Head and Neck CancerEarly Phase 1YSCH-01NCT05180851
Safety and Efficacy of Recombinant Oncolytic Adenovirus L-IFN Injection in Relapsed/Refractory Solid Tumors Clinical Study
A Early Phase 1 study testing Recombinant L-IFN adenovirus injection in people with Head and Neck Cancer and Melanoma, run by Shanghai Fengxian District Central Hospital at 1 site in China.
Trial summary
This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-01） when administered via intratumoral injection in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Head and Neck Cancer, Melanoma, Breast Cancer
- What is being tested?
- Recombinant L-IFN adenovirus injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2021to 31 Dec 2023
- 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
- Male or female aged ≥ 18 and ≤ 75 years;
- Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who have failed standard therapy, have no standard therapy, are not eligible for standard therapy at this stage, or have refused standard therapy；
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to CT or MRI cross-sectional images;CT scan of the longest axis of measurable lesions ≥10 mm (CT scan thickness ≤5 mm)；
- There were injectable tumor lesions that met the requirements of the current dose group, including superficial lesions and deep lesions that could be injected under the guidance of B-ultrasound /CT；
- ECOG score of 0 ~ 2;
- Sufficient hematopoietic capacity: ANC ≥1.0 ×10^9/L (no short-acting albino within 1 week, no long-acting albino within 2 weeks), platelet count ≥75 ×10^9/L, HGB > 80 g/L (no blood transfusion within 2 weeks)；
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- Adequate liver and kidney function: AST and ALT ≤3 times ULN in patients without liver metastasis, ≤5 times ULN in patients with liver metastasis; Total bilirubin ≤1.5 ULN (excluding hyperbilirubinemia or hyperbilirubin of non-liver origin);Creatinine ≤2.0 ULN and creatinine clearance and creatinine clearance ≥40 mL/min;
- Eligible and fertile patients (male and female) must agree to use a reliable contraceptive method during the trial and for at least 90 days after the last dose; Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days before starting treatment;
- PT or INR <1.5 ULN, and APTT <1.5 ULN；
- Expect to live at least 12 weeks；
Who cannot join
- Received any antineoplastic therapy within 2 weeks prior to initial treatment；
- Systemic diseases that have not been stably controlled after treatment, such as diabetes, serious organic cardiovascular and cerebrovascular diseases, cardiac insufficiency, hypertension, heart block above ⅱ degree, myocardial infarction within 6 months, cerebral infarction within 6 months, etc.
- Pregnancy or lactation;
- Uncontrolled infectious diseases, such as baseline HBV DNA≥2000 IU/ml, anti-HIV positive, HCV-RNA positive;
- Other active infections of significant clinical significance;
- Subjects with other active malignancies within the past 5 years, such as basal or squamous skin cancer, superficial bladder cancer, or breast cancer in situ, that have been completely cured and do not require follow-up treatment are excluded;
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- Severe autoimmune diseases such as ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, or Wegener's granuloma require long-term (more than 2 months) systemic immunosuppressive therapy, but subjects with the following conditions are admitted:
- Autoimmune hypothyroidism requiring only hormone replacement therapy; Skin disorders that do not require systemic treatment (e.g., eczema, a rash of less than 10% of the body surface);
- Subjects with allergic constitution, allergy to immunotherapy or related drugs;
- Organ failure; Coronary heart: grades ⅲ and ⅳ;Or hypertension that cannot be controlled by standard treatment, a history of myocarditis or myocardial infarction within one year; Gallo liver: achieves grade C on the Child-Turcotte-Pugh liver function scale; Gallonic kidney: renal failure and uremia; Lung: symptoms of severe respiratory failure; Brain unconsciously: people with consciousness disorder have active brain metastases;
- Patients with active bleeding and thrombotic diseases requiring treatment;
- Patients with uncontrollable pleural and abdominal effusion requiring clinical treatment or intervention;
- Subjects requiring systemic corticosteroids (equivalent to >10 mg prednisone/day) within 14 days prior to enrollment or during the study period;
- The following conditions are allowed to join the group:
- Allow subjects to use topical or inhaled corticosteroids; Allows short-term (≤7 days) use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases;
- Subject suffering from any mental illness, including dementia, altered mental state, that may affect informed consent and understanding of the relevant questionnaire;
- Participated in clinical trials of other drugs or medical devices within 4 weeks;
- If the investigator determines that they have a serious and uncontrollable disease or other conditions that may affect their acceptance of this study, they are not considered suitable for this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Fengxian District Central Hospital
Shanghai, Shanghai Municipality, 201406
About this study
Official title: Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study
This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-01） when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection
Read the detailed description
This is an investigator initiated , open-label, study of Recombinant oncolytic adenovirus L-IFN injection given via intratumoral (IT) injection as a single agent in participants with advanced solid tumors. The study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of Recombinant L-IFN adenovirus injection. Total enrollment will depend on the toxicities and/or activity observed, with approximately19-28 evaluable participants enrolled.
The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of Recombinant oncolytic adenovirus L-IFN injection as a single agent. Secondary objectives will assess efficacy overall response rate, as well as disease control rate, progression free survival, duration of response, and anti-tumor immune responses.
- Conditions
- Head and Neck Cancer, Melanoma, Breast Cancer, Bladder Cancer, Ovarian Carcinoma, Cervical Carcinoma
- Being tested
- Recombinant L-IFN adenovirus injection
- Keywords
- Cancer targetting gene-virotherapy(CTGVT) virus (YSCH-01), Oncolytic virus, Oncolytic adenovirus, Replicative adenovirus
- Medical subject headings
- Head and Neck Neoplasms, Melanoma, Breast Neoplasms, Urinary Bladder Neoplasms, Ovarian Neoplasms, Uterine Cervical Neoplasms, Lung Neoplasms, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant L-IFN adenovirus injectionDrug
Also called (YSCH-01), Cancer targetting gene-virotherapy(CTGVT) virus (YSCH-01), Replicative adenovirus, Oncolytic virus
Before use, dilute the product with normal saline according to the size of the tumor to an appropriate volume (10-30% of the total volume of the tumor), or adjust appropriately according to the specific tumor situation, inject directly into the tumor or inject under the guidance of B ultrasound /CT, inject the drug solution into the tumor edge and tumor evenly
| Study group | Role | What they receive |
|---|---|---|
| Safety and efficacy of recombinant L-IFN adenovirus injection in relapsed/refractory solid tumors | Experimental | 1.Only 1 lesion: If the tumor volume is less than or equal to 10 cm3, the whole tumor is injected radially and evenly.
If the tumor volume was >10 cm3, the tumor was evenly divided into five quadrants and injected into one quadrant at a time.
2. If there are 2 or more lesions, the most manageable tumor injection is selected; 3. Priority should be given to the body surface metastases that meet the evaluation criteria for tumor efficacy.
4. According to patients' conditions (e.g., patients with thorax and ascites), the investigator and the research group and cooperative units jointly explored other drug administration approaches (e.g., bladder infusion, thorax and abdominal cavity administration) Receives: Drug: Recombinant L-IFN adenovirus injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors.
Measured: Up to 28 days
Safety and tolerability assessed by Adverse Events (AEs)
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP
Measured: Time Frame: Up to 6 months
Secondary outcomes (3)
Number of participants with vital sign abnormalities and /or adverse event
Number of participants with potentially clinically significant laboratory values
Measured: Up to 6 months
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with potentially clinically significant laboratory values
Measured: Up to 6 months
Presence of neutralizing antibodies of antidrug antibodies (ADAs) development
To evaluate the immunogenicity of Recombinant L-IFN adenovirus injection given as single agent post injection
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start30 Nov 2021
- Primary completion30 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Fengxian District Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yuansong Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Rong Zhang, MD, Principal investigator, Shanghai Fengxian District Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180851
- Sponsor's protocol ID
- YSCH-01-0000
- Acronym
- YSCH-01
- Status last verified
- Jan 2022
- First submitted
- 20 Dec 2021
- Last updated
- 1 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
He Y, Huang X, Li X, Liu H, Liu M, Tao J, Shan Y, Raza HK, Liu Y, Zhong W, Cao XP, Yang YY, Li R, Fang XL, Zhang KJ, Zhang R, Liu F. Preliminary efficacy and safety of YSCH-01 in patients with advanced solid tumors: an investigator-initiated trial. J Immunother Cancer. 2024 May 7;12(5):e008999. doi: 10.1136/jitc-2024-008999.
PubMed 38719544
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Recombinant L-IFN Adenovirus Injection in Relapsed/Refractory Solid Tumors: a Single/Multicenter, Dose-increasing, Cohort Extension Clinical Study
- ClinicalTrials.gov ID
- NCT05180851
- Acronym / sponsor ID
- YSCH-01 / YSCH-01-0000
- Conditions
- Head and Neck Cancer, Melanoma, Breast Cancer, Bladder Cancer, Ovarian Carcinoma, Cervical Carcinoma
- Keywords
- Cancer targetting gene-virotherapy(CTGVT) virus (YSCH-01), Oncolytic virus, Oncolytic adenovirus, Replicative adenovirus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Shanghai Fengxian District Central HospitalUniversity, hospital or other
- Collaborators
- Shanghai Yuansong Biotechnology Co., Ltd.
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, dose escalation study of the safety and tolerability of Recombinant oncolytic adenovirus L-IFN injection（YSCH-01） when administered via intratumoral injection in patients with advanced solid tumors. The purpose of this study is to assess the safety and tolerability of Recombinant L-IFN adenovirus injectionand to determine the recommended phase 1 dose for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of Recombinant L-IFN adenovirus injection
Detailed description
This is an investigator initiated , open-label, study of Recombinant oncolytic adenovirus L-IFN injection given via intratumoral (IT) injection as a single agent in participants with advanced solid tumors. The study is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of Recombinant L-IFN adenovirus injection. Total enrollment will depend on the toxicities and/or activity observed, with approximately19-28 evaluable participants enrolled.
The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of Recombinant oncolytic adenovirus L-IFN injection as a single agent. Secondary objectives will assess efficacy overall response rate, as well as disease control rate, progression free survival, duration of response, and anti-tumor immune responses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Safety and efficacy of recombinant L-IFN adenovirus injection in relapsed/refractory solid tumors | Experimental | Drug: Recombinant L-IFN adenovirus injection1.Only 1 lesion: If the tumor volume is less than or equal to 10 cm3, the whole tumor is injected radially and evenly. If the tumor volume was >10 cm3, the tumor was evenly divided into five quadrants and injected into one quadrant at a time. 2. If there are 2 or more lesions, the most manageable tumor injection is selected; 3. Priority should be given to the body surface metastases that meet the evaluation criteria for tumor efficacy. 4. According to patients' conditions (e.g., patients with thorax and ascites), the investigator and the research group and cooperative units jointly explored other drug administration approaches (e.g., bladder infusion, thorax and abdominal cavity administration) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female aged ≥ 18 and ≤ 75 years;
- Patients with advanced malignant solid tumors, histologically or cytologically confirmed, who have failed standard therapy, have no standard therapy, are not eligible for standard therapy at this stage, or have refused standard therapy；
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1), the length of non-lymph node lesion ≥10 mm or the short diameter of lymph node lesion ≥15 mm according to CT or MRI cross-sectional images;CT scan of the longest axis of measurable lesions ≥10 mm (CT scan thickness ≤5 mm)；
- There were injectable tumor lesions that met the requirements of the current dose group, including superficial lesions and deep lesions that could be injected under the guidance of B-ultrasound /CT；
- ECOG score of 0 ~ 2;
Key exclusion criteria (18 listed)
- Received any antineoplastic therapy within 2 weeks prior to initial treatment；
- Systemic diseases that have not been stably controlled after treatment, such as diabetes, serious organic cardiovascular and cerebrovascular diseases, cardiac insufficiency, hypertension, heart block above ⅱ degree, myocardial infarction within 6 months, cerebral infarction within 6 months, etc.
- Pregnancy or lactation;
- Uncontrolled infectious diseases, such as baseline HBV DNA≥2000 IU/ml, anti-HIV positive, HCV-RNA positive;
- Other active infections of significant clinical significance;
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 L-IFN adenovirus injectionAlso: (YSCH-01), Cancer targetting gene-virotherapy(CTGVT) virus (YSCH-01), Replicative adenovirus, Oncolytic virusBefore use, dilute the product with normal saline according to the size of the tumor to an appropriate volume (10-30% of the total volume of the tumor), or adjust appropriately according to the specific tumor situation, inject directly into the tumor or inject under the guidance of B ultrasound /CT, inject the drug solution into the tumor edge and tumor evenly | Drug | Safety and efficacy of recombinant L-IFN adenovirus injection in relapsed/refractory solid tumors |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: Up to 28 days
To define the maximum tolerated dose (MTD) of intratumoral administration of Recombinant L-IFN adenovirus injection in humans with malignant tumors.
Safety and tolerability assessed by Adverse Events (AEs)
Time frame: Time Frame: Up to 6 months
An AE is any untoward medical occurrence in a subject administered an investigational product (IP), and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of IP whether or not considered related to the IP
3 secondary outcomes
Number of participants with vital sign abnormalities and /or adverse event
Time frame: Up to 6 months
Number of participants with laboratory value abnormalities and/or adverse events
Time frame: Up to 6 months
Presence of neutralizing antibodies of antidrug antibodies (ADAs) development
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
- Derived from this study: PubMed 38719544He Y, Huang X, Li X, Liu H, Liu M, Tao J, Shan Y, Raza HK, Liu Y, Zhong W, Cao XP, Yang YY, Li R, Fang XL, Zhang KJ, Zhang R, Liu F. Preliminary efficacy and safety of YSCH-01 in patients with advanced solid tumors: an investigator-initiated trial. J Immunother Cancer. 2024 May 7;12(5):e008999. doi: 10.1136/jitc-2024-008999.
- Individual participant dataSharing planned: Undecided
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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.
Rong Zhang, MD principal investigator
Shanghai Fengxian District Central Hospital
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 L-IFN adenovirus injection in people with Head and Neck Cancer and Melanoma, run by Shanghai Fengxian District Central 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 10 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 1 Feb 2022. 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 Rong Zhang, MD (86-13818868345, rongzhang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicities (DLT) (time frame: Up to 28 days). 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?
On the ClinicalTrials.gov record for NCT05180851, which also lists 1 linked publication.
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 1 Feb 2022.