OncoMatch/Clinical Trials/NCT07364357
A Phase I Study of CREPT-618 in Locally Advanced HCC
Is NCT07364357 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for hepatocellular carcinoma (hcc).
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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Biomarker criteria
Required: CREPT overexpression (H-score > 50% with a staining intensity of 2+)
confirming both CREPT and ASGPR receptor positivity in liver cancer tissue. Alternatively, a tumor biopsy can be performed to confirm CREPT and ASGPR double positivity. H-score must be greater than 50% with a staining intensity of 2+.
Required: ASGR1 overexpression (H-score > 50% with a staining intensity of 2+)
confirming both CREPT and ASGPR receptor positivity in liver cancer tissue. Alternatively, a tumor biopsy can be performed to confirm CREPT and ASGPR double positivity. H-score must be greater than 50% with a staining intensity of 2+.
Disease stage
Required: Stage BCLC STAGE C
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard treatment
Failed prior standard treatment.
Cannot have received: systemic anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, cytokine therapy, immunotherapy)
Exception: Oral fluoropyrimidine drugs or small molecule targeted agents received more than 2 weeks or 5 half-lives before the first dose (whichever is longer, but not exceeding 28 days); Traditional Chinese medicine for anti-tumor treatment received more than 2 weeks prior to the first dose; Palliative bone-directed radiotherapy
Received systemic anti-tumor therapy (chemotherapy, radiotherapy, biological therapy, cytokine therapy, immunotherapy) or participated in other therapeutic clinical studies within 4 weeks prior to the first dose of the study drug. This includes nitrosourea drugs or mitomycin C within 6 weeks prior to the first dose.
Cannot have received: systemic immunostimulants
Received systemic immunostimulants within 4 weeks or 5 half-lives (whichever is longer) prior to enrollment.
Cannot have received: systemic corticosteroids or other immunosuppressive drugs (prednisone > 10 mg/d or equivalent)
Exception: topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids, or short-term use of corticosteroids for prophylactic purposes
Used systemic corticosteroids (prednisone > 10 mg/d or equivalent dose) or other immunosuppressive drugs within 14 days before the start of study treatment. Exceptions include topical, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids, or short-term use of corticosteroids for prophylactic purposes.
Cannot have received: immunotherapy (anti-CTLA-4, anti-PD-L1)
History of immunotherapy (including anti-CTLA-4/anti-PD-L1 or other agents) with any unresolved irAEs > Grade 1 prior to the first dose, or a history of irAEs ≥ Grade 3.
Lab requirements
Blood counts
Platelets ≥ 70 × 10^9/L; Neutrophils ≥ 1.5 × 10^9/L; Hemoglobin ≥ 90 g/L
Kidney function
Creatinine clearance (Ccr) > 50 ml/min (Cockcroft-Gault formula); Serum creatinine ≤ 1.5 mg/dL (133 μmol/L)
Liver function
Total bilirubin ≤ 3 mg/dL (51.3 μmol/L); Albumin ≥ 2.8 g/dL (28 g/L); INR ≤ 2.3 or prothrombin time prolongation ≤ 6 seconds; ALT or AST ≤ 3 times the upper limit of normal (ALT ≤ 120 U/L, AST ≤ 105 U/L); No severe liver decompensation (see exclusion criteria)
Acceptable major organ function as defined by the following laboratory values: Platelets ≥ 70 × 10^9/L Neutrophils ≥ 1.5 × 10^9/L Hemoglobin ≥ 90 g/L Prothrombin time prolongation ≤ 6 seconds Renal function: Creatinine clearance (Ccr) > 50 ml/min (calculated using the Cockcroft-Gault formula).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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