ClinicalTrials.gg
RecruitingNCT07697937YH02Updated Jul 13, 2026

YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases

A Phase 2 interventional study of YH-02 in Advanced Malignant Solid Tumor, sponsored by Tianjin First Central Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.

Sponsored by Tianjin First Central Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and genetically modifying the capsid protein, the virus's permeability, tumor targeting capability, and infection efficiency were significantly enhanced. Preclinical pharmacodynamic studies demonstrated that YH02 exhibits potent tumor growth inhibitory effects in various human-and murine-derived solid tumor models (including breast cancer, liver cancer, and melanoma). Given that oncolytic virus therapies already have approved products with demonstrated safety and efficacy worldwide, this study may offer potential clinical benefits for patients with advanced solid tumors who have failed standard treatments.

YH02 injection has undergone an open-label, dose-escalating, and expanded Phase I clinical study in China aimed at evaluating the safety, tolerability, biodistribution characteristics, viral clearance, and immunogenicity of intratumoral administration of YH02 injection in patients with advanced solid tumors who have failed adequate standard therapy and lack effective treatment options, while preliminarily investigating its efficacy. No high-grade adverse drug reactions (ADRs) have been observed to date, nor were there any serious adverse events (SAEs), severe adverse drug reactions (SUSARs), or fatal events. The clinical safety and tolerability of this product for intratumoral administration are favorable.

Read the detailed description

Cancer is a disease that poses a serious threat to human health and social development. The International Agency for Research on Cancer (IARC) of the World Health Organization released the latest global cancer burden data for 2020. In 2020, there were 19.29 million new cancer cases worldwide, among which China accounted for 4.57 million cases, representing 23.7% globally. The number of cancer-related deaths worldwide reached 9.96 million in 2020, with China contributing 3 million deaths, accounting for 30% of total cancer-related fatalities. Data indicate that malignant tumor deaths account for 23.91% of all causes of death among residents, and annual medical expenditures due to malignant tumors exceed $220 billion, imposing a significant burden on patients and their families, healthcare systems, and society as a whole. Over the past decade, the cancer burden has shown a sustained upward trend, with the incidence rate of malignant tumors increasing by approximately 3.9% annually and the mortality rate rising by 2.5% annually. Furthermore, globally, due to accelerating population aging, the cancer burden is projected to increase by 50% by 2040 compared to 2020, with the number of new cancer cases reaching nearly 30 million.

In recent years, tumor immunotherapy has become a pivotal approach in cancer treatment, standing alongside chemotherapy, targeted therapy, surgery, and radiotherapy. Particularly, immune checkpoint inhibitors (ICIs) have achieved remarkable clinical success. However, overall, the response rates to these therapies remain limited and require further improvement. Tumors that respond to ICI are termed immunologically "hot tumors," whereas those that do not respond are referred to as "cold tumors." Since German scientist Jean Rommelaere first described oncolytic virus therapy as tumor immunotherapy in a 2011 publication, oncolytic viruses have gained widespread acceptance as a key branch of tumor immunotherapy. The use of oncolytic viruses to convert "cold tumors" into "hot tumors" is recognized as an effective strategy .

Oncolytic viruses possess multiple functions, including direct killing of tumor cells, induction of immune responses, and enhancement of the efficacy of other antitumor agents. Compared to conventional treatment approaches, they offer distinct advantages such as high specificity, minimal side effects, and broad efficacy against various tumor types. Oncolytic viruses are a class of naturally occurring or genetically engineered viruses capable of targeting and destroying tumor cells. The primary oncolytic viruses currently employed in cancer research include herpes simplex virus, adenovirus, and vaccinia virus. These viruses achieve specific targeting of tumor cells and self-replication by leveraging various mechanisms: abnormal expression of surface receptors, defects in surface molecules, alterations in signaling pathways within tumor cells, deletion of genes essential for viral replication in normal cells but non-essential in tumor cells, and placement of replicative genes under the control of specific promoters. This enables tumor cell lysis and death, with released viruses initiating new infection cycles. Additionally, lysed tumor cells release abundant tumor antigens, activating specific antitumor immunity to recognize and attack uninfected tumor cells. Furthermore, upon entering the body, oncolytic viruses stimulate antiviral immunity, reverse the suppressive state of immune cells in the tumor microenvironment, and redirect immune attacks toward tumor cells. Finally, oncolytic viruses can deliver therapeutic molecules or be combined with other therapies to enhance antitumor efficacy.

Human adenovirus was first isolated in 1953 from the tonsils of infants with respiratory infections. Adenoviruses can infect various mucosal tissues, including the gastrointestinal tract, respiratory system, urogenital tract, and conjunctiva [14]. Adenoviral vectors are widely used in research on prevention and treatment of genetic disorders, cancers, and infectious diseases; in addition to the commonly employed adenovirus type 5 vector, multiple other serotype adenovirus vectors have been developed. Adenovirus is an envelope-free, twenty-faced symmetrical linear double-stranded DNA virus classified by the International Commission on Viral Classification into groups A-G7 comprising 52 serotypes .Oncolytic adenoviruses, also known as conditionally replicating adenoviruses (CRADs), are genetically engineered adenoviruses capable of selectively replicating within tumor cells, ultimately causing their lysis while causing minimal damage to normal cells. The most widely used oncolytic adenoviruses belong to subtypes 2 and 5 of the Adenovirus genus within the Adenoviridae family , both classified serologically as Group C. These are enveloped double-stranded DNA viruses with a twenty-faced symmetrical structure, featuring fibrin-based cilia on their capsid surface whose size and quantity are species-specific, playing a role in receptor cell adhesion and binding. The infection process involves several key steps: first, viral particles bind to specific receptors on the host cell membrane, primarily the Coxsackievirus receptor (CAR); subsequently, they interact with integrins, enter cells via endocytosis, and shed their capsids; finally, viral DNA is released into the nucleus through nuclear pores for transcription and replication. Due to their ability to selectively replicate in tumor cells and deliver exogenous genes for expression therein, oncolytic adenoviruses have garnered significant attention in oncology therapy and represent a promising novel approach for cancer treatment. However, the use of recombinant oncolytic adenoviruses alone did not achieve the expected therapeutic efficacy; consequently, further modification of oncolytic adenoviruses has become a new research focus.

In clinical research on oncolytic adenovirus-based cancer gene therapy, the United States leads the world in this field, with several of its oncolytic adenovirus products having entered the clinical stage. Clinical studies have demonstrated that oncolytic adenovirus-based therapies will become a highly promising area of focus for future cancer gene therapy. In 2003 and 2005, China's National Medical Products Administration approved two adenovirus-based products for market release: "Jinyousheng" by Shenzhen Sainuo and "Ankerui" by Shanghai Sanwei Biotech. Clinical trials conducted with Ankerui across various solid tumors indicated favorable safety profiles and certain therapeutic efficacy when administered via intratumoral injection or pleural perfusion for treating nasopharyngeal carcinoma, hepatocellular carcinoma, pancreatic cancer, among others . Currently, most oncolytic virus drug development in China relies primarily on purchased or imported generic versions, with few companies possessing comprehensive independent design capabilities or robust R\&D capacities; overall, the design quality remains relatively low, and most products exhibit insufficient therapeutic efficacy.The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and genetically modifying the capsid protein, the virus's permeability, tumor targeting capability, and infection efficiency were significantly enhanced. Preclinical pharmacodynamic studies demonstrated that YH02 exhibits potent tumor growth inhibitory effects in various human-and murine-derived solid tumor models (including breast cancer, liver cancer, and melanoma). Given that oncolytic virus therapies already have approved products with demonstrated safety and efficacy worldwide, this study may offer potential clinical benefits for patients with advanced solid tumors who have failed standard treatments.

YH02 injection has undergone an open-label, dose-escalating, and expanded Phase I clinical study in China aimed at evaluating the safety, tolerability, biodistribution characteristics, viral clearance, and immunogenicity of intratumoral administration of YH02 injection in patients with advanced solid tumors who have failed adequate standard therapy and lack effective treatment options, while preliminarily investigating its efficacy. No high-grade adverse drug reactions (ADRs) have been observed to date, nor were there any serious adverse events (SAEs), severe adverse drug reactions (SUSARs), or fatal events. The clinical safety and tolerability of this product for intratumoral administration are favorable.

02

Conditions studied

  • Advanced Malignant Solid Tumor

Keywords

  • advanced solid tumors
  • oncolytic virus
  • adenovirus
  • intratumor
03

In context

Adenoviridae Infections

136 studies on the registry are indexed under Adenoviridae Infections; 34 are open to participants now.

This study's planned enrollment of 50 is above the median of 30 across 109 interventional studies indexed under Adenoviridae Infections.

Browse Adenoviridae Infections studies →

Lead sponsor

Tianjin First Central Hospital is the lead sponsor of 18 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: ≥18 years.
  • Resectable malignant solid tumors confirmed by histology or cytology (including head and neck cancer, breast cancer, melanoma, cervical cancer, skin , salivary gland carcinoma, oropharyngeal carcinoma, etc.) should prioritize treatment options for head and neck cancer, breast cancer, and melanoma.
  • After complete failure of standard treatment (disease progression or intolerance to therapy) and in the absence of effective therapeutic options.
  • There must be at least one (according to the 1.1 criteria), and the lesion must be suitable for intratumoral injection.
  • score ≤2.
  • The expected survival period is ≥12 weeks.
  • The subject must demonstrate adequate hematological and organ function, with all laboratory parameters evaluated within 7 days prior to the initial administration and meeting the following criteria: Hematologic system (no recent transfusion or hematopoietic stimulation therapy within 14 days): ≥ 1.5 × 10⁹/L; ≥ 80 × 10⁹/L; (Hb) ≥ 85 g/L; Liver function: Total (TBIL) ≤ 2 × (ULN) (≤ 3.0 × ULN for patients with Gilbert syndrome or liver /hepatocellular carcinoma); (ALT) ≤ 2.5 × ULN; For patients with liver metastases or hepatocellular carcinoma: ALT ≤ 5 × ULN; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Albumin ≥ 2.8 g/dL; Renal function: Creatinine ≤ 1.5 × ULN; or (Ccr) ≥ 30 mL/min (calculated using the Cockcroft-Gault formula, only when creatinine> 1.5 × ULN); Coagulation function: (APTT) ≤ 1.5 × ULN; International normalized ratio (INR) or Prothrombin time (PT) ≤ 1.5 × ULN.
  • The subject has voluntarily signed an form and demonstrates good compliance.

Exclusion criteria

Exclusion Criteria:

  • Patients had received antitumor therapy for the first time within 4 weeks prior to initial administration, including endocrine therapy, chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine-based antitumor treatment; or had participated in other clinical trials within 4 weeks before enrollment.

Development of any other malignant tumor other than the study tumor within 5 years prior to first use of the drug, excluding locally advanced cancers that have been completely cured or are disease-free for at least 5 consecutive years, such as basal or squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast ductal carcinoma in situ.

  • The adverse effects of previous antitumor treatments have not yet been classified as Grade ≤1 on the v5.0 grading scale (excluding toxicities such as alopecia and grade 2 neurotoxicity induced by prior platinum-based therapy, which researchers consider to pose no safety risks).
  • Receiving systemic (prednisone>10 mg/day or equivalent doses of similar agents) or other therapies within 2 weeks prior to initial use of the study drug, excluding the following: topical, ocular, intra-articular, intranasal, or inhaled glucocorticoid therapy; short-term (≤1 week) prophylactic use of glucocorticoids (e.g., for contrast agent allergy) or for treatment of non- diseases (e.g., delayed reactions induced by contact allergens).
  • Immuno-modulatory drugs, including but not limited to thymosin, IL-2, and interferon (IFN), were administered within 2 weeks prior to the first administration of the study drug.
  • A syndrome characterized by autoimmune diseases (excluding well-controlled hypothyroidism). Patients with vitiligo, type 1 diabetes mellitus, or psoriasis who do not require systemic treatment and have no history of recurrence in the absence of external triggers are eligible for inclusion.
  • A was administered within 4 weeks prior to the first use of the study drug.
  • Has previously received oncolytic virus therapy or other gene-based therapies.
  • Patients had undergone major surgical procedures or suffered severe trauma within 4 weeks prior to enrollment, or were expected to undergo significant surgery during the study period; furthermore, before the first administration of the investigational drug, all adverse events (AEs) related to surgery or major trauma had not resolved to CTCAE level ≤1 or baseline levels.
  • Patients with clinical manifestations of or meningeal , or other evidence indicating that the patient's CNS or meningeal metastatic lesions are not under control, shall be deemed unsuitable for enrollment by the investigator. Patients with clinical symptoms suggestive of brain or meningeal disease require computed tomography (CT) or magnetic resonance imaging (MRI) examination.
  • For patients with previously treated brain metastases, inclusion may be considered if their clinical condition is stable within 4 weeks prior to enrollment, there is no evidence of new lesions or lesion progression, and they have not received glucocorticoid therapy within 1 week before the first administration.
  • Has a medical history of leptomeningitis.
  • Patients with a history or evidence of high-risk cardiovascular disease are eligible, including but not limited to: severe cardiac rhythm or conduction abnormalities (e.g., ventricular arrhythmias requiring clinical intervention, grade II-III atrioventricular block), a Fridericia formula- interval (QTcF) ≥ 470 msec; acute coronary syndrome (including acute myocardial infarction and unstable angina), stroke, or other grade 3 or higher cardiovascular events occurring within 6 months prior to first administration; stent implantation within 6 months before initial use of the study drug; congestive heart failure classified as grade ≥ II according to the (NYHA) criteria; echocardiographic findings of valvular morphological abnormalities (grade ≥ 2); note: patients with grade 1 valvular morphological abnormalities (e.g., mild regurgitation/stenosis) may be enrolled, but those with moderate valve thickening are excluded; (LVEF) \<the institutional lower limit (or LVEF \<50% if no such limit exists); or poorly controlled blood pressure despite antihypertensive therapy (i.e., systolic blood pressure ≥ 160 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg).
  • Virological tests: Positive for virus surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with hepatitis B virus (HBV) DNA level> upper limit of detection (); positive for virus antibody (HCV-Ab) with hepatitis C virus (HCV) RNA level> ULN; positive for anti- antibody (Anti-HIV). Meeting any of the above criteria.
  • Had an active infection requiring systemic treatment (intravenous administration) within 2 weeks prior to the first use of the investigational drug, excluding local treatments.

Patients known to have allergic reactions to any component of the YH02 injection formulation.

  • Individuals with known mental disorders that may affect research compliance or substance abuse.
  • Patients who have undergone or plan to undergo organ transplantation (e.g., liver transplantation).
  • Patients who, according to the investigators' assessment, have other severe systemic diseases, abnormal laboratory findings, or other reasons that make them unsuitable for participation in this clinical study.
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    advanced solid tumors

    Drug: YH-02

Interventions

  • DrugYH-02

    The preclinical pharmacological mechanism of YH02 injection is well established. By constructing a vector expressing MMP13, introducing a human S promoter, and performing genetic modifications to the capsid protein, the drug significantly enhances viral permeability, tumor targeting capability, and infection efficiency.

06

What researchers measure

Primary outcomes

  1. duration of response

    Time frame: 12 months

  2. objective response rate

    Time frame: 3 months

  3. disease control rate

    Time frame: 12 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jun 2026 (actual). Primary completion is estimated for May 2028, 23 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Jul 13, 2026
StartActual
Jun 23, 2026
Primary completionEst.
May 31, 2028
CompletionEst.
Jul 31, 2028
Last update
Jul 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07697937
Lead sponsor
Tianjin First Central Hospital
Responsible party
Zhigang Zhao (The director of the Oncology Department of Tianjin First Central Hospital, Tianjin First Central Hospital) — Principal investigator
First posted
Jul 13, 2026
Start date
Jun 23, 2026
Primary completion
May 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Jul 13, 2026

Study contacts

Shanshan XU
Contact
xushan1012@tmu.edu.cn
+86 15690533960

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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