluate long-term outcomes.
Periodic visits for safety and efficacy evaluations
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.
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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