Advanced Solid TumorsPhase 1NCT07650825
OVV-01 Intravenous and Intratumoral Injection Combined With AK112 for the Treatment of Advanced Solid Tumors
A Phase 1 study testing OVV-01 and AK112 in people with Advanced Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with… 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 and AK112
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 31 Jan 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
- At least 18 years of age at the time of signing the ICF; gender is not restricted.
- Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary and/or metastatic lesions, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, etc.
- Patients with advanced disease who have failed standard therapy, lack standard treatment options, or are medically ineligible for standard therapy. Patients must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies).
- Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions ≥10 mm in longest diameter and lymph node lesions ≥15 mm in shortest diameter on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound/CT/or endoscopic guidance.
- ECOG performance status of 0-1, with an estimated survival of at least 12 weeks.
- Sufficient organ and hematopoietic function.
- Women of childbearing potential must have a negative pregnancy test within 7 days prior to treatment initiation.
- Male and female subjects of childbearing potential must agree to use reliable contraception during the trial and for 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 those clinically stable for over 3 months following local treatment may be enrolled);
- Subjects who underwent radiotherapy to the target lesion within the past 2 months (may be enrolled if the radiotherapy site progressed);
- Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;
- Largest diameter of lesions for injection >100 mm;
- Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;
- Subjects scheduled for or who have previously undergone tissue/organ transplantation;
Show all 11Show fewer
- Subjects with Human Immunodeficiency Virus (HIV) infection who have experienced AIDS-related opportunistic infections within the past 12 months, or who have a CD4+ T-cell (CD4+) count < 350 cells/uL; Patients screening positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection, or screening positive for HCV antibody with HCV-RNA above the lower limit of detection; subjects with positive syphilis serology;
- Subjects requiring antiviral therapy during the study period or within 5 half-lives of the first dose of antiviral therapy.
- Subjects requiring therapeutic anticoagulant therapy during the study period.
- Subjects with uncontrolled active infection ≥ Grade 3 according to CTCAE v5.0 that is clinically significant;
- Received antineoplastic therapy (chemotherapy, radiotherapy, biologic therapy, endocrine therapy, immunotherapy, etc.) within 4 weeks prior to first dose; Received small-molecule targeted therapy or oral fluorouracil-based agents within 2 weeks prior to first dose or within 5 half-lives (whichever is longer); Received Chinese herbal medicine or proprietary Chinese medicine with antitumor indications within 2 weeks prior to the first dose; Received nitrosourea or mitomycin C within 6 weeks prior to the first dose; Palliative radiotherapy for non-target lesions is permitted (≥2 weeks prior to the first dose);
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shuhang Wang, MD contact
About this study
Official title: A Single-Arm, Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of OVV-01 Administered Intravenously and Intratumorally in Combination With AK112 in Patients With Advanced Solid Tumors
This study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.
Read the detailed description
Eligible subjects must have advanced malignant solid tumours that have been confirmed by histology or cytology and possess measurable, injectable tumour lesions, including superficial and deep lesions that can be injected under ultrasound/CT guidance.
The study comprises a screening period, a treatment period and a follow-up period. The screening period runs from the day the subject signs the ICF (Day -28) until the day before the first dose is administered (Day -1). Eligible subjects will receive intravenous (IV) therapy alone or in combination with AK112 (Part 1), or IV therapy plus intratumoral (IT) therapy alone or in combination with AK112 (Part 2). Dosing occurs on Days 1 and 3 (D1 and D3) of each two-week treatment cycle, for up to six cycles. IV and IT injections are administered on the same day. If a DLT occurs during the DLT observation period, OVV-01 administration will be discontinued. Treatment will continue until disease progression occurs, the subject develops intolerable toxicity, the subject withdraws informed consent, the subject dies or is lost to follow-up, the investigator determines that termination is in the subject's best interests, or the subject completes six consecutive cycles, whichever occurs first.
- Conditions
- Advanced Solid Tumors
- Being tested
- OVV-01, AK112
- Keywords
- oncolytic virus, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVV-01Drug
OVV-01 is administered twice every two weeks
AK112Drug
AK112 is administered once every two weeks.
| Study group | Role | What they receive |
|---|---|---|
| OVV-01 intravenous injection | Experimental | OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; Upon enrollment of 3 subjects in the OVV-01 monotherapy intravenous group with no DLT events, the combination therapy group may be initiated; In the combination therapy group, OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered. Receives: Drug: OVV-01; Drug: AK112 |
| OVV-01 IV + IT | Experimental | OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; intratumoral injection and intravenous injection are completed on the same day.
The OVV-01 monotherapy intravenous group may initiate the combination therapy group once 3 subjects are enrolled and no DLT events occur.
For the combination therapy group: OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered. Intratumoral injection and intravenous injection are completed on the same day. Receives: Drug: OVV-01; Drug: AK112 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
According to the internationally accepted CTCAE v5.0 toxicity grading criteria, DLT in this study is defined as a toxicity reaction related to the study drug OVV-01 occurring within 3 weeks after the first dose.
Measured: Within 21 days after administration
Incidence of Adverse Events (AEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
Measured: From signing ICF until 24 months after the last infusion.
Secondary outcomes (5)
ORR
The proportion of subjects achieving CR or PR will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
DCR
The proportion of subjects achieving CR, PR, or SD will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
DoR
Assessment will be conducted according to RECIST 1.1. For subjects achieving objective response, DOR is defined as the time from the first documented objective tumor response (CR or PR) to the first documented disease progression or death from any cause, whichever occurs first.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
PFS
The time from the first study treatment to the first documented disease progression or death from any cause (whichever occurs first) will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
OS
The time from the first study treatment to death from any cause will be assessed according to RECIST 1.1.
Measured: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 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.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ning Li, Study chair, Chief, Office of Clinical Trial Center, CancerIHCAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07650825
- Sponsor's protocol ID
- OVV-01A07
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label Clinical Study Evaluating the Safety, Tolerability, and Preliminary Efficacy of OVV-01 Administered Intravenously and Intratumorally in Combination With AK112 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07650825
- Acronym / sponsor ID
- OVV-01A07
- Conditions
- Advanced Solid Tumors
- Keywords
- oncolytic virus, immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 16 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 study is an open-label, multiple-route-of-administration dose-escalation clinical trial designed to evaluate the safety and preliminary efficacy of OVV-01 injection administered intravenously or intravenously plus intratumorally, either as monotherapy or in combination with AK112 injection, in subjects with advanced solid tumors.
Detailed description
Eligible subjects must have advanced malignant solid tumours that have been confirmed by histology or cytology and possess measurable, injectable tumour lesions, including superficial and deep lesions that can be injected under ultrasound/CT guidance.
The study comprises a screening period, a treatment period and a follow-up period. The screening period runs from the day the subject signs the ICF (Day -28) until the day before the first dose is administered (Day -1). Eligible subjects will receive intravenous (IV) therapy alone or in combination with AK112 (Part 1), or IV therapy plus intratumoral (IT) therapy alone or in combination with AK112 (Part 2). Dosing occurs on Days 1 and 3 (D1 and D3) of each two-week treatment cycle, for up to six cycles. IV and IT injections are administered on the same day. If a DLT occurs during the DLT observation period, OVV-01 administration will be discontinued. Treatment will continue until disease progression occurs, the subject develops intolerable toxicity, the subject withdraws informed consent, the subject dies or is lost to follow-up, the investigator determines that termination is in the subject's best interests, or the subject completes six consecutive cycles, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OVV-01 intravenous injection | Experimental | Drug: OVV-01, Drug: AK112OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; Upon enrollment of 3 subjects in the OVV-01 monotherapy intravenous group with no DLT events, the combination therapy group may be initiated; In the combination therapy group, OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered. |
| OVV-01 IV + IT | Experimental | Drug: OVV-01, Drug: AK112OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, with a 2-week treatment cycle lasting up to 6 cycles; intratumoral injection and intravenous injection are completed on the same day. The OVV-01 monotherapy intravenous group may initiate the combination therapy group once 3 subjects are enrolled and no DLT events occur. For the combination therapy group: OVV-01 injection is administered on Day 1 and Day 3 (D1, D3) of each cycle, while AK112 is administered on Day 1 (D1) of each cycle. Each treatment cycle spans 2 weeks, with a maximum of 6 cycles administered. Intratumoral injection and intravenous injection are completed on the same day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- At least 18 years of age at the time of signing the ICF; gender is not restricted.
- Patients with advanced solid tumors confirmed by histopathological/cytological examination of the primary and/or metastatic lesions, including but not limited to: melanoma, head and neck squamous cell carcinoma, cervical cancer, osteosarcoma, nasopharyngeal carcinoma, breast cancer, lung cancer, colorectal cancer, hepatocellular carcinoma, gastric cancer, etc.
- Patients with advanced disease who have failed standard therapy, lack standard treatment options, or are medically ineligible for standard therapy. Patients must have progressed after receiving at least two standard therapies (including but not limited to targeted therapies).
- Subjects must have at least one measurable lesion as defined by RECIST 1.1 criteria, i.e., non-lymph node lesions ≥10 mm in longest diameter and lymph node lesions ≥15 mm in shortest diameter on CT or MRI. Injectable tumor lesions must be present, including superficial lesions and deep lesions amenable to injection under ultrasound/CT/or endoscopic guidance.
- ECOG performance status of 0-1, with an estimated survival of at least 12 weeks.
Key exclusion criteria (11 listed)
- Patients with known brain metastases and/or clinically suspected brain metastases (however, patients with asymptomatic brain metastases or those clinically stable for over 3 months following local treatment may be enrolled);
- Subjects who underwent radiotherapy to the target lesion within the past 2 months (may be enrolled if the radiotherapy site progressed);
- Subjects with other active malignancies within the past 5 years. Exceptions include subjects who have achieved complete remission and require no follow-up treatment, or subjects with malignancies within the scope of the indication;
- Largest diameter of lesions for injection >100 mm;
- Subjects who have participated in or are currently participating in other drug or medical device clinical trials within the past 4 weeks;
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-01OVV-01 is administered twice every two weeks | Drug | OVV-01 IV + IT, OVV-01 intravenous injection |
| AK112AK112 is administered once every two weeks. | Drug | OVV-01 IV + IT, OVV-01 intravenous injection |
Primary outcome
DLT
Time frame: Within 21 days after administration
According to the internationally accepted CTCAE v5.0 toxicity grading criteria, DLT in this study is defined as a toxicity reaction related to the study drug OVV-01 occurring within 3 weeks after the first dose.
Incidence of Adverse Events (AEs)
Time frame: From signing ICF until 24 months after the last infusion.
Incidence and severity of treatment-emergent adverse events (TEAEs) graded according to NCI CTCAE v5.0.
5 secondary outcomes
ORR
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
DCR
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
DoR
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
PFS
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 months.
OS
Time frame: Imaging assessments will be conducted within 28 days prior to first dose, every 6 weeks (±7 days) during treatment, and every 12 weeks during follow-up until disease progression，up to 24 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 16 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Shuhang Wang, MD contact
Ning Li study chair
Chief, Office of Clinical Trial Center, CancerIHCAMS
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 and AK112 in people with Advanced Solid Tumors, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 inclusion and 11 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 16 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 Yanjie Han, MD (+86010-87788165, annyhan_1997@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Within 21 days after 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?
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 16 Jun 2026.