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Advanced Liver CancerPhase 1NCT05698459

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

A Phase 1 study testing OH2 injection in people with Advanced Liver Cancer, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Liver Cancer
What is being tested?
OH2 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
5 May 2023to Jan 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • Expected survival ≥12 weeks;
  • Fertile women must have a negative serum or urine pregnancy test within 7 days before the first dose. Fertile male or female patients volunteered to use effective contraceptive methods, such as dual screen contraception, condoms, oral or injectable contraceptives, and intrauterine devices, during the study period and within 90 days of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization (e.g. hysterectomy, bilateral adnexectomy or irradiation of radioactive ovaries).
  • More than 4 weeks after the end of previous anti-tumor therapy (including endocrine, chemical/radiotherapy, targeted therapy) (more than 6 weeks after the treatment of nitrosourea and mitomycin chemotherapy);
  • Four weeks after major surgery;
  • At least one measurable or evaluable lesion was present according to RECIST1.1 criteria.

Who cannot join

  • 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);
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  • 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;
  • Subjects with a past or current history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, or severe impairment of lung function that might interfere with the detection and management of suspected drug-related pulmonary toxicity;
  • Patients with active tuberculosis (TB) who are receiving anti-TB therapy or have received anti-TB therapy within 1 year prior to initial medication; Known human immunodeficiency virus (HIV) infection; The copy number of hepatitis B and hepatitis C virus was active.
  • Pregnant women (positive pregnancy test before medication) or breastfeeding women;
  • Known allergy to any herpes virus and OH2 inJ ingredients;
  • Any other medical condition, clinically significant metabolic abnormality (e.g., uncontrolled diabetes, thyroid dysfunction), physical abnormality, or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition unsuitable for the study drug (e.g., the presence of epileptic seizures and the need for treatment), Or it could affect the interpretation of the findings, or put patients at high risk.
  • Received the corresponding experimental drugs in clinical trials of other unapproved or unmarketed drugs within 4 weeks before the first drug use;
  • As determined by the investigator, the subjects had other factors that might have led to the forced termination of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

chuansheng zheng, MD contact

13329702158

13329702158@163.com

China1 site, 1 recruiting

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

    Wuhan, Hubei, 430000

    Chuansheng Zheng, MD

    Recruiting

Other trials in China

About this study

Official title: A Phase I, Open-label, Dose Escalation Study to Evaluate the Safety ,tolerance and Pharmacokinetics of OH2 Via Transcatheter Intraarterial Infusion in Patients with Advanced Liver Cancer

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

Being tested
OH2 injection
Keywords
Oncolytic Virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OH2 injectionBiological

    OH2 injection administered by transcatheter Intraarterial infusion

Study groups in NCT05698459
Study groupRoleWhat they receive
OH2ExperimentalAdministration：intratumoral injection Frequency：once every 3 weeks
Receives: Biological: OH2 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 weeks from the first administration

  2. MTD (Maximum Tolerance dose)

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

    Measured: 2 years

Secondary outcomes (7)

  1. Incidence of AE (Adverse Event) and SAE (Serious Adverse Event)

    According to the NCI-CTCAE 5.0 grading standard

    Measured: 2 years

  2. Objective Response Rate

    The assessment result is the number and proportion of subjects with complete response + partial response.

    Measured: 2 years

  3. Disease Control Rate

    The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.

    Measured: 2 years

  4. OS (Overall Survival)

    The overall survival for each patient receiving OH2 will be calculated.

    Measured: 2 years

  5. PFS (Progression Free Survival)

    Time after OH2 administration to clinical and radiographic disease progression will be evaluated.

    Measured: 2 years

  6. Biodistribution and viral shedding

    OH2 DNA copy

    Measured: 2 years

  7. Immunogenicity

    HSV-2 antibody

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start5 May 2023
  3. Primary completionAug 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698459
Sponsor's protocol ID
BH-OH2-011
Status last verified
Dec 2024
First submitted
16 Jan 2023
Last updated
20 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OH2 injection in people with Advanced Liver Cancer, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact chuansheng zheng, MD (13329702158, 13329702158@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (Dose Limiting Toxicity) (time frame: 3 weeks from the first administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.

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