Head and Neck CancerEarly Phase 1NCT05830240
A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Relapsed/Refractory Head and Neck Cancer
A Early Phase 1 study testing Recombinant oncolytic herpes simplex virus type 1 (R130) in people with Head and Neck Cancer and Esophageal Cancer, run by Shanghai Yunying Medical Technology at 1 site in China.
Trial summary
9 participants are expected to be enrolled for this open，single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Esophageal Cancer, Otorhinolaryngologic Neoplasms
- What is being tested?
- Recombinant oncolytic herpes simplex virus type 1 (R130)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2023to 27 Mar 2026
- Phase
- Early 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.
- Age 18 to 75 years.
- No absolute or relative centasis contraindiction，have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.
- No severe functinonal falure of heart, brain, liver, kidney and lung.
- Subjects with ECOG score of 0-2, and expected survival of 3 months or more.
- No evidence of clinically significant immunosuppression.
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- Patients must have the following hematologic parameters, Coagulation functions and hepatic and renal function during the screening period:
- White Blood Cell (WBC)≥3.0×10^9/L；
- Absolute Lymphocyte Count (ANC)≥1.5×10^9/L;
- Platelet≥100×10^9/L；
- Prothrombin time (PT) or activated Partial Thromboplastin Time（APTT）≤1.5×ULN;
- Serum Creatinine (Scr)≤1.5×ULN
- Alanine aminotransferase(AST/ALT) ≤3×ULN;
- Total Bilirubin(TBIL)≤1.5×ULN.
- Be able to understand and sign the informed consent document;
- Be able to stick to follow-up visit plan and other requirements in the agreement.
Who cannot join
- With a history of allergy to similar drugs.
- With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors.
- pregnancy, breast feeding.
- Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
- Impaired function of important organs or a history of organ transplantation.
- Receiving antiherpes simplex virus therapy such as acyclovir, ganciclovir, vancomycin, and acepromazine within 4 weeks.
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- Have had antitumor therapy, including endocrine, chemotherapy, radiotherapy, targeted therapy, immunotherapy and antitumor herbal therapy,4 weeks prior to the first dose.
- Have had any serious adverse reactions associated with immunotherapy and have not recovered to CTCAE 5.0 grade rating 0 or 1 level of toxicity after previous antineoplastic therapy.
- Subjects with any severe and/or uncontrolled disease, including: a) poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg); b) suffering from class I or higher myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥ 470 ms and ≥ grade 2 congestive heart failure (New York Heart Association (NYHA) classification); c) active or uncontrolled severe infection (≥ CTCAE grade 2 infection); d) Patients with previous organ transplantation, bone marrow transplantation (hematopoietic stem cell transplantation) and severe immune deficiency; e) Urine routine suggesting urine protein ≥++ and confirmed 24-hour urine protein quantification > 1.0 g.
- Patients with past history of type I diabetes mellitus.
- Severe abnormalities in thyroid and cortisol testing; active, known or suspected autoimmune disease requiring systemic therapy.
- Patients with active bleeding or severe coagulation dysfunction.
- Researchers considering the test subject as having a history of other severe systemic diseases, or other reasons inappropriate for the clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye & ENT Hospital of Fudan University
Shanghai, 200000
Haitao Wu, Ph.D, +86 18917785578, eentwuhaitao@163.com
Jian Chen, +86 18917785406, chenjent@qq.com
About this study
Official title: A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Head and Neck Cancer
9 participants are expected to be enrolled for this open，single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.
- Conditions
- Head and Neck Cancer, Esophageal Cancer, Otorhinolaryngologic Neoplasms, Ear Cancer, Nose Cancer, Laryngeal Cancer
- Being tested
- Recombinant oncolytic herpes simplex virus type 1 (R130)
- Keywords
- Oncolytic virus, Herpes simplex virus type 1
- Medical subject headings
- Head and Neck Neoplasms, Esophageal Neoplasms, Otorhinolaryngologic Neoplasms, Ear Neoplasms, Nose Neoplasms, Laryngeal Neoplasms, Pharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant oncolytic herpes simplex virus type 1 (R130)Drug
Also called Oncolytic virus
R130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11
| Study group | Role | What they receive |
|---|---|---|
| R130 Treatment Group | Experimental | Every 7-14 days,1-2 ml R130 （concentration of 1x10^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral in patients with relapsed/refractory head and neck cancer Receives: Drug: Recombinant oncolytic herpes simplex virus type 1 (R130) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Profile Measured by Grade ≥3 CTCAE v5.0
To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
Measured: Up to 6 months
Systemic immune response
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa，IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
Measured: Up to 6 months
Secondary outcomes (3)
Disease Assessment for Disease Control Rate
Evaluate the efficacy endpoints of DCR by the investigator with RECIST v1.1 and iRECIST
Measured: Every 10 weeks for 12 months
Disease Assessment for Duration of Response
Evaluate the efficacy endpoints of DOR by the investigator with RECIST v1.1 and iRECIST
Measured: Every 10 weeks for 12 months
Quality of Life Assessment
Evaluate with EORTC QLQ-C30
Measured: Every 6 weeks for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start27 Mar 2023
- Primary completion27 Mar 2025 (estimated)
- Study completion27 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yunying Medical Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eye & ENT Hospital of Fudan University
- Responsible party
- Sponsor
- Investigators
- Haitao Wu, Phd, Principal investigator, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830240
- Sponsor's protocol ID
- SHWG-R130-HNC
- Status last verified
- Apr 2023
- First submitted
- 31 Mar 2023
- Last updated
- 26 Apr 2023
- 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 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Safety and Efficacy Study on Oncolytic Virus Injection (R130) for the Treatment of Relapsed/Refractory Head and Neck Cancer
- ClinicalTrials.gov ID
- NCT05830240
- Acronym / sponsor ID
- SHWG-R130-HNC
- Conditions
- Head and Neck Cancer, Esophageal Cancer, Otorhinolaryngologic Neoplasms, Ear Cancer, Nose Cancer, Laryngeal Cancer
- Keywords
- Oncolytic virus, Herpes simplex virus type 1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Shanghai Yunying Medical TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Eye & ENT Hospital of Fudan University
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 27 Mar 2025 (estimated)
- Study completion
- 27 Mar 2026 (estimated)
- First posted
- 26 Apr 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.
9 participants are expected to be enrolled for this open，single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with relapsed/refractory head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R130 Treatment Group | Experimental | Drug: Recombinant oncolytic herpes simplex virus type 1 (R130)Every 7-14 days,1-2 ml R130 （concentration of 1x10^8 plaque-forming Units/mL,PFU/mL）will be injected intratumoral in patients with relapsed/refractory head and neck cancer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients with head and neck cancer clearly diagnosed by histology and/or cytology, without systematic metastasis, and failure of standard treatment.
- Age 18 to 75 years.
- No absolute or relative centasis contraindiction，have at least one measurable lesion (according to RECIST 1.1 criteria) that is amenable to intratumoral drug delivery.
- No severe functinonal falure of heart, brain, liver, kidney and lung.
- Subjects with ECOG score of 0-2, and expected survival of 3 months or more.
Key exclusion criteria (13 listed)
- With a history of allergy to similar drugs.
- With hematological diseases, malignant tumors of the central nervous system, or combined with other malignant tumors.
- pregnancy, breast feeding.
- Current active hepatitis B, active hepatitis C, immunodeficiency virus or other active infection of clinical significance.
- Impaired function of important organs or a history of organ transplantation.
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 |
|---|---|---|
| Recombinant oncolytic herpes simplex virus type 1 (R130)Also: Oncolytic virusR130, a modified herpes simplex virus-Ⅰ (HSV-1) containing the gene coding for anti-CD3 scFv/CD86/PD1/HSV2-US11 | Drug | R130 Treatment Group |
Primary outcome
Safety Profile Measured by Grade ≥3 CTCAE v5.0
Time frame: Up to 6 months
To characterize the safety profile of R130 injection in patients with relapsed/refractory head and neck cancer as measured by the incidence of Grade ≥ 3 Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v5.0)
Systemic immune response
Time frame: Up to 6 months
Detection of increased systemic immune Response markers in sera (IL2,IL4,IL6,IL8,IL10,TNFa，IFNγ, etc.) and peripheral blood mononuclear cells by multi-Color fluorescence-activated cell sorting (FACS)
3 secondary outcomes
Disease Assessment for Disease Control Rate
Time frame: Every 10 weeks for 12 months
Disease Assessment for Duration of Response
Time frame: Every 10 weeks for 12 months
Quality of Life Assessment
Time frame: Every 6 weeks for 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- 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.
Haitao Wu, Phd principal investigator
Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Recombinant oncolytic herpes simplex virus type 1 (R130) in people with Head and Neck Cancer and Esophageal Cancer, run by Shanghai Yunying Medical Technology 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 16 inclusion and 13 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 26 Apr 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Feng Pan, MD (+86 13764868528, pf@jxyymedtech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Profile Measured by Grade ≥3 CTCAE v5.0 (time frame: Up to 6 months). 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 26 Apr 2023.