Advanced Solid TumorsPhase 1NCT07648472
A Study of the Safety and Efficacy of the Intravenous and Intratumoral Injection of OVV-01 in Patients With Advanced Solid Tumours.
A Phase 1 study testing OVV-01 Injection in people with Advanced Solid Tumors, run by Joint Biosciences Ltd. at 1 site in China.
Trial summary
This is an open-label, single-arm, dose escalation clinical study to evaluate the safety and preliminary efficacy of OVV-01 Injection in patients with advanced solid tumors, following both intravenous (iv.) and intratumoral (it.) injections. This study consists of two parts: Part 1 is a dose escalation study of iv. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- OVV-01 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2026to 20 Apr 2027
- 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
- Be willing to sign the ICF, be able to understand the study, and be willing to follow the protocol and complete all the study procedures;
- Males or females aged ≥18 years when signing the ICF;
- Patients with advanced solid tumors (including but not limited to melanoma, squamous cell carcinoma of head and neck, cervix carcinoma, bone sarcoma, nasopharyngeal cancer, breast cancer, lung cancer, colorectal cancer, hepatic cancer, and gastric cancer) as histopathologically or cytologically confirmed by primary lesions and/or metastases; Patients with unresectable locally advanced disease will be included, while patients with resectable disease will be excluded.
- Patients who experienced treatment failure to standard of care, have no available standard of care, or are not suitable for standard of care due to medical reasons. Patients need to have progressed on at least two lines of standard of care therapy including but not limited to targeted therapy. For example, patients with metastatic or unresectable advanced melanoma who experienced treatment failure to standard of care such as anti-PD-1 antibody (patients harboring BRAF mutations who experienced treatment failure to BRAF and MEK inhibitors); patients with recurrent or metastatic advanced squamous cell carcinoma of head and neck who may have experienced standard treatment failure approved to anti-PD-1 monoclonal antibody and platinum-based chemotherapy; patients with recurrent or metastatic osteosarcoma who experienced treatment failure to chemotherapy drugs (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.); patients with colorectal cancer who have received standard of care fluoropyrimidine, oxaliplatin, Bevacizumab, and irinotecan-based chemotherapy, patients with wild-type KRAS who have received anti-EGFR, and patients with microsatellite instability-high disease who have received at least one prior immune checkpoint inhibitor; patients with breast cancer (including HR positive, HER2 +, and triple negative breast cancer) who have received at least 2 prior lines which should include taxane and/or anthracycline-based therapy where appropriate and an approved checkpoint inhibitor;
- Patients with at least one measurable lesion per RECIST v1.1, i.e., the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to computed tomography (CT) or magnetic resonance imaging (MRI); The patient should also have injected tumor lesions for Part 2, including cutaneous or subcutaneous visible nodal lesions or lesions palpable deemed injectable, and hepatic lesions or non-subcutaneous lymph nodes such as retroperitoneal. These lesions should be deemed feasible for injection either directly (palpable subcutaneous tumors) by a qualified investigator or under CT or ultrasound guidance (based on size, location, and visibility); All injected tumors should be > 1 cm in size;
- Patients with an ECOG score of 0-1 and an expected survival of at least 12 weeks;
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- Patients with adequate organ and hematopoietic function:
- ANC ≥1.5×10 9/L; Platelet count ≥75×10 9/L (no platelet transfusion or thrombopoietin [TPO] within 2 weeks prior to the first dose); Haemoglobin ≥90 g/L (no blood transfusion within 2 weeks); Serum creatinine ≤1.5×ULN or endogenous creatinine clearance (CCr) ≥50 mL/min; AST and ALT ≤3.0×ULN; AST and ALT ≤5×ULN for patients with liver metastases; Serum TBIL ≤2×ULN; International normalized ratio (INR) ≤1.5×ULN or activated partial thromboplastin time (APTT) ≤1.5×ULN;
- Female patients of childbearing potential must have a negative pregnancy test result within 7 days prior to the study treatment;
- Male patients of reproductive potential and female patients of childbearing potential must agree to use a reliable contraceptive method during the study and at least 6 months after the last dose.
Who cannot join
- Patients with known brain metastases and/or clinically suspected brain metastases (however, patients with asymptomatic brain metastases or who have been clinically stable for more than 3 months after local treatment can be enrolled);
- Patients who received radiotherapy for the target lesion in the past 2 months;
- Patients with other active malignancies in the past 5 years shall be excluded, with the exceptions for those who are completely cured and do not require follow-up treatment, and those with study indications;
- The longest diameter of the injected lesion is >100 mm for Part 2;
- Patients participated (in the past 4 weeks) or are participating in clinical studies of the other drugs or medical devices;
- Patients who plan to receive or received tissue or organ transplant;
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- Patients with human immunodeficiency virus (HIV) infection and acquired immune deficiency (AID)-related opportunistic infection within 12 months, or CD4+ T-cell (CD4+) count <350 cells/uL; patients with positive results for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), and a hepatitis B virus deoxyribonucleic acid (HBV-DNA) level higher than the lower limit of detection at screening; patients with positive result for hepatitis C virus (HCV) antibody and a hepatitis C virus ribonucleic acid (HCV-RNA) level higher than the lower limit of detection at screening; patients with positive serology result for treponema pallidum;
- Patients requiring antivirals during the study or those who are within 5 half-lives of antivirals at the time of the first dose of the study drug;
- Patients requiring therapeutic anticoagulation during the study;
- Patients with uncontrolled Grade ≥3 active infection and significant clinical relevance per CTCAE v5.0;
- Patients who received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor drugs within 4 weeks prior to the first dose; small molecule targeted therapy and oral dose of fluorouracils within 2 weeks or 5 half-lives (whichever longer) prior to the first dose; Chinese herbal medicines or Chinese patent medicines with anti-tumor indications within 2 weeks prior to the first dose; nitrosourea or mitomycin C within 6 weeks prior to the first dose; however, patients who received palliative radiotherapy for non-target lesions are allowed (≥2 weeks prior to the first dose);
- Uncontrolled hypertension, pulmonary arterial hypertension or angina unstable; myocardial infarction, bypass or stent surgery within 6 months prior to the first dose; history of Grade 3-4 chronic heart failure according to New York Heart Association (NYHA) criteria; serious arrhythmia requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia that have no effect on the study as assessed by the investigator), including QTcF ≥450 ms for males and ≥470 ms for females (calculated by Fridericia's formula); cerebrovascular accident (CVA) or transient ischaemic attack (TIA) within 6 months prior to enrollment;
- Patients with active autoimmune disease or history of autoimmune disease that may relapse, however, patients with the following diseases are not excluded and may be further screened:
- Type 1 diabetes mellitus; Thyroid function decreased (if controlled with hormone replacement therapy only); Controlled coeliac disease; Skin diseases that do not require systemic treatment (e.g., vitiligo, psoriasis, alopecia); Any other disease that does not recur without an external triggering factor;
- Patients who require systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive medication within 14 days prior to the first dose or during the study, with the following exceptions:
- Adrenaline replacement steroids (prednisone ≤10 mg/day or equivalent); Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids; 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 reactions caused by contact allergens);
- Patients have tumors positioned in high-risk locations, including mucosal regions or proximity airways, major blood vessels, or spinal cord that may cause occlusion or compression upon tumor swelling or erosion into major vessels due to necrosis or encapsulated major vascular structures like the carotid artery, or adjacent to important neurovascular structures, or other tumors considered unsuitable for intratumoral injection (Part 2);
- Patients requiring any live vaccines during the screening and treatment periods;
- Patients who are allergic to any components of the study drug, immunotherapy or related drugs;
- Patients who have mental illness, alcoholism, failure to quit smoking, drug use or drug abuse;
- Pregnant or breast-feeding women;
- Patients with toxicities (except for alopecia) caused by prior anti-tumor therapies not yet recovered to CTCAE v5.0 Grade 1;
- Patients with serious, uncontrolled diseases or other conditions that may affect the study treatment and are not suitable for this study as assessed by the investigator;
- Patients with other conditions that are not suitable for enrollment in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
About this study
Official title: A Single-Arm, Open-Label, Dose Escalation Phase I Study of OVV-01 Intravenous and Intratumoral Injection to Evaluate the Safety, Tolerability, and Preliminary Efficacy in Patients With Advanced Solid Tumors
This is an open-label, single-arm, dose escalation clinical study to evaluate the safety and preliminary efficacy of OVV-01 Injection in patients with advanced solid tumors, following both intravenous (iv.) and intratumoral (it.) injections. This study consists of two parts: Part 1 is a dose escalation study of iv. administration; Part 2 is a dose escalation study of iv. and it. administration.
- Conditions
- Advanced Solid Tumors
- Being tested
- OVV-01 Injection
- Keywords
- OVV-01, VSV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVV-01 InjectionDrug
Dose group 1: 6×10 10 PFU/subject; Dose group 2: 6×10 11 PFU/subject;
OVV-01 InjectionDrug
Dose group 1: 6×10 10 PFU/mL(it.) + 6×10 10 PFU/subject (iv.); Dose group 2: 6×10 10 PFU/mL(it.) +6×10 11 PFU/subject (iv.);
| Study group | Role | What they receive |
|---|---|---|
| OVV-01 iv. | Active comparator | Dose escalation of iv. administration "3+3" design is adopted to explore the MTD, based on which the RP2D will be determined. Receives: Drug: OVV-01 Injection |
| OVV-01 iv.+it. | Active comparator | Dose escalation of iv.+it. administration "3+3" design is adopted to explore the MTD, based on which the RP2D will be determined. Receives: Drug: OVV-01 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Measured: The DLT observation period for both Route 1 and Route 2 is within the 4 weeks after the first dose.
Secondary outcomes (2)
Objective response rate (ORR)
The investigator will evaluate the tumor response as per RECIST v1.1 criteria
Measured: Tumor response should be assessed every 6 weeks following the first dose, with a final assessment conducted at the end of treatment (28 days after the last treatment).
Disease control rate (DCR)
The investigator will evaluate the tumor response as per RECIST v1.1 criteria
Measured: Tumor response should be assessed every 6 weeks following the first dose, with a final assessment conducted at the end of treatment (28 days after the last treatment).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start21 Apr 2026
- Primary completion20 Apr 2027 (estimated)
- Study completion20 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Part 1: Dose escalation of iv. administration Part 2: Dose escalation of iv.+it. administration
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Biosciences Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648472
- Sponsor's protocol ID
- OVV-01A02
- Status last verified
- Jun 2026
- First submitted
- 7 Jun 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Dose Escalation Phase I Study of OVV-01 Intravenous and Intratumoral Injection to Evaluate the Safety, Tolerability, and Preliminary Efficacy in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07648472
- Acronym / sponsor ID
- OVV-01A02
- Conditions
- Advanced Solid Tumors
- Keywords
- OVV-01, VSV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Joint Biosciences Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Study start
- 21 Apr 2026 (actual)
- Primary completion
- 20 Apr 2027 (estimated)
- Study completion
- 20 Apr 2027 (estimated)
- First posted
- 15 Jun 2026 (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 is an open-label, single-arm, dose escalation clinical study to evaluate the safety and preliminary efficacy of OVV-01 Injection in patients with advanced solid tumors, following both intravenous (iv.) and intratumoral (it.) injections. This study consists of two parts: Part 1 is a dose escalation study of iv. administration; Part 2 is a dose escalation study of iv. and it. administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Part 1: Dose escalation of iv. administration Part 2: Dose escalation of iv.+it. administration
| Arm | Type | Receives |
|---|---|---|
| OVV-01 iv. | Active comparator | Drug: OVV-01 InjectionDose escalation of iv. administration "3+3" design is adopted to explore the MTD, based on which the RP2D will be determined. |
| OVV-01 iv.+it. | Active comparator | Drug: OVV-01 InjectionDose escalation of iv.+it. administration "3+3" design is adopted to explore the MTD, based on which the RP2D will be determined. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing to sign the ICF, be able to understand the study, and be willing to follow the protocol and complete all the study procedures;
- Males or females aged ≥18 years when signing the ICF;
- Patients with advanced solid tumors (including but not limited to melanoma, squamous cell carcinoma of head and neck, cervix carcinoma, bone sarcoma, nasopharyngeal cancer, breast cancer, lung cancer, colorectal cancer, hepatic cancer, and gastric cancer) as histopathologically or cytologically confirmed by primary lesions and/or metastases; Patients with unresectable locally advanced disease will be included, while patients with resectable disease will be excluded.
- Patients who experienced treatment failure to standard of care, have no available standard of care, or are not suitable for standard of care due to medical reasons. Patients need to have progressed on at least two lines of standard of care therapy including but not limited to targeted therapy. For example, patients with metastatic or unresectable advanced melanoma who experienced treatment failure to standard of care such as anti-PD-1 antibody (patients harboring BRAF mutations who experienced treatment failure to BRAF and MEK inhibitors); patients with recurrent or metastatic advanced squamous cell carcinoma of head and neck who may have experienced standard treatment failure approved to anti-PD-1 monoclonal antibody and platinum-based chemotherapy; patients with recurrent or metastatic osteosarcoma who experienced treatment failure to chemotherapy drugs (including high-dose methotrexate, doxorubicin, cisplatin, ifosfamide, etc.); patients with colorectal cancer who have received standard of care fluoropyrimidine, oxaliplatin, Bevacizumab, and irinotecan-based chemotherapy, patients with wild-type KRAS who have received anti-EGFR, and patients with microsatellite instability-high disease who have received at least one prior immune checkpoint inhibitor; patients with breast cancer (including HR positive, HER2 +, and triple negative breast cancer) who have received at least 2 prior lines which should include taxane and/or anthracycline-based therapy where appropriate and an approved checkpoint inhibitor;
- Patients with at least one measurable lesion per RECIST v1.1, i.e., the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to computed tomography (CT) or magnetic resonance imaging (MRI); The patient should also have injected tumor lesions for Part 2, including cutaneous or subcutaneous visible nodal lesions or lesions palpable deemed injectable, and hepatic lesions or non-subcutaneous lymph nodes such as retroperitoneal. These lesions should be deemed feasible for injection either directly (palpable subcutaneous tumors) by a qualified investigator or under CT or ultrasound guidance (based on size, location, and visibility); All injected tumors should be > 1 cm in size;
Key exclusion criteria (24 listed)
- Patients with known brain metastases and/or clinically suspected brain metastases (however, patients with asymptomatic brain metastases or who have been clinically stable for more than 3 months after local treatment can be enrolled);
- Patients who received radiotherapy for the target lesion in the past 2 months;
- Patients with other active malignancies in the past 5 years shall be excluded, with the exceptions for those who are completely cured and do not require follow-up treatment, and those with study indications;
- The longest diameter of the injected lesion is >100 mm for Part 2;
- Patients participated (in the past 4 weeks) or are participating in clinical studies of the other drugs or medical devices;
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 |
|---|---|---|
| OVV-01 InjectionDose group 1: 6×10 10 PFU/subject; Dose group 2: 6×10 11 PFU/subject; | Drug | OVV-01 iv. |
| OVV-01 InjectionDose group 1: 6×10 10 PFU/mL(it.) + 6×10 10 PFU/subject (iv.); Dose group 2: 6×10 10 PFU/mL(it.) +6×10 11 PFU/subject (iv.); | Drug | OVV-01 iv.+it. |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: The DLT observation period for both Route 1 and Route 2 is within the 4 weeks after the first dose.
2 secondary outcomes
Objective response rate (ORR)
Time frame: Tumor response should be assessed every 6 weeks following the first dose, with a final assessment conducted at the end of treatment (28 days after the last treatment).
Disease control rate (DCR)
Time frame: Tumor response should be assessed every 6 weeks following the first dose, with a final assessment conducted at the end of treatment (28 days after the last treatment).
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 15 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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.
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 OVV-01 Injection in people with Advanced Solid Tumors, run by Joint Biosciences 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 10 inclusion and 24 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 15 Jun 2026. 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 Ning Li (01067781331, lining@cicams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: The DLT observation period for both Route 1 and Route 2 is within the 4 weeks after the first dose.). 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 15 Jun 2026.