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New treatment option for Advanced Malignant Solid Tumor
Official title YH02 Injection for Intra-tumor Injection Therapy in Advanced Solid Tumors With Unresponsive or Failure-Treated Cases
ClinicalTrials.gov ID: NCT07697937
What this study is testing
What is YH-02?
YH-02 is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for advanced malignant solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: ≥18 years.
- Resectable malignant solid tumors confirmed by histology or cytology (including head and neck cancer, breast cancer, melanoma, cervical cancer, skin...
- 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 measurable lesion (according to the RECIST 1.1 criteria), and the lesion must be suitable for intratumoral injection.
- ECOG score ≤2.
You likely can't join if
- Patients had received antitumor therapy for the first time within 4 weeks prior to initial administration, including endocrine therapy, chemotherapy...
- The adverse effects of previous antitumor treatments have not yet been classified as Grade ≤1 on the NCI CTCAE v5.0 grading scale (excluding...
- Receiving systemic glucocorticoids (prednisone\>10 mg/day or equivalent doses of similar agents) or other immunosuppressive therapies within 2 weeks...
- Immuno-modulatory drugs, including but not limited to thymosin, IL-2, and interferon (IFN), were administered within 2 weeks prior to the first...
- A syndrome characterized by clinically significant autoimmune diseases (excluding well-controlled hypothyroidism). Patients with vitiligo, type 1...
- A live attenuated vaccine was administered within 4 weeks prior to the first use of the study drug.
See the full eligibility criteria
- Age: ≥18 years.
- Resectable malignant solid tumors confirmed by histology or cytology (including head and neck cancer, breast cancer, melanoma, cervical cancer, skin malignancies, salivary gland carcinoma, oropharyngeal carcinoma, etc.)...
- 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 measurable lesion (according to the RECIST 1.1 criteria), and the lesion must be suitable for intratumoral injection.
- ECOG 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...
- The subject has voluntarily signed an informed consent form and demonstrates good compliance.
- 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...
- The adverse effects of previous antitumor treatments have not yet been classified as Grade ≤1 on the NCI CTCAE v5.0 grading scale (excluding toxicities such as alopecia and grade 2 neurotoxicity induced by prior...
- Receiving systemic glucocorticoids (prednisone\>10 mg/day or equivalent doses of similar agents) or other immunosuppressive therapies within 2 weeks prior to initial use of the study drug, excluding the following...
- 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 clinically significant autoimmune diseases (excluding well-controlled hypothyroidism). Patients with vitiligo, type 1 diabetes mellitus, or psoriasis who do not require systemic treatment and...
- A live attenuated vaccine 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...
- Patients with clinical manifestations of CNS metastasis or meningeal metastasis, or other evidence indicating that the patient's CNS or meningeal metastatic lesions are not under control, shall be deemed unsuitable for...
- 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...
- 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...
- Virological tests: Positive for hepatitis B virus surface antigen (HBsAg); positive for hepatitis B core antibody (HBcAb) with hepatitis B virus (HBV) DNA level\> upper limit of detection (ULN); positive for hepatitis C...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.