NeoplasmsPhase 1NCT04787003
Oncolytic Virus (OVV-01) Injection in the Treatment of Patients With Advanced Solid Tumors
A Phase 1 study testing oncolytic virus (OVV-01) injection in people with Neoplasms, run by North China Petroleum Bureau General Hospital at 1 site in China.
Trial summary
Phase Ia: To investigate the safety, tolerability and efficacy of OVV-01 injection in the treatment of patients with advanced solid tumors (OVV-01 single dose gradient exploration). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Neoplasms
- What is being tested?
- oncolytic virus (OVV-01) injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 16 Feb 2021to 28 Feb 2024
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 18 and ≤ 70 years;
- Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary tumor and/or metastases, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer;
- Patients for the third-line or higher standard therapy failed;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- ECOG score of 0 ~ 2;
- Expected survival ≥ 3 months;
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- Adequate bone marrow function;
- WBC ≥ 3.0 × 109/L;
- Neutrophils (ANC) ≥ 1.5 × 109/L;
- Lymphocyte count ≥ 6.0 × 108/L
- Platelets ≥ 90 × 109/L without transfusion within 14 days prior to starting the first cell therapy;
- Hemoglobin ≥ 10.0 g/dL
- Adequate hepatic and renal function:
- Total bilirubin ≤ 1.5 × ULN.
- AST and ALT < 2.5 × ULN; < 5 × ULN AST for patients with liver metastases;
- Blood creatinine ≤ 1.5 × ULN, or creatinine clearance rate ≥ 50 ml/min (calculation with Cockcroft/Gault formula)
- Coagulation function:
- INR ≤ 1.5 × ULN
- PTT ≤ 1.5 × ULN
- Adequate cardiovascular function:
- Epilepsy score (EF) ≥ 50%
- QTcF interval ≤ 450 ms
- Women of childbearing age who have a negative pregnancy test within 14 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method (such as surgical sterilization, oral contraceptives, intrauterine device, sexual abstinence or barrier contraception combined with spermicide, etc.) during study treatment and within at least 6 months after the last dose of investigational drug;
- The patients voluntarily participated in this study, signed the informed consent form, had good compliance, and cooperated with the follow-up.
Who cannot join
- Subjects without measurable lesions;
- Subjects with known brain metastasis and/or clinically suspected tumor brain metastasis (patients with asymptomatic brain metastasis or clinically stable for more than 3 months after local treatment can be excluded);
- Subjects who have received radiotherapy for target lesion within 2 months;
- Subjects with other active malignancies requiring concurrent treatment;
- Subjects with known hypersensitivity to the investigational drug or its active ingredients and excipients;
- Subjects who have received or are still receiving treatment with other investigational drugs or antiviral therapy 4 weeks before randomization;
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- Subjects preparing for or having received tissue/organ transplantation preciously;
- Subjects having any active infection or unexplained fever > 38.5℃ during the screening period, prior to the first dose;
- Subjects with active pulmonary tuberculosis (TB) who are receiving anti-TB treatment or who have received anti-TB treatment within 1 year before screening;
- Subjects with positive result of serological test for Treponema pallidum;
- Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
- Subjects with active hepatitis. Hepatitis B: hepatitis B virus surface antigen (HBVs Ag) positive or HBVsAg negative, but anti-HBVc positive and HBV DNA test value higher than the upper limit of normal; hepatitis C: hepatitis C virus antibody (HCV Ab) positive and HCV RNA positive; with hepatitis B and C co-infection;
- Cardiovascular system disorders meeting any of the following:
- Congestive heart failure with cardiac function ≥ NYHA III;
- Serious arrhythmia requiring medication;
- Acute myocardial infarction, severe or unstable angina pectoris, coronary artery or peripheral artery bypass grafting or stenting within 6 months prior to the first dose;
- Left ventricular ejection fraction (LVEF) < 50%;
- Corrected QTc interval > 450 ms for males and > 470 ms for females, or presence of risk factors for torsades de pointes such as clinically significant hypokalemia, family history of long QT syndrome or family history of arrhythmia (e.g., Wolff-Parkinson-White syndrome) as judged by the investigator;
- Hypertension not effectively controlled (defined as systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg after standardized antihypertensive drug therapy)
- Patients with active autoimmune diseases or history of autoimmune diseases that may relapse, but patients with the following diseases are not excluded, may be further screened:
- Type 1 diabetes;
- Hypothyroidism (if controlled with hormone replacement therapy alone);
- Controlled celiac disease;
- Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia);
- Any other disease that will not recur in the absence of external triggers;
- Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days prior to investigational drug administration, but currently or previously treated with any of the following steroid regimens, were included:
- Adrenaline replacement steroid (prednisone ≤ 10 mg/day or equivalent of the similar drug);
- Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption;
- Prophylactic short-term (≤ 7 days) use of corticosteroids (e.g., allergy to contrast media) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens);
- Subjects having mental illness, alcoholism, inability to quit smoking or drug abuse;
- Female subjects who are pregnant or lactating, or expecting to become pregnant during the trial (from the screening visit until 180 days after dosing) and male subjects who are expecting to father children;
- Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia);
- Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator.
- Subjects in other conditions that are considered unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
North China Petroleum Bureau General Hospital
Cangzhou, Hebei, 062552
QIANG LIN, Dr, +86-317-272-1951, billhappy001@163.com
About this study
Official title: A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Oncolytic Virus (OVV-01) Injection Combined With or Without Immune Checkpoint Inhibitors in the Treatment of Patients With Advanced Solid Tumors
Phase Ia: To investigate the safety, tolerability and efficacy of OVV-01 injection in the treatment of patients with advanced solid tumors (OVV-01 single dose gradient exploration).
Phase Ib: To evaluate the safety, tolerability and efficacy of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in the treatment of patients with advanced solid tumors (OVV-01 combined with PD-1/PD-L1 monoclonal antibody dose gradient exploration);
Phase Ic: A cohort expansion of Phase Ib to further analyze the efficacy and safety of OVV-01 injection combined with immune checkpoint inhibitor injection in the treatment of advanced solid tumors.
Read the detailed description
Phase Ia:
This is a prospective, multicenter, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection in patients with advanced solid tumors.
This study plans to enroll in 1 ~ 3 study sites nationwide about 9 ~ 18 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ia study, i.e., the First in Human (FIH) trial of OVV-01 injection, using the traditional "3 + 3" approach for dose gradient exploration.
Phase Ib:
This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.
This study plans to enroll in 1 ~ 3 study sites nationwide about 12 ~ 24 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ib study, using the traditional "3 + 3" approach and based on the phase Ia results, 2 dose gradients of OVV-01 are used in combination with pembrolizumab and atezolizumab, respectively, to explore the efficacy and safety.
Phase Ic:
This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.
This study plans to enroll in 1 ~ 3 study sites nationwide about 15 ~ 20 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ic study.
- Conditions
- Neoplasms
- Being tested
- oncolytic virus (OVV-01) injection
- Keywords
- Oncolytic Virus Injection, Intratumoral Injection, Immune Checkpoint Inhibitors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oncolytic virus (OVV-01) injectionDrug
Also called C045
intratumoral injection of OVV-01 with or without immune checkpoint inhibitors
| Study group | Role | What they receive |
|---|---|---|
| Oncolytic virus (OVV-01) injection for patients with advanced solid tumors | Experimental | Oncolytic virus (OVV-01) injection combined with or without immune checkpoint inhibitors in the treatment of patients with advanced solid tumors. Receives: Drug: oncolytic virus (OVV-01) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
to define the MTD of OVV-01
to define the maximum tolerated dose (MTD) of intratumoral administration of OVV-01 injection in humans with malignant tumors.
Measured: 6 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
to evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in patients with advanced solid tumors.
Measured: 8 months
Secondary outcomes (2)
To evaluate the efficacy assessed by the RECISTv1.1 of OVV-01
to evaluate preliminary efficacy assessed by the RECISTv1.1 of intratumoral administration of OVV-01 injection in the treatment of patients with advanced solid tumors
Measured: 6 months
To evaluate the efficacy assessed by the RECISTv1.1 of OVV-01 with ICIs
to evaluate the preliminary efficacy assessed by the RECISTv1.1 of intratumoral administration of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in patients with advanced solid tumors
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start16 Feb 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- North China Petroleum Bureau General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Joint Biosciences Ltd.
- Responsible party
- Sponsor
- Investigators
- Qiang Lin, Ph.D, Principal investigator, North China Petroleum Bureau General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787003
- Sponsor's protocol ID
- RR-001
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the publication of this study, we could share the IPD. However, this sharing is limited to academic research. Person to be contacted: Study Chair-Professor Qiang Lin; Contact information:billhappy001@163.com
Publications
Hua Y, Wang C, Li F, Han Y, Zuo D, Lv Y, Sun M, Yuan P, Yuan R, Zhang F, Ma L, Wang Y, Wu H, Zhou G, Lin Q, Wang S, Li N, Lu Y; North China Petroleum Bureau General Hospital. Phase 1, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors. J Immunother Cancer. 2025 Jun 5;13(6):e011517. doi: 10.1136/jitc-2025-011517.
PubMed 40480657
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Oncolytic Virus (OVV-01) Injection Combined With or Without Immune Checkpoint Inhibitors in the Treatment of Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04787003
- Acronym / sponsor ID
- RR-001
- Conditions
- Neoplasms
- Keywords
- Oncolytic Virus Injection, Intratumoral Injection, Immune Checkpoint Inhibitors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- North China Petroleum Bureau General HospitalUniversity, hospital or other
- Collaborators
- Joint Biosciences Ltd.
- Study start
- 16 Feb 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 8 Mar 2021 (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.
Phase Ia: To investigate the safety, tolerability and efficacy of OVV-01 injection in the treatment of patients with advanced solid tumors (OVV-01 single dose gradient exploration).
Phase Ib: To evaluate the safety, tolerability and efficacy of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in the treatment of patients with advanced solid tumors (OVV-01 combined with PD-1/PD-L1 monoclonal antibody dose gradient exploration);
Phase Ic: A cohort expansion of Phase Ib to further analyze the efficacy and safety of OVV-01 injection combined with immune checkpoint inhibitor injection in the treatment of advanced solid tumors.
Detailed description
Phase Ia:
This is a prospective, multicenter, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection in patients with advanced solid tumors.
This study plans to enroll in 1 ~ 3 study sites nationwide about 9 ~ 18 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ia study, i.e., the First in Human (FIH) trial of OVV-01 injection, using the traditional "3 + 3" approach for dose gradient exploration.
Phase Ib:
This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.
This study plans to enroll in 1 ~ 3 study sites nationwide about 12 ~ 24 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ib study, using the traditional "3 + 3" approach and based on the phase Ia results, 2 dose gradients of OVV-01 are used in combination with pembrolizumab and atezolizumab, respectively, to explore the efficacy and safety.
Phase Ic:
This is a prospective, multi-center, open-label, single-arm investigator-initiated clinical study to evaluate the safety and efficacy of intratumoral injection of OVV-01 injection combined with immune checkpoint inhibitors in patients with advanced solid tumors.
This study plans to enroll in 1 ~ 3 study sites nationwide about 15 ~ 20 patients with advanced solid tumors for whom the standard treatment failed and currently no standard treatment is available or standard treatment is not suitable due to medical reasons, to conduct a phase Ic study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncolytic virus (OVV-01) injection for patients with advanced solid tumors | Experimental | Drug: oncolytic virus (OVV-01) injectionOncolytic virus (OVV-01) injection combined with or without immune checkpoint inhibitors in the treatment of patients with advanced solid tumors. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Male or female aged ≥ 18 and ≤ 70 years;
- Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary tumor and/or metastases, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, liver cancer, gastric cancer;
- Patients for the third-line or higher standard therapy failed;
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- ECOG score of 0 ~ 2;
Key exclusion criteria (34 listed)
- Subjects without measurable lesions;
- Subjects with known brain metastasis and/or clinically suspected tumor brain metastasis (patients with asymptomatic brain metastasis or clinically stable for more than 3 months after local treatment can be excluded);
- Subjects who have received radiotherapy for target lesion within 2 months;
- Subjects with other active malignancies requiring concurrent treatment;
- Subjects with known hypersensitivity to the investigational drug or its active ingredients and excipients;
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 |
|---|---|---|
| oncolytic virus (OVV-01) injectionAlso: C045intratumoral injection of OVV-01 with or without immune checkpoint inhibitors | Drug | Oncolytic virus (OVV-01) injection for patients with advanced solid tumors |
Primary outcome
to define the MTD of OVV-01
Time frame: 6 months
to define the maximum tolerated dose (MTD) of intratumoral administration of OVV-01 injection in humans with malignant tumors.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 8 months
to evaluate the number of Grade III and above side effects assessed by CTCAE v5.0 for patients who received intratumoral administration of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in patients with advanced solid tumors.
2 secondary outcomes
To evaluate the efficacy assessed by the RECISTv1.1 of OVV-01
Time frame: 6 months
To evaluate the efficacy assessed by the RECISTv1.1 of OVV-01 with ICIs
Time frame: 8 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Derived from this study: PubMed 40480657Hua Y, Wang C, Li F, Han Y, Zuo D, Lv Y, Sun M, Yuan P, Yuan R, Zhang F, Ma L, Wang Y, Wu H, Zhou G, Lin Q, Wang S, Li N, Lu Y; North China Petroleum Bureau General Hospital. Phase 1, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors. J Immunother Cancer. 2025 Jun 5;13(6):e011517. doi: 10.1136/jitc-2025-011517.
- Individual participant dataSharing planned: Yes. After the publication of this study, we could share the IPD. However, this sharing is limited to academic research. Person to be contacted: Study Chair-Professor Qiang Lin; Contact information:billhappy001@163.com
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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. This study is not recruiting at the moment.
Qiang Lin, Ph.D principal investigator
North China Petroleum Bureau General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oncolytic virus (OVV-01) injection in people with Neoplasms, run by North China Petroleum Bureau General Hospital 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 24 inclusion and 34 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: status not confirmed, as of the sponsor's last update on 23 Mar 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan-hua Bi, M.D (+86-317-272-8295, zyy_byh@petrochina.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to define the MTD of OVV-01 (time frame: 6 months). 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 NCT04787003, which also lists 1 linked publication.
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 23 Mar 2023.