Solid TumorPhase 1NCT05954091
OH2 Administered by Intratumoral Injection
A Phase 1 study testing OH2 Injection in people with Solid Tumor, run by Binhui Biopharmaceutical Co., Ltd..
Trial summary
This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of OH2 in patients with locally advanced/metastatic solid… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- 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
- 29 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jan 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥ 18 years old
- Subject must have histologically- or cytologically-confirmed diagnosis of unresectable locally advanced or metastatic melanoma, pancreatic cancer, liver metastases from colorectal cancer, breast cancer, and other solid tumors. (Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer etc. Part 2 Cohort B will include patients who have visceral tumors.)
- Subject has measurable disease as determined by RECIST version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
- Subjects who have progressed on or are ineligible for available standard therapy are eligible for this trial after the last dose of the previous treatment which is ≥ 4 weeks or 5 half-lives (if required) before the first dose of study treatment. Note: patients who have previously been treated with IMLYGIC (Talimogene laherparepvec, T-Vec) are eligible after discontinuing the last dose of previous T-Vec treatment for ≥ 12 weeks before first dose of study treatment.
- Subject has a predicted life expectancy ≥ 12 weeks.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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- A female subject is eligible to participate if she is not pregnant and at least 1 of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- WOCBP who agrees to use an acceptable form of birth control method, including:
- abstinence, hormonal contraception for at least 3 months in combination with a barrier method, intrauterine device (placement at least 3 months prior to screening), cervical cap, condoms with contraceptive gel/foam/cream, or surgical sterilization (tubal ligation at least 6 months prior to screening or partner who had a vasectomy at least 6 months prior to screening).
- Female subject must agree not to breastfeed starting at screening, throughout the study period and 180 days after the final study IP administration.
- Female subject must not donate ova starting at screening, throughout the study period and for 180 days after the final study IP administration.
- Male subject must agree to remain abstinent or use a condom throughout the study period and for 180 days after the final study IP administration.
- Male subject with female partner(s) of childbearing potential must agree to use contraception during the treatment period and for at least 180 days after the final study IP administration.
- Male subject must not donate sperm during the treatment period and for at least 180 days after the final study IP administration.
- Subject must be willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
- Subject agrees not to participate in another interventional study while receiving study IP.
- Subject has the ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Subject has ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant determined by the Investigator.
- Subject has had major surgery ≤ 4 weeks of screening.
- Subject is concurrently participating in another interventional study or has received an investigational product < 4 weeks or 5 half-lives (if required) prior to first IP administration.
- Subject with symptomatic central nervous system (CNS) metastases, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT/MRI for ≥ 3 months and have been off steroids for at least 4 weeks prior to first IP administration.
- Subject with active autoimmune disease requiring systemic therapy within past 2 years. (e.g., systemic lupus erythematosus, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, hypophysitis, etc.). The following are exceptions to this criterion:
- Subject with vitiligo or alopecia
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- Subject with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
- Childhood asthma that has resolved
- Any chronic skin condition that does not require systemic therapy
- Type 1 diabetes mellitus ※Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
- Subject with another malignancy that currently requires treatment.
- Subject with tumors encasing major vascular structures such as the carotid artery, tumors adjacent to vital neurovascular structures or tumors in locations that are at high risk for AEs or otherwise not considered appropriate for IT injection.
- Subject with inadequate organ and marrow functions meeting any of the below criteria:
- with ongoing continuous supportive treatment
- Leukocytes < 3000/μL
- Absolute neutrophil count < 1500/μL
- Platelets < 100,000/μL
- Hemoglobin (Hgb) < 9 g/dL
- International normalized ratio (INR) > 1.5 × ULN and/or activated partial thromboplastin time (aPTT) > 1.5 × institutional normal limits, except for patients in Group B (Visceral Lesions) escalation and expansion groups where INR and aPTT must be normal
- Total Bilirubin (TBL) > 1.5 × institutional normal limits (subjects with known Gilbert syndrome who are excluded if TBL > 3.0 × institutional normal limits or direct bilirubin > 1.5 × institutional normal limits)
- Aspartate aminotransferase (AST) and Alanine transaminase (ALT) > 3.0 × institutional normal limits. Subjects with tumors in the liver AST and ALT > 5 × institutional normal limits.
- Albumin < 3.0 g/dL
- Creatinine > 1.5 × institutional normal limits
- Subject with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of first administration of study IP. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- Subject has an uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, any form of substance abuse or psychiatric illness/social situations that would limit compliance with study visits or requirements, or a condition that could invalidate communication with the Investigator.
- Subject is known to be positive for human immunodeficiency virus, hepatitis B surface antigen, hepatitis B core immunoglobulin or immunoglobulin G (IgG) antibody, or hepatitis C (IgG or ribonucleic acid (RNA) test) indicating acute or chronic infection. HbsAg positive subject should further undergo hepatitis B virus (HBV) DNA titer detection. For HCV antibody positive subject, further HCV RNA testing is required. However, subject with the following conditions can be included in this study: Hepatitis B surface antigen (HBsAg) is negative; if HBcAb is positive, HBV-DNA (HBV deoxyribonucleic acid) < 200 IU/mL (or 1000 copies/mL).
- Subject has a history of moderate to severe ascites, clinically significant and/or rapidly accumulating ascites, bleeding esophageal varices, hepatic encephalopathy, or pericardial and/or pleural effusions related to liver insufficiency within 6 months of screening. Mild ascites that does not preclude safe IT injection of OH2 is allowed.
- Subject has a clinically significant abnormal electrocardiogram (ECG) at screening.
- Subject has symptomatic cardiovascular disease within the preceding 12 months unless cardiology consultation and clearance has been obtained for study participation, including but not limited to the following: significant coronary artery disease (e.g., requiring angioplasty or stenting), acute myocardial infarction or unstable angina pectoris < 3 months prior to screening, uncontrolled hypertension, clinically significant arrhythmia, or congestive heart failure (New York Heart Association grade ≥ 2).
- Subject who has a history of bleeding diathesis, are on anti-coagulation therapy, or have abnormal coagulation-fibrinolytic parameters (e.g., activated partial thromboplastin time (APTT), prothrombin time (PT), thrombin time (TT), and platelet count).
- Subject has medical conditions that predispose the subject to untoward medical risk in the event of volume loading (e.g., intravenous fluid bolus infusion), tachycardia, or hypotension during or following treatment with OH2.
- Subject has a known or suspected hypersensitivity to OH2 or any components of the formulation used, including prior adverse reaction to vaccinia (e.g., as smallpox vaccine).
- Subject has had previous exposure with OH2.
- Active herpetic skin lesions or prior complications of herpetic infection (e.g., herpetic keratitis or encephalitis).
- Requires intermittent or chronic systemic (intravenous or oral) treatment with an antiherpetic drug (e.g., acyclovir), other than intermittent topical use.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 1, Open-label Study of OH2, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors
This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of OH2 in patients with locally advanced/metastatic solid tumors.
Read the detailed description
Eligible patients are those who have measurable solid tumors as detected by CT or MRI that have persisted, recurred, or metastasized despite therapy. Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer, etc. Part 2 Cohort B will include patients who have visceral tumors. Patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) but did not achieve an optimal response to T-Vec are eligible to receive OH2 if otherwise per protocol (refer to Section 5 for detailed enrollment criteria). The study will be conducted in 2 parts as described below. Both parts will consist of a screening period of up to 28 days, a treatment period and a follow-up period (safety and long-term follow up). Treatment period of Part 1 will include an initial treatment period (namely DLT (dose-limiting toxicity) observation period, 3 doses of OH2) and an optional extended treatment period (repeated every 2 weeks).
- Conditions
- Solid Tumor
- Being tested
- OH2 Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OH2 InjectionDrug
Also called BS001
OH2 injection will be given intratumorally, and Q2W.
| Study group | Role | What they receive |
|---|---|---|
| OH2 Injection | Experimental | Subjects will get OH2 injection every two weeks, and up to 8mL for each treatment. There will have three virus titers: 1×10^6 CCID50/mL, 5×10^6 CCID50/mL, 1×10^7 CCID50/mL. Receives: Drug: OH2 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)
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: Through study completion, an average of about 1 year(a maximum treatment duration of one year)
Maximum tolerated dose (MTD)
To estimate the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of OH2
Measured: up to 1 year
Secondary outcomes (5)
Overall response rate (ORR)
Determination of the ORR is calculated based on the proportion of patients achieving complete response (CR) or partial response (PR) using the RECIST v1.1 and modified WHO response criteria as assessed.
Measured: up to 1 year
Disease control rate (DCR)
DCR is defined as the percentage of participants with a best overall response of CR, PR, or stable disease (SD).
Measured: up to 1 year
Biological activity
Granulocyte macrophage colony stimulating factor (GM-CSF) mRNA expression in fine needle aspirate (FNA)(Only for Part 1)
Measured: up to 1 year
Biodistribution
OH2 DNA copy in blood and urine
Measured: 3 months
Viral shedding
OH2 DNA copy in swab of surface of injected lesion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Sep 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binhui Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954091
- Sponsor's protocol ID
- BH-OH2-007
- Status last verified
- Dec 2024
- First submitted
- 5 Jun 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study of OH2, an Oncolytic Virus, Administered by Intratumoral Injection in Patients with Advanced/Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05954091
- Acronym / sponsor ID
- BH-OH2-007
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Binhui Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be a Phase 1, multi-center, open-label, dose escalation followed by the recommended phase 2 dose (RP2D) expansion study to characterize safety, tolerability, biodistribution, virus shedding and preliminary efficacy of intratumoral injection of OH2 in patients with locally advanced/metastatic solid tumors.
Detailed description
Eligible patients are those who have measurable solid tumors as detected by CT or MRI that have persisted, recurred, or metastasized despite therapy. Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer, etc. Part 2 Cohort B will include patients who have visceral tumors. Patients who were previously treated with IMLYGIC (Talimogene laherparepvec, T-Vec) but did not achieve an optimal response to T-Vec are eligible to receive OH2 if otherwise per protocol (refer to Section 5 for detailed enrollment criteria). The study will be conducted in 2 parts as described below. Both parts will consist of a screening period of up to 28 days, a treatment period and a follow-up period (safety and long-term follow up). Treatment period of Part 1 will include an initial treatment period (namely DLT (dose-limiting toxicity) observation period, 3 doses of OH2) and an optional extended treatment period (repeated every 2 weeks).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OH2 Injection | Experimental | Drug: OH2 InjectionSubjects will get OH2 injection every two weeks, and up to 8mL for each treatment. There will have three virus titers: 1×10^6 CCID50/mL, 5×10^6 CCID50/mL, 1×10^7 CCID50/mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Male or female subjects aged ≥ 18 years old
- Subject must have histologically- or cytologically-confirmed diagnosis of unresectable locally advanced or metastatic melanoma, pancreatic cancer, liver metastases from colorectal cancer, breast cancer, and other solid tumors. (Part 1 and Part 2 Cohort A will include patients who have solid tumors with cutaneous/subcutaneous tumor lesions, such as melanoma, cutaneous squamous cell carcinoma, and cutaneous/subcutaneous metastasis from pancreatic cancer, colorectal cancer, breast cancer etc. Part 2 Cohort B will include patients who have visceral tumors.)
- Subject has measurable disease as determined by RECIST version 1.1. At least 1 lesion must be suitable for intratumoral (IT) injection. Lesions for injection must be ≥ 10 mm and ≤ 60 mm in longest diameter.
- Subjects who have progressed on or are ineligible for available standard therapy are eligible for this trial after the last dose of the previous treatment which is ≥ 4 weeks or 5 half-lives (if required) before the first dose of study treatment. Note: patients who have previously been treated with IMLYGIC (Talimogene laherparepvec, T-Vec) are eligible after discontinuing the last dose of previous T-Vec treatment for ≥ 12 weeks before first dose of study treatment.
- Subject has a predicted life expectancy ≥ 12 weeks.
Key exclusion criteria (35 listed)
- Subject has ongoing toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2 attributable to prior antineoplastic therapies considered clinically significant determined by the Investigator.
- Subject has had major surgery ≤ 4 weeks of screening.
- Subject is concurrently participating in another interventional study or has received an investigational product < 4 weeks or 5 half-lives (if required) prior to first IP administration.
- Subject with symptomatic central nervous system (CNS) metastases, except patients with CNS lesions that have been treated and have no evidence of progression in the brain on CT/MRI for ≥ 3 months and have been off steroids for at least 4 weeks prior to first IP administration.
- Subject with active autoimmune disease requiring systemic therapy within past 2 years. (e.g., systemic lupus erythematosus, Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, hypophysitis, etc.). The following are exceptions to this criterion:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OH2 InjectionAlso: BS001OH2 injection will be given intratumorally, and Q2W. | Drug | OH2 Injection |
Primary outcome
Incidence of Adverse Event (AE) and Serious Adverse Event (SAE)
Time frame: Through study completion, an average of about 1 year(a maximum treatment duration of one year)
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
Maximum tolerated dose (MTD)
Time frame: up to 1 year
To estimate the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of OH2
5 secondary outcomes
Overall response rate (ORR)
Time frame: up to 1 year
Disease control rate (DCR)
Time frame: up to 1 year
Biological activity
Time frame: up to 1 year
Biodistribution
Time frame: 3 months
Viral shedding
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OH2 Injection in people with Solid Tumor, run by Binhui Biopharmaceutical Co., Ltd..
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 18 inclusion and 35 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: opening soon, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Yue Su (+86 17307121014, suyue@binhui-bio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Event (AE) and Serious Adverse Event (SAE) (time frame: Through study completion, an average of about 1 year(a maximum treatment duration of one year)). 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?
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 27 Dec 2024.