OH2 Oncolytic Viral Therapy Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer

NCT05698459 | Recruiting Phase 1

• 1 other identifier: BH-OH2-011
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

An open-label dose-escalation phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of OH2 injection via transcatheter Intraarterial infusion in patients with advanced hepatocellular carcinoma

Conditions

Advanced Liver Cancer

Keywords

Oncolytic Virus

Outcome Measures

Primary Outcomes (2)

• DLTs (Dose Limiting Toxicity)

  Toxic reactions according to the NCI-CTCAE 5.0 grading standard that occur within 3 weeks from the first administration, are judged to be drug-related by the investigator, and meet the non-hematological toxicity and hematological toxicity conditions specified in the clinical protocol

  3 weeks from the first administration

• MTD (Maximum Tolerance dose)

  If ≥2/6 subjects developed DLT, the previous dose group was MTD

  2 years

Secondary Outcomes (7)

• Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)

  2 years

• Objective Response Rate

  2 years

• Disease Control Rate

  2 years

• OS (Overall Survival)

  2 years

• PFS (Progression Free Survival)

  2 years

Study Arms (1)

OH2

EXPERIMENTAL

Administration：intratumoral injection Frequency：once every 3 weeks

Biological: OH2 injection

Interventions

OH2 injection BIOLOGICAL

OH2 injection administered by transcatheter Intraarterial infusion

OH2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have fully understood the study and voluntarily signed the informed consent (the informed consent must be signed before performing any procedure specified in the test);
• Age 18-75 years old (inclusive);
• Patients with primary or metastatic liver cancer confirmed histologically or cytologically;
• Patients with liver cancer who have failed standard treatment, are not suitable for or are not willing to accept standard treatment;
• ECOG physical condition 0 or 1;
• Meet Child-Pugh liver function rating: Grade A or B;
• Adequate bone marrow, liver, kidney and organ functions, meeting the following requirements in laboratory examination within 7 days prior to the first medication (no blood transfusion, blood products, no correction of granulocyte colony stimulating factor or other hematopoietic stimulating factors within 14 days prior to the laboratory examination) :
• Neutrophil absolute count (ANC) ≥1.5×109/L, platelet ≥100×109/L, hemoglobin ≥90g/L;
• Serum total bilirubin ≤3 times the upper limit of the normal reference range (3×ULN);
• Alanine transaminase (ALT) and/or aspartate transaminase (AST) ≤5×ULN;
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL/min (as calculated by Cockcroft-Gault formula);
• International Normalized ratio (INR) ≤1.5 or partially activated prothrombin time (APTT) ≤1.5×ULN;
• Subjects with chronic HBV infection must receive HBV-DNA \< 500IU/ml and HBsAg positive patients must receive antiviral therapy according to the Guidelines for Chronic Hepatitis B Prevention and Treatment 2015 Edition. HCV-RNA positive patients must receive antiviral therapy according to the Hepatitis C Prevention and Treatment Guidelines 2015 Edition and have liver function within the normal range;
• Recovery of AE associated with previous systemic chemotherapy, radical/extensive radiotherapy to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) ≤ Class 1 (except hair loss, non-clinically significant and asymptomatic laboratory abnormalities);
• For subjects with herpes, 3 months after completion of herpes treatment;

You may not qualify if:

• A history of pleural effusion related to moderate or severe ascites, hemorrhagic esophageal varices, hepatic encephalopathy, or liver insufficiency within 6 months prior to screening;
• Patients with large tumors - tumors \>50% by liver volume and/or invading inferior vena cava;
• Non-recovery to National Cancer Institute General Adverse Event Term 5.0 (NCI CTCAE V5.0) level 1 toxicity (excluding hair loss, non-clinically significant and asymptomatic laboratory abnormalities) due to prior antitumor therapy prior to initial administration of the study drug;
• Other malignancies (except basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix that have been effectively controlled) in the past 5 years;
• For subjects with known central nervous system metastases, if they have received BMS in the past and their condition is stable (no evidence of imaging progression is seen at least 4 weeks before the first administration of the trial therapy, and any neurological symptoms have returned to baseline), repeated imaging examinations confirm no evidence of new BMS or the expansion of the original BMS. Participants who do not require steroid therapy at least 14 days before the initial administration of the trial therapy are eligible to participate in the trial. Subjects with cancerous meningitis should be excluded regardless of whether they are clinically stable;
• Received standard anti-tumor therapy for liver cancer within 4 weeks before the first drug use, including surgery, interventional therapy, systemic therapy, radiotherapy and traditional Chinese medicine therapy (the instructions for traditional Chinese medicine therapy with clear anti-tumor indications, and a one-week washout period is enough before the first drug use);
• Received radical radiotherapy (including more than 25% bone marrow radiotherapy) within 4 weeks prior to initial medication;
• Have previously received similar drugs for antitumor therapy;
• Received major surgical operations (the definitions of major surgical operations refer to Grade 3 and Grade 4 operations specified in the "Measures for the Clinical Application of Medical Technology" implemented on May 1, 2009) or unhealed wounds, ulcers and fractures within 4 weeks before the first drug use;
• The subjects currently have active gastric and duodenal ulcers, ulcerative colitis and other digestive tract diseases, or active bleeding from unexcised tumors, or other conditions determined by the researchers that may cause digestive tract bleeding and perforation;
• Patients with significant evidence or history of bleeding tendency within 2 months prior to initial medication (bleeding \>30mL within 2 months, hematemesis, black feces, and hematochezia), hemoptysis (\>5mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attacks) within 12 months;
• Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to initial medication; New York Heart Association (NYHA) Grade \>2 for congestive heart failure; Left ventricular ejection fraction (LVEF) \<50%; Primary cardiomyopathy, a history of clinically significant prolonged QTc interval, or QTc interval \>470ms in women and \>450ms in men during the screening period;
• Severe and uncorrectable electrolyte abnormalities determined by the investigator to be clinically significant;
• The patient had an active infection or developed an unexplained fever (body temperature \>38.5oC) during screening and prior to initial administration;
• Preparing for or having previously received allogeneic organ or bone marrow transplantation, including liver transplantation;

Sponsors & Collaborators

• Binhui Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430000, China

RECRUITING

Central Study Contacts

chuansheng zheng, MD

CONTACT

13329702158; 13329702158@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: May 5, 2023
• Primary Completion: August 1, 2025
• Study Completion: January 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Locations

CN (1)