Malignant TumorPhase 1NCT06080984

The Application of Novel Oncolytic Virus in Late Stage Solid Tumors

A Phase 1 study testing Oncolytic Virus SDJ001 and Oncolytic Virus YD06-1 in people with Malignant Tumor, run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to evaluate the efficacy and safety of novel oncolytic virus in late stage solid tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Malignant Tumor
What is being tested?: Oncolytic Virus SDJ001 and Oncolytic Virus YD06-1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteChina
Study dates: 15 Oct 2023to 15 Oct 2025
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female patients: ≥18 years.
a)Patients with confirmed advanced squamous cell carcinoma of the head and neck (including nasopharynx) who meet the following criteria: Patients who have failed standard second-line treatment. Tumors that cannot be cured through local treatment (surgery or definitive radiation therapy).
b)Patients with stage III malignant melanoma who are not eligible for surgical resection, or patients with stage IV malignant melanoma, who have failed at least two lines of standard treatment (including chemotherapy, immunotherapy or targeted therapy).
c)Patients with locally unresectable or metastatic advanced soft tissue sarcomas, who have failed prior systemic treatments.
ECOG performance status score: 0-1.
Expected survival ≥3 months.

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Time since the last chemotherapy/radiotherapy/surgery is more than 28 days.
Adequate organ function, as defined by the following criteria within 14 days before enrollment:
Hematology: Hemoglobin ≥90g/L (without blood transfusion in the last 14 days); Neutrophil count >1.5×10^9/L; Platelet count ≥80×10^9/L.
Biochemistry: Total bilirubin ≤1.5×ULN (upper limit of normal); Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5×ULN; if there is liver metastasis, ALT or AST ≤5×ULN; Estimated glomerular filtration rate ≥60ml/min (Cockcroft-Gault formula).
Cardiac Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) ≥50%.
Patients with injectable lesions (those suitable for direct injection or injection with the assistance of medical imaging), defined as follows: at least one injectable lesion in the skin, mucous membrane, subcutaneous tissue, or lymph node with a longest diameter ≥10 mm, or multiple injectable lesions with a total longest diameter ≥10 mm
No continuing acute toxic effects of any prior radiotherapy, chemotherapy, or surgical intervention, i.e., all such effects must have resolved to Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) Grade 1.
Signed written informed consent Subjects must sign a written informed consent form approved by the competent authority and the research institution and date it. The informed consent form must be signed before any protocol-related procedures (not part of the subject's routine medical care) are conducted.
Subjects must be willing and able to comply with the scheduled visits, treatment regimen, laboratory tests, and other requirements of the study.

Who cannot join

Participated in another drug clinical trial within the past 4 weeks.
Tumor located near major blood vessels or the trachea.
Has poorly controlled clinical heart symptoms or diseases, such as NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within the past year, clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention.
For female subjects: pregnant or lactating women.
Persistent or active infections, including but not limited to: active pulmonary tuberculosis, positive HIV (Human Immunodeficiency Virus) antibodies, positive HBsAg (Hepatitis B Surface Antigen), positive HBcAb (Hepatitis B Core Antibody), and positive HCV (Hepatitis C Virus) antibody test results.
Participants who are positive for HBsAg and/or HBcAb must also provide baseline HBV DNA results and undergo HBV DNA monitoring during the treatment according to the protocol.

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Participants with HBV DNA results of 10^4 copies/ml or ≥ 2000 IU/mL and any of the following conditions should be excluded: 1) positive results for HBsAg and/or HBeAg; 2) positive results for HBcAb and negative results for all others.
Patients with a positive HCV antibody test result are only ineligible for study participation if their HCV RNA test result is positive..
Has a history of substance abuse that cannot be discontinued or has psychiatric disorders.
Has any active autoimmune disease or a history of autoimmune disease, including but not limited to uveitis, enteritis, pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or childhood asthma that has completely resolved in adulthood without the need for intervention may be included; subjects with asthma requiring bronchodilators for medical intervention cannot be included.
Patients who have used systemic corticosteroids (>10g/day of prednisone or an equivalent dose) or other immunosuppressive drugs in the 4 weeks prior to the initial administration of the study drug will be excluded.
Has a history of substance abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug abuse.
Known allergy, hypersensitivity reaction, or intolerance to oncolytic virus research (including any excipients). A history of severe allergies to any drugs, foods, or vaccines, such as anaphylactic shock, angioedema, respiratory distress, purpura, thrombocytopenic purpura, or localized allergic necrotizing reaction (Arthus reaction), etc.
Female subjects with pregnancy plans during the screening period or male subjects with partners who have pregnancy plans.
Has accompanying diseases judged by the investigator to be seriously harmful to patient safety or affecting the patient's completion of the study.
Patients who have undergone major surgery other than diagnosis or have unhealed wounds, ulcers, or fractures within the 28 days prior to the initial administration of the investigational drug will be excluded. For patients with lesion rupture, screening may be considered, and the eligibility will be jointly assessed by the investigator and the sponsor, depending on the specific circumstances of the rupture. The injection site should be as far away from the rupture site as possible, and during the treatment period, rupture-related adverse events should not be recorded as investigational drug-related adverse events.
During the course of the study, the use of drugs against HSV, including but not limited to acyclovir, valacyclovir, penciclovir, famciclovir, ganciclovir, foscarnet, and cidofovir, may be required.
Patients with episodes of oral herpes (cold sores) may present with small, bead-like, tense vesicles on or around the lips during the initial outbreak, typically measuring approximately 0.5 to 1.5 centimeters in size. These vesicles may also appear in the nose, ear, or finger areas and are often associated with significant pain. Recurrent oral herpes typically presents as ulcers above the vermilion border of the lip (lip herpes) and occasionally as ulcers above the hard palate mucosa.

Trial locations and contacts

1 site in 1 country.

Xingchen Peng contact

+86 18980606753

pxx2014@163.com

China1 site, 1 recruiting

West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Xingchen Peng, +86 18980606753, pxx2014@scu.edu.cn
Recruiting

Other trials in China

About this study

The purpose of this study is to evaluate the efficacy and safety of novel oncolytic virus in late stage solid tumors.

Read the detailed description

Oncolytic viruses (OVs) are naturally occurring or recombinant viruses that can selectively destroy tumor cells without harming normal cells. After infecting the host, oncolytic viruses can replicate within host cells, and the progeny viruses released can further infect neighboring host cells and kill the tumor while triggering local or systemic anti-tumor immune responses. Compared to traditional treatments, oncolytic virus therapy offers advantages such as good targeting, minimal adverse reactions, multiple tumor-killing pathways, and reduced likelihood of developing resistance.

Several clinical studies have found that oncolytic viruses can provide clinical benefits to patients with different types, stages, and even advanced metastatic tumors. Importantly, when used in combination with radiation therapy or chemotherapy, they exhibit good synergistic effects. Especially when used in combination with immunotherapy, oncolytic viruses can sensitize tumor types that were initially unresponsive to immune checkpoint inhibitors.

Currently, oncolytic viruses are believed to exert anti-tumor activity through three main mechanisms:

Direct Oncolytic Effect: Oncolytic viruses can undergo specific replication within tumor cells, primarily due to the tumor's specific genetic alterations that prevent the cell's signaling pathways from sensing and blocking virus replication. Tumor interferon defects prevent the regulation of the virus defense system, increasing sensitivity to virus infection. By genetic modification, the virulence factors of oncolytic viruses can be weakened or deleted, preventing virus replication in normal tissues while retaining the ability to replicate within tumor cells and kill them.
Elicitation of Anti-Tumor Immune Responses: Oncolytic virus infection of tumor cells can transform "cold" tumors into "hot" tumors, thereby triggering local and systemic anti-tumor immune responses. Immune suppressive factors in the tumor microenvironment, such as regulatory lymphocytes, interleukin-10 (IL-10), and programmed death-ligand 1 (PD-L1), can protect tumors from immune surveillance. Oncolytic viruses disrupt the existing tissue structure in the tumor microenvironment and can reverse the immunosuppressive microenvironment, transitioning it from immune suppression to immune activation. After oncolytic virus infection of tumor cells, cell lysis occurs, releasing tumor-associated antigens, activating dendritic cells, increasing the infiltration of cytotoxic T lymphocytes, and recruiting other immune-related cells and molecules. This results in an increase in tumor-specific immune responses, leading to the clearance of distant and uninfected tumor cells.
Expression of Anti-Tumor Target Genes and Anti-Angiogenesis:

Through genetic engineering, oncolytic viruses can express target genes that have anti-tumor effects, such as P53, GM-CSF, IL-12, IL-15, anti-PD-L1, etc., further enhancing their anti-tumor effects. In addition, some oncolytic viruses can infect and destroy the tumor's vascular system, inducing neutrophil infiltration, leading to vascular collapse and tumor cell death.

Oncolytic viruses (OVs) can be categorized into DNA virus carriers and RNA virus carriers based on the type of nucleic acid in their genomes. DNA viruses mainly include herpes simplex virus (HSV), adenovirus (AdV), vaccinia virus (VV), and parvovirus H1; while RNA viruses mainly include reovirus (RV), Coxsackievirus (CV), poliovirus (PV), measles virus (MV), Newcastle disease virus (NDV), and vesicular stomatitis virus (VSV). Among them, the five most commonly used oncolytic viruses in clinical research are adenovirus, HSV-1, reovirus, vaccinia virus, and Newcastle disease virus.

To date, five oncolytic virus products have been approved for marketing globally. There are hundreds of projects in clinical trial stages, especially in recent years, new generations of oncolytic viruses developed and marketed or in clinical stages have shown better safety and stronger anti-tumor capabilities.

Our project team has isolated and modified multiple strains of genetically engineered oncolytic herpes viruses, selecting the best strains for in vivo and in vitro pharmacological and safety evaluations. We have achieved anti-tumor effects superior to currently approved oncolytic virus control drugs. This virus has been engineered to delete virulence factors that are toxic to normal cells, and genetic engineering modifications have been made at multiple genomic loci. It can selectively replicate in tumor cells and can express recombinant bispecific antibodies at high levels. Compared to existing oncolytic virus formulations, this virus demonstrates improved safety and anti-tumor activity and holds great promise for clinical translation. In preliminary studies, the project team has also demonstrated significant anti-tumor effects of oncolytic adenovirus expressing this bispecific antibody. Therefore, in this clinical trial, our project team plans to conduct clinical translational research using the original strain based on proprietary intellectual property that has undergone genetic engineering improvements.

The implementation of this project will provide a highly potential and hopeful clinical treatment strategy for advanced cancer patients with no other treatment options. It will also provide new ideas, strategies, and experimental evidence for the development of oncolytic virus new drugs.

Conditions: Malignant Tumor
Being tested: Oncolytic Virus SDJ001, Oncolytic Virus YD06-1
Keywords: Solid Tumors, Oncolytic Virus
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 SDJ001Drug
Patients in the study receive intratumoral treatment with SDJ001 at two dose levels: 5x10^11 and 1x10^12 pfu per person. At the current dose levels, intratumoral injection is administered on the first day of each treatment cycle. Each treatment cycle consists of three weeks, continuing until tumor growth is observed following injection or until the patient experiences intolerable toxic effects.
Ultrasound-guided injection may be used when necessary (2.0 mL for tumors with a diameter >2.5 cm, 1.0 mL for diameters of 1.5-2.5 cm, 0.5 mL for diameters of 0.5-1.5 cm, and 0.1 mL for diameters <0.5 cm, with a maximum of 4 mL).
Oncolytic Virus YD06-1Drug
Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10^6 pfu/mL to 10^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.

Study groups in NCT06080984
Study group	Role	What they receive
Treatment Cohort 1	Experimental	This arm includes 6 head and neck squamous cell carcinoma patients. Patients in the study receive intratumoral treatment with a novel oncolytic virus SDJ001 at two dose levels: 5x10^11 and 1x10^12 pfu per person. At the current dose levels, intratumoral injection is administered on the first day of each treatment cycle. Each treatment cycle consists of three weeks, continuing until tumor growth is observed following injection or until the patient experiences intolerable toxic effects. Ultrasound-guided injection may be used when necessary (2.0 mL for tumors with a diameter >2.5 cm, 1.0 mL for diameters of 1.5-2.5 cm, 0.5 mL for diameters of 0.5-1.5 cm, and 0.1 mL for diameters <0.5 cm, with a maximum of 4 mL). Receives: Drug: Oncolytic Virus SDJ001
Treatment Cohort 2	Experimental	This arm includes 9 melanoma patients. Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10^6 pfu/mL to 10^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals. Receives: Drug: Oncolytic Virus YD06-1
Treatment Cohort 3	Experimental	This arm includes 9 sarcoma patients. Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10^6 pfu/mL to 10^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals. Receives: Drug: Oncolytic Virus YD06-1

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events
Adverse events defined as the number of participants with adverse events
Measured: up to 12 months

Secondary outcomes (3)

Objective response rate
ORR is defined as the percentage of patients who achieve a response, which can either be complete response (complete disappearance of lesions) or partial response (reduction in the sum of maximal tumor diameters by at least 30% or more)
Measured: up to 12 months
Progress-Free Survival
PFS is defined as the time from the administration of the first dose to first disease
Measured: up to 12 months
Overall Survival
OS is defined as the time from the administration of the first dose to death.
Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 202315 Oct 2025

First posted12 Oct 2023
Study start15 Oct 2023 (estimated)
Primary completion15 Oct 2024 (estimated)
Study completion15 Oct 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Malignant TumorStudies of the same condition, open and under way.
More trials run by West China HospitalThe 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: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06080984
Sponsor's protocol ID: 2023-833
Status last verified: Oct 2023
First submitted: 6 Oct 2023
Last updated: 12 Oct 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338
Ibarra AMC, Cecatto RB, Motta LJ, Dos Santos Franco AL, de Fatima Teixeira da Silva D, Nunes FD, Hamblin MR, Rodrigues MFSD. Photodynamic therapy for squamous cell carcinoma of the head and neck: narrative review focusing on photosensitizers. Lasers Med Sci. 2022 Apr;37(3):1441-1470. doi: 10.1007/s10103-021-03462-3. Epub 2021 Dec 2.
PubMed 34855034
Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.
PubMed 26014293
Chesney JA, Ribas A, Long GV, Kirkwood JM, Dummer R, Puzanov I, Hoeller C, Gajewski TF, Gutzmer R, Rutkowski P, Demidov L, Arenberger P, Shin SJ, Ferrucci PF, Haydon A, Hyngstrom J, van Thienen JV, Haferkamp S, Guilera JM, Rapoport BL, VanderWalde A, Diede SJ, Anderson JR, Treichel S, Chan EL, Bhatta S, Gansert J, Hodi FS, Gogas H. Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma. J Clin Oncol. 2023 Jan 20;41(3):528-540. doi: 10.1200/JCO.22.00343. Epub 2022 Aug 23.
PubMed 35998300
Harrington KJ, Kong A, Mach N, Chesney JA, Fernandez BC, Rischin D, Cohen EEW, Radcliffe HS, Gumuscu B, Cheng J, Snyder W, Siu LL. Talimogene Laherparepvec and Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY-232): A Multicenter, Phase 1b Study. Clin Cancer Res. 2020 Oct 1;26(19):5153-5161. doi: 10.1158/1078-0432.CCR-20-1170. Epub 2020 Jul 15.
PubMed 32669371
Twumasi-Boateng K, Pettigrew JL, Kwok YYE, Bell JC, Nelson BH. Oncolytic viruses as engineering platforms for combination immunotherapy. Nat Rev Cancer. 2018 Jul;18(7):419-432. doi: 10.1038/s41568-018-0009-4.
PubMed 29695749
Xia ZJ, Chang JH, Zhang L, Jiang WQ, Guan ZZ, Liu JW, Zhang Y, Hu XH, Wu GH, Wang HQ, Chen ZC, Chen JC, Zhou QH, Lu JW, Fan QX, Huang JJ, Zheng X. [Phase III randomized clinical trial of intratumoral injection of E1B gene-deleted adenovirus (H101) combined with cisplatin-based chemotherapy in treating squamous cell cancer of head and neck or esophagus]. Ai Zheng. 2004 Dec;23(12):1666-70. Chinese.
PubMed 15601557
Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy. Cell. 2018 Aug 9;174(4):1031-1032. doi: 10.1016/j.cell.2018.07.035. No abstract available.
PubMed 30096300
Goradel NH, Baker AT, Arashkia A, Ebrahimi N, Ghorghanlu S, Negahdari B. Oncolytic virotherapy: Challenges and solutions. Curr Probl Cancer. 2021 Feb;45(1):100639. doi: 10.1016/j.currproblcancer.2020.100639. Epub 2020 Aug 15.
PubMed 32828575

Want to know more?

Xingchen Peng

+86 18980606753

pxx2014@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Application of Novel Oncolytic Virus in Late Stage Solid Tumors
ClinicalTrials.gov ID: NCT06080984
Acronym / sponsor ID: 2023-833
Conditions: Malignant Tumor
Keywords: Solid Tumors, Oncolytic Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 24 participants (estimated)
Lead sponsor: West China HospitalUniversity, hospital or other
Study start: 15 Oct 2023 (estimated)
Primary completion: 15 Oct 2024 (estimated)
Study completion: 15 Oct 2025 (estimated)
First posted: 12 Oct 2023 (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.

The purpose of this study is to evaluate the efficacy and safety of novel oncolytic virus in late stage solid tumors.

Detailed description

Currently, oncolytic viruses are believed to exert anti-tumor activity through three main mechanisms:

Direct Oncolytic Effect: Oncolytic viruses can undergo specific replication within tumor cells, primarily due to the tumor's specific genetic alterations that prevent the cell's signaling pathways from sensing and blocking virus replication. Tumor interferon defects prevent the regulation of the virus defense system, increasing sensitivity to virus infection. By genetic modification, the virulence factors of oncolytic viruses can be weakened or deleted, preventing virus replication in normal tissues while retaining the ability to replicate within tumor cells and kill them.
Elicitation of Anti-Tumor Immune Responses: Oncolytic virus infection of tumor cells can transform "cold" tumors into "hot" tumors, thereby triggering local and systemic anti-tumor immune responses. Immune suppressive factors in the tumor microenvironment, such as regulatory lymphocytes, interleukin-10 (IL-10), and programmed death-ligand 1 (PD-L1), can protect tumors from immune surveillance. Oncolytic viruses disrupt the existing tissue structure in the tumor microenvironment and can reverse the immunosuppressive microenvironment, transitioning it from immune suppression to immune activation. After oncolytic virus infection of tumor cells, cell lysis occurs, releasing tumor-associated antigens, activating dendritic cells, increasing the infiltration of cytotoxic T lymphocytes, and recruiting other immune-related cells and molecules. This results in an increase in tumor-specific immune responses, leading to the clearance of distant and uninfected tumor cells.
Expression of Anti-Tumor Target Genes and Anti-Angiogenesis:

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Treatment Cohort 1	Experimental	Drug: Oncolytic Virus SDJ001This arm includes 6 head and neck squamous cell carcinoma patients. Patients in the study receive intratumoral treatment with a novel oncolytic virus SDJ001 at two dose levels: 5x10^11 and 1x10^12 pfu per person. At the current dose levels, intratumoral injection is administered on the first day of each treatment cycle. Each treatment cycle consists of three weeks, continuing until tumor growth is observed following injection or until the patient experiences intolerable toxic effects. Ultrasound-guided injection may be used when necessary (2.0 mL for tumors with a diameter >2.5 cm, 1.0 mL for diameters of 1.5-2.5 cm, 0.5 mL for diameters of 0.5-1.5 cm, and 0.1 mL for diameters <0.5 cm, with a maximum of 4 mL).
Treatment Cohort 2	Experimental	Drug: Oncolytic Virus YD06-1This arm includes 9 melanoma patients. Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10^6 pfu/mL to 10^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.
Treatment Cohort 3	Experimental	Drug: Oncolytic Virus YD06-1This arm includes 9 sarcoma patients. Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10^6 pfu/mL to 10^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Male or female patients: ≥18 years.
a)Patients with confirmed advanced squamous cell carcinoma of the head and neck (including nasopharynx) who meet the following criteria: Patients who have failed standard second-line treatment. Tumors that cannot be cured through local treatment (surgery or definitive radiation therapy).
b)Patients with stage III malignant melanoma who are not eligible for surgical resection, or patients with stage IV malignant melanoma, who have failed at least two lines of standard treatment (including chemotherapy, immunotherapy or targeted therapy).
c)Patients with locally unresectable or metastatic advanced soft tissue sarcomas, who have failed prior systemic treatments.
ECOG performance status score: 0-1.

Key exclusion criteria (18 listed)

Participated in another drug clinical trial within the past 4 weeks.
Tumor located near major blood vessels or the trachea.
Has poorly controlled clinical heart symptoms or diseases, such as NYHA class 2 or higher heart failure, unstable angina, myocardial infarction within the past year, clinically significant ventricular or supraventricular arrhythmias requiring treatment or intervention.
For female subjects: pregnant or lactating women.
Persistent or active infections, including but not limited to: active pulmonary tuberculosis, positive HIV (Human Immunodeficiency Virus) antibodies, positive HBsAg (Hepatitis B Surface Antigen), positive HBcAb (Hepatitis B Core Antibody), and positive HCV (Hepatitis C Virus) antibody test results.

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 SDJ001Patients in the study receive intratumoral treatment with SDJ001 at two dose levels: 5x10^11 and 1x10^12 pfu per person. At the current dose levels, intratumoral injection is administered on the first day of each treatment cycle. Each treatment cycle consists of three weeks, continuing until tumor growth is observed following injection or until the patient experiences intolerable toxic effects. Ultrasound-guided injection may be used when necessary (2.0 mL for tumors with a diameter >2.5 cm, 1.0 mL for diameters of 1.5-2.5 cm, 0.5 mL for diameters of 0.5-1.5 cm, and 0.1 mL for diameters <0.5 cm, with a maximum of 4 mL).	Drug	Treatment Cohort 1
Oncolytic Virus YD06-1Patients in the study receive intratumoral treatment with a novel oncolytic virus YD06-1 at a concentration of 10^6 pfu/mL to 10^8 pfu/ml following a dose escalation plan. Each subject receives only one injection at the corresponding concentration, with the dose determined based on the size of the tumor mass. (Diameter ≤1.5 cm, maximum of 1 mL; diameter 1.5-2.5 cm, maximum of 2 mL; diameter greater than 2.5 cm, maximum of 4 mL). The second dose is administered three weeks after the first dose, followed by subsequent doses at two-week intervals.	Drug	Treatment Cohort 2, Treatment Cohort 3

Primary outcome

Adverse events
Time frame: up to 12 months
Adverse events defined as the number of participants with adverse events

3 secondary outcomes

Objective response rate
Time frame: up to 12 months
Progress-Free Survival
Time frame: up to 12 months
Overall Survival
Time frame: up to 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
Background: PubMed 34855034Ibarra AMC, Cecatto RB, Motta LJ, Dos Santos Franco AL, de Fatima Teixeira da Silva D, Nunes FD, Hamblin MR, Rodrigues MFSD. Photodynamic therapy for squamous cell carcinoma of the head and neck: narrative review focusing on photosensitizers. Lasers Med Sci. 2022 Apr;37(3):1441-1470. doi: 10.1007/s10103-021-03462-3. Epub 2021 Dec 2.
Background: PubMed 26014293Andtbacka RH, Kaufman HL, Collichio F, Amatruda T, Senzer N, Chesney J, Delman KA, Spitler LE, Puzanov I, Agarwala SS, Milhem M, Cranmer L, Curti B, Lewis K, Ross M, Guthrie T, Linette GP, Daniels GA, Harrington K, Middleton MR, Miller WH Jr, Zager JS, Ye Y, Yao B, Li A, Doleman S, VanderWalde A, Gansert J, Coffin RS. Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma. J Clin Oncol. 2015 Sep 1;33(25):2780-8. doi: 10.1200/JCO.2014.58.3377. Epub 2015 May 26.
Background: PubMed 35998300Chesney JA, Ribas A, Long GV, Kirkwood JM, Dummer R, Puzanov I, Hoeller C, Gajewski TF, Gutzmer R, Rutkowski P, Demidov L, Arenberger P, Shin SJ, Ferrucci PF, Haydon A, Hyngstrom J, van Thienen JV, Haferkamp S, Guilera JM, Rapoport BL, VanderWalde A, Diede SJ, Anderson JR, Treichel S, Chan EL, Bhatta S, Gansert J, Hodi FS, Gogas H. Randomized, Double-Blind, Placebo-Controlled, Global Phase III Trial of Talimogene Laherparepvec Combined With Pembrolizumab for Advanced Melanoma. J Clin Oncol. 2023 Jan 20;41(3):528-540. doi: 10.1200/JCO.22.00343. Epub 2022 Aug 23.
Background: PubMed 32669371Harrington KJ, Kong A, Mach N, Chesney JA, Fernandez BC, Rischin D, Cohen EEW, Radcliffe HS, Gumuscu B, Cheng J, Snyder W, Siu LL. Talimogene Laherparepvec and Pembrolizumab in Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (MASTERKEY-232): A Multicenter, Phase 1b Study. Clin Cancer Res. 2020 Oct 1;26(19):5153-5161. doi: 10.1158/1078-0432.CCR-20-1170. Epub 2020 Jul 15.
Background: PubMed 29695749Twumasi-Boateng K, Pettigrew JL, Kwok YYE, Bell JC, Nelson BH. Oncolytic viruses as engineering platforms for combination immunotherapy. Nat Rev Cancer. 2018 Jul;18(7):419-432. doi: 10.1038/s41568-018-0009-4.
Background: PubMed 15601557Xia ZJ, Chang JH, Zhang L, Jiang WQ, Guan ZZ, Liu JW, Zhang Y, Hu XH, Wu GH, Wang HQ, Chen ZC, Chen JC, Zhou QH, Lu JW, Fan QX, Huang JJ, Zheng X. [Phase III randomized clinical trial of intratumoral injection of E1B gene-deleted adenovirus (H101) combined with cisplatin-based chemotherapy in treating squamous cell cancer of head and neck or esophagus]. Ai Zheng. 2004 Dec;23(12):1666-70. Chinese.
Background: PubMed 30096300Ribas A, Dummer R, Puzanov I, VanderWalde A, Andtbacka RHI, Michielin O, Olszanski AJ, Malvehy J, Cebon J, Fernandez E, Kirkwood JM, Gajewski TF, Chen L, Gorski KS, Anderson AA, Diede SJ, Lassman ME, Gansert J, Hodi FS, Long GV. Oncolytic Virotherapy Promotes Intratumoral T Cell Infiltration and Improves Anti-PD-1 Immunotherapy. Cell. 2018 Aug 9;174(4):1031-1032. doi: 10.1016/j.cell.2018.07.035. No abstract available.
Background: PubMed 32828575Goradel NH, Baker AT, Arashkia A, Ebrahimi N, Ghorghanlu S, Negahdari B. Oncolytic virotherapy: Challenges and solutions. Curr Probl Cancer. 2021 Feb;45(1):100639. doi: 10.1016/j.currproblcancer.2020.100639. Epub 2020 Aug 15.
Individual participant dataSharing planned: No

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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.

Xingchen Peng contact

+86 18980606753

pxx2014@163.com

Xingchen Peng principal investigator

West China 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 SDJ001 and Oncolytic Virus YD06-1 in people with Malignant Tumor, run by West China 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 15 inclusion and 18 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 12 Oct 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 Xingchen Peng (+86 18980606753, pxx2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events (time frame: up to 12 months). 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 NCT06080984, which also lists 9 linked publications.

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 12 Oct 2023.