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Pancreatic CancerPhase 1/2NCT04637698

OH2 Oncolytic Viral Therapy in Pancreatic Cancer

A Phase 1/2 study testing OH2 injection in people with Pancreatic Cancer, run by Binhui Biopharmaceutical Co., Ltd. at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This phase Ib/II study evaluates the safety and efficacy of OH2 in patients with locally advanced/metastatic pancreatic cancer who have failed first-line standard treatment. OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic 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
5 participants
Where
1 siteChina
Study dates
2 Feb 2021to 4 May 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • The non-operative stage III or stage IV locally advanced or metastatic pancreatic cancer patients with clear diagnosis by pathology and/ or cytology.
  • Life expectancy >3 months.
  • Have received at least first-line or more systemic chemotherapy and failed. The definition of failure: Receiving first-line systemic chemotherapy means having used first-line chemotherapy such as gemcitabine, or tigeo capsule, or albumin paclitaxel, or liposomal irinotecan, or FOLFINOX.During or after treatment, the disease progression or toxic side effects are intolerable, and there must be imaging evidence or clinical evidence to prove the disease progression. For neoadjuvant/adjuvant therapy (chemotherapy or radiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, it should be counted as a failure of first-line treatment;
  • Prior anti-tumor treatment including systemic, radical/extensive radiotherapy, targeted therapy, immunotherapy was over 28 days;
  • According to RECIST version 1.1, there is at least one measurable lesion that is suitable for intratumoral injection. The measured non-nodular lesions is defined as the longest diameter ≥ 10 mm . For lymph node lesions, the short diameter is ≥ 15 mm.If the measurable lesions located in the radiation field of previous radiotherapy or after local treatment are confirmed to have progressed, they can also be selected as target lesions.
  • General physical condition score ECOG 0 ≤ 2 (including boundary value);
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  • a) Blood routine: ANC≥1.5×10^9/L, PLT≥80×10^9/L, Hb≥9.0 g/dL.Note: 14 days before the examination, it is not allowed to use any blood components, cell growth factors and other interventions to make the indicators reach the normal range；b) Liver function: TBIL≤ 1.5 times the upper limit of the normal value, ALB≥30 g/L, ALT and AST ≤ 2.5 times the upper limit of normal value; The value of patients with liver metastasis did not exceed 5 times the upper limit of normal value.; c) Renal function: Scr≤1.5 times the upper limit of the normal value,Ccr≥50mL/min (Cockcroft-Gault); d) Coagulation function is normal (PT and APPT are within 1.5 times of the upper limit of normal value);
  • Women of childbearing age had a negative pregnancy test result within 7 days before enrollment. Female subjects and their spouses received effective contraceptives during and within 6 months of treatment；
  • Weight≥40 kg；
  • Subjects with herpes in the reproductive organs needed three months after the end of herpes.
  • The informed consent was voluntarily signed and the expected compliance was good.

Who cannot join

  • Patients diagnosed with pancreatic cancer without pathology and/ or cytology;
  • The target lesion has received local non-drug therapy (including radiotherapy, physical and/or chemical ablation, etc.), and no imaging disease progression has occurred；
  • Central nervous system metastasis or cancerous meningitis is known to occur. For suspected central nervous system metastasis, head MRI examination is required;
  • Patients with Vater's ampullary carcinoma or biliary adenocarcinoma；
  • Patients with partial or complete intestinal obstruction and complete biliary obstruction that cannot be relieved by active treatment;
  • With more than a moderate amount of ascites, or after conservative medical treatment (such as diuresis, sodium restriction, excluding ascites drainage) for 2 weeks, the ascites still shows a progressive increase；
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  • A history of other malignant tumors in the past 5 years, except for the following two cases: a. Other malignant tumors treated by a single operation, achieving 5 consecutive years of disease-free survival; b. Cured skin basal cell carcinoma and cured cervical carcinoma in situ;
  • Pregnant or lactating female;
  • Suffer from severe chronic or active infections, including tuberculosis, syphilis, AIDS (HIV antibody positive)；
  • Hypertension that cannot be effectively controlled (defined as systolic/diastolic blood pressure ≥150/100 mmHg or meeting one of them after treatment with standardized antihypertensive drugs); Angina pectoris or unstable angina pectoris occurred within the last 3 months, myocardial infarction or cardiac insufficiency occurred within 1 year before enrollment (heart function ≥ New York Heart Association NYHA grade II); Severe arrhythmia requiring medical treatment, left ventricular ejection fraction <50%; QTc interval male>450ms, female>470ms; Or there are risk factors for torsade de pointes ventricular tachycardia, such as clinically significant hypokalemia as judged by the investigator; Family history of long QT syndrome or family history of arrhythmia (such as WPW syndrome); Schizophrenia, or history of psychotropic drug abuse;
  • Suffer from acute or chronic active hepatitis (Hepatitis B reference: HbsAg positive and HBV DNA viral load ≥200IU/mL or ≥10^3 copies/mL, HCV antibody positive and HCV RNA positive);
  • Received any of the following treatments within a certain period of time before enrollment: a.Received second-level or above surgery within 4 weeks (regardless of tumor-related or not), except for minimally invasive surgery under gastrointestinal endoscope; b. Received extended-range radiotherapy within 4 weeks, or received local-range radiotherapy within 2 weeks; c. Other clinical studies have been taken in the past 4 weeks; d. Received local anti-tumor therapy within 4 weeks；
  • Toxicity caused by previous anti-tumor therapy before the first dose has not yet recovered to NCI CTCAE version 5.0 grade 0 or 1 (excluding hair loss, skin pigmentation, and non-clinically significant and asymptomatic laboratory abnormalities)；
  • Known to be allergic or intolerant to OH2 and its excipients；
  • The researchers believe that there is any reason why the patient is not suitable to participate in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

Other trials in China

About this study

Official title: Phase Ib/II Study of OH2 Injection, an Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor, in Pancreatic Cancer

This phase Ib/II study evaluates the safety and efficacy of OH2 in patients with locally advanced/metastatic pancreatic cancer who have failed first-line standard treatment.

OH2 is an oncolytic virus developed upon genetic modifications of the herpes simplex virus type 2 strain HG52, allowing the virus to selectively replicate in tumors. Meanwhile, the delivery of the gene encoding human granulocyte macrophage colony-stimulating factor (GM-CSF) may induce a more potent antitumor immune response.

Read the detailed description

OH2 injection ≤ 4 mL, administered by intratumoral injection of EUS-FNA, administered on the first day of the first cycle, every 3 weeks thereafter, administered on the 1st day of each cycle ± 3 days, continuous administration does not more than 6 treatment cycles.

Being tested
OH2 injection
Keywords
Oncolytic Virus
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • OH2 injectionBiological

    Oncolytic Type 2 Herpes Simplex Virus

Study groups in NCT04637698
Study groupRoleWhat they receive
Dose expansionExperimentalOH2 injection will be administered at 1E+07 CCID50/mL .
Receives: Biological: OH2 injection

What is being measured

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

  1. The objective response rate of patients with pancreatic cancer receiving OH2 injection.

    Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. The assessment result is the number and proportion of subjects with complete response + partial response.

    Measured: 2 years

Secondary outcomes (5)

  1. Evaluation of safety of OH2 injection in patients with pancreatic cancer.

    According to the version 5.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events, the adverse events during the entire study period are evaluated.

    Measured: 2 years

  2. The disease control rate of patients with pancreatic cancer receiving OH2 injection.

    Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. The assessment result is the number and proportion of subjects with complete response + partial response + stable disease.

    Measured: 2 years

  3. The duration of response of patients with pancreatic cancer receiving OH2 injection

    Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. The time from the first assessment of complete response or partial response to the first assessment of disease progression or death from any cause.

    Measured: 2 years

  4. The progression free survival of patients with pancreatic cancer receiving OH2 injection.

    Tumor evaluation is performed according to RECIST1.1 and iRECIST1.1. Time from start of treatment to disease progression.

    Measured: 2 years

  5. To evaluate the impact of OH2 in patients with pancreatic cancer on the quality of life

    Evaluation based on EORTC QLQ-C30.

    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 posted20 Nov 2020
  2. Study start2 Feb 2021
  3. Primary completion4 May 2023
  4. Study completion4 May 2023

Why it stopped: Strategy adjustment

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04637698
Sponsor's protocol ID
BH-OH2-006
Status last verified
Nov 2023
First submitted
16 Nov 2020
Last updated
24 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OH2 injection in people with Pancreatic 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 11 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Nov 2023. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study was stopped early (reason given: Strategy adjustment). Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The objective response rate of patients with pancreatic cancer receiving OH2 injection. (time frame: 2 years). 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 NCT04637698.

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 24 Nov 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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