Advanced Malignant Solid TumorEarly Phase 1NCT06713148
Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors
A Early Phase 1 study testing IDOV-SAFETM in people with Advanced Malignant Solid Tumor, run by Fudan University.
Trial summary
This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of intratumoral Administration of IDOV-SAFETM 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
- Advanced Malignant Solid Tumor
- What is being tested?
- IDOV-SAFETM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 31 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- 18 ~75 years old, gender is not limited;
- During screening, patients with advanced malignant solid tumors confirmed by histology or cytology (mainly including breast cancer (triple-negative priority), melanoma, head and neck tumors, and gastrointestinal cancers such as colorectal cancer, cholangiocarcinoma, pancreatic cancer, and liver cancer with intratumoral injection conditions).
- At the time of screening, the disease has progressed after or during standard treatment; Or subjects with advanced malignant solid tumors who currently have no standard treatment available or are intolerant to chemotherapy.
- Tumor lesions and/or metastases with at least one evaluable lesion that is subcutaneously accessible or can be injected under imaging guidance, according to the solid tumor response criteria (RECIST version 1.1).
- When screening, the ECOG score of physical strength score is 0 or 1.
- Life expectancy assessed by the investigator at the time of screening was ≥3 months.
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- Subjects had adequate organ function at baseline:
- Bone marrow function (no growth factor support therapy or component transfusion within 14 days prior to screening) : i. Neutrophil absolute value (ANC) ≥1.5×10^9/L; ii. Hemoglobin (HB) ≥90g/L; iii. Platelet count (PLT) ≥75×10^9/L; b) Liver function: i. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times the upper limit of normal (ULN) (ALT and AST≤ 3 times ULN for liver metastasis or hepatocellular carcinoma); ii. Blood total bilirubin ≤1.5 ULN (in subjects with liver metastasis or hepatocellular carcinoma or Gilbert syndrome or familial benign nonbinding hyperbilirubinemia, the acceptable range of this indicator is ≤2.5 ULN); c) Renal function: serum creatinine ≤ 1.5x ULN or creatinine clearance ≥50mL/min; d) left ventricular ejection fraction (LVEF) ≥ 45%. e) Coagulation function: activated partial thromboplastin time (APTT) ≤1.5×ULN, International Standardized ratio (INR) ≤1.5×ULN.
- Fertile female subjects must have negative blood beta-HCG test results within 7 days prior to enrollment.
- Subjects must agree to use highly effective contraception for at least 90 days from the start of the ICF to the end of the study.
- Be fully informed of this study and voluntarily sign ICF.
Who cannot join
- At the time of screening, advanced malignant tumors have a chance of being cured by radical treatment.
- Asymptomatic brain metastases such as untreated ones at the time of screening; Subjects with symptomatic central nervous system (CNS) metastatic or cancerous meningitis; Or there was other evidence of uncontrolled central nervous system or meningeal metastases in subjects who were judged by the investigator to be unsuitable for enrollment.
- Prior to enrollment, there was severe chronic or active infection: active hepatitis B (HbsAg positive, HBV DNA test value greater than the upper limit of normal); Active hepatitis C (those with positive anti-HCV antibodies are further tested positive for HCV RNA); A known history of immunodeficiency virus (HIV) disease or a positive HIV antibody test; Other conditions requiring systemic anti-infective treatment in the 4 weeks prior to initial use of the investigational drug include, but are not limited to, hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
- At the time of screening, patients had a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or were receiving long-term systemic steroids (prednisone >10mg/ day or equivalent doses of the same drug) or any other form of immunosuppressant therapy within 4 weeks prior to the first use of the study drug.
- Patients with received allogeneic tissue or solid organ transplantation.
- There is evidence of clinically significant immunodeficiency, such as primary immunodeficiency status, such as severe combined immunodeficiency disease (SCID); Combined with opportunistic infections.
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- Anticoagulants or antiplatelet drugs should be used before injection and should not be interrupted, including: aspirin should not be stopped within 7 days before injection; Coumarin that cannot be stopped within 7 days prior to injection; Direct thrombin inhibitors (such as dabigatrun) or direct factor Xa inhibitors (such as rivaroxaban, apixaban, and neperoxaban) that cannot be discontinued within 4 days prior to injection; Low molecular weight heparin (LMWH) should not be stopped within 24 hours before injection, and ordinary heparin (UFH) should not be stopped more than 4 hours before injection.
- Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: congestive heart failure ≥II heart function grade of the New York Heart Association (NYHA); Left ventricular ejection fraction (LVEF) <50%; QT interval (QTcF) >470ms as corrected by the Fridericia method or prolonged QT interval syndrome; Acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade 3 or higher cardiovascular and cerebrovascular events occurred within 6 months before first administration; The presence of uncontrolled hypertension (systolic blood pressure >140mmHg or diastolic blood pressure >90mmHg). Subjects with a history of hypertension are admitted to the study if their blood pressure is controlled below this standard and maintained with antihypertensive therapy.
- Patients with received treatment with other methods, including but not limited to chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy, etc., within 4 weeks prior to the first use of the investigational drug.
- Other diseases or abnormalities assessed by the investigator as unsuitable for participation in the study.
- Vaccination against smallpox or monkeypox within 10 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I Clinical Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors
This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of intratumoral Administration of IDOV-SAFETM in patients with advanced solid tumors.
Read the detailed description
The therapeutic dose for mice was 1x10^8 PFU, and the maximum starting dose for humans was 2.67x10^9 PFU based on the Guidelines for Estimating the Maximum Recommended Starting Dose for the First Clinical Trial of Healthy Adult Volunteers.
Dose escalation phase:
At this stage, the investigators plan to enroll about 13-25 patients with advanced malignant solid tumors confirmed by histology or cytology after failure of standard treatment or without standard treatment in China for intratumoral injection of IDOV-SAFETM.
This phase consisted of five dose groups: 1x10^8 PFU, 3x10^8 PFU, 7x10^8 PFU, 1x10^9 PFU and 3x10^9 PFU. The first dose group included 1 subject, and the other dose groups were increased by "3+3", with 3-6 subjects in each group. Each patient received intratumoral injection on the first day, 14 days as a course of treatment. The follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive assessment of the subjects' conditions; All subjects in each dose group may be incremented to the next dose group after completing a safety assessment 21 days after the first dose.
The dose escalation or setting may be adjusted as determined by the Safety Committee (SMC).
Dose expansion phase:
According to the results of the phase I trial, one dose was selected for dose expansion, and the selected dose level was extended to 5~18 patients. Each patient received intratumoral injection on the first day, and 14 days was a course of treatment. The subsequent investigators decided whether to continue the administration of the second (D14) and third (D28) courses according to the comprehensive evaluation of the subjects' conditions. Each patient was treated for at least one course of treatment (14 days).
Based on the preliminary clinical trial data, the number of injections and the interval time of administration can be adjusted during the dose expansion phase after the decision of the Safety Committee (SMC).
Duration of administration:
In both phases, safety and efficacy were evaluated 42 days after initial dosing. If CT evaluation suspects false progression, puncture and pathology examination are required.
After SMC's decision, it is determined that the benefits of continued treatment outweigh the risks of the subject, and if the subject wishes to continue treatment, the subject may continue to receive the experimental drug. The specific course of treatment will be determined by the SMC based on preliminary clinical trial data.
The safety and efficacy of the investigational drug will be evaluated periodically during continued dosing, and the risk and benefit of continuing treatment will be determined by the SMC. If benefit > risk is no longer satisfied, the long-term safety and survival follow-up period is entered.
Long-term safety and survival follow-up:
Adverse events occurring throughout the study from the first dosing of each subject in both phases will be collected, and long-term safety and survival follow-up will continue up to 2 years after the last dosing (site visits every 8 weeks from the DLT observation period until patients meet end-of-treatment criteria or the end of survival follow-up date, whichever arrives first).
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- IDOV-SAFETM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDOV-SAFETMBiological
Each patient received intratumoral injection on the first day, 14 days as a course of treatment, and the follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive evaluation of the subjects' conditions
| Study group | Role | What they receive |
|---|---|---|
| Oncolytic Virus injection(IDOV-SAFETM) | Experimental | Intratumoral administration of IDOV-SAFETM every 2 weeks for patients with advanced solid tumors.
Dose cohorts: 1x10^8 PFU、3x10^8 PFU、7x10^8 PFU 、1x10^9 PFU and 3x10^9 PFU Receives: Biological: IDOV-SAFETM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities (DLT)
Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions
Measured: up to 3 weeks
Incidence of adverse events (AE)
Incidence of adverse events (AE)
Measured: through study completion, an average of 2 years
Secondary outcomes (10)
Levels of viral DNA in blood
Peripheral blood was collected for viral DNA and live viral load measurement
Measured: up to 3days
T cell subsets
Analysis 1: Reactivation of memory T cells; Analysis 2: Multifunctional recovery of exhausted T cells.
Measured: through study completion, an average of 1 year
Tumor infiltrates lymphocytes
Tumor tissue samples were immunohistochemically stained with anti-CD8 antibodies, and then tumor infiltrating lymphocytes were analyzed.
Measured: through study completion, an average of 1 year
TCR spectrum analysis
Blood and tumor tissue samples were used for TCR analysis. For tumor tissue samples, samples taken by biopsy during this clinical trial were used.
Measured: through study completion, an average of 1 year
The level of (non-essential) viral DNA in tumor tissue
At least one patient in each dose group was biopsied, 7 days after dosing, and pathological slides were compared with baseline.
Measured: through study completion, an average of 1 year
Objective response rate
The sum of the proportion of subjects with Complete response or Partial response
Measured: through study completion, an average of 1 year
Disease control rate
The sum of the proportion of subjects with Complete response 、Partial response or Stable disease
Measured: through study completion, an average of 1 year
During of response
The time between the start of the first assessment of the tumor as Complete response or Partial response and the second assessment as PD(Progressive Disease) or death from any cause
Measured: through study completion, an average of 1 year
Progression Free Survival
The time, measured in days, from the date of first treatment to disease progression or death from any cause. Disease progression and death were measured in terms of preoccurrence. Progression included radiographic progression or clinical progression as assessed by the investigator.
Measured: through study completion, an average of 1 year
Overall Survival
The time from the date of first treatment to death from any cause, measured in days
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Apr 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongxia Wang, Fudan University
- Investigators
- Hongxia Wang, PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713148
- Sponsor's protocol ID
- LY001-F002
- Status last verified
- Dec 2024
- First submitted
- 11 Sep 2024
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study on the Safety and Efficacy of Intratumoral Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06713148
- Acronym / sponsor ID
- LY001-F002
- Conditions
- Advanced Malignant Solid Tumor
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Dec 2024 (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, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of intratumoral Administration of IDOV-SAFETM in patients with advanced solid tumors.
Detailed description
The therapeutic dose for mice was 1x10^8 PFU, and the maximum starting dose for humans was 2.67x10^9 PFU based on the Guidelines for Estimating the Maximum Recommended Starting Dose for the First Clinical Trial of Healthy Adult Volunteers.
Dose escalation phase:
At this stage, the investigators plan to enroll about 13-25 patients with advanced malignant solid tumors confirmed by histology or cytology after failure of standard treatment or without standard treatment in China for intratumoral injection of IDOV-SAFETM.
This phase consisted of five dose groups: 1x10^8 PFU, 3x10^8 PFU, 7x10^8 PFU, 1x10^9 PFU and 3x10^9 PFU. The first dose group included 1 subject, and the other dose groups were increased by "3+3", with 3-6 subjects in each group. Each patient received intratumoral injection on the first day, 14 days as a course of treatment. The follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive assessment of the subjects' conditions; All subjects in each dose group may be incremented to the next dose group after completing a safety assessment 21 days after the first dose.
The dose escalation or setting may be adjusted as determined by the Safety Committee (SMC).
Dose expansion phase:
According to the results of the phase I trial, one dose was selected for dose expansion, and the selected dose level was extended to 5~18 patients. Each patient received intratumoral injection on the first day, and 14 days was a course of treatment. The subsequent investigators decided whether to continue the administration of the second (D14) and third (D28) courses according to the comprehensive evaluation of the subjects' conditions. Each patient was treated for at least one course of treatment (14 days).
Based on the preliminary clinical trial data, the number of injections and the interval time of administration can be adjusted during the dose expansion phase after the decision of the Safety Committee (SMC).
Duration of administration:
In both phases, safety and efficacy were evaluated 42 days after initial dosing. If CT evaluation suspects false progression, puncture and pathology examination are required.
After SMC's decision, it is determined that the benefits of continued treatment outweigh the risks of the subject, and if the subject wishes to continue treatment, the subject may continue to receive the experimental drug. The specific course of treatment will be determined by the SMC based on preliminary clinical trial data.
The safety and efficacy of the investigational drug will be evaluated periodically during continued dosing, and the risk and benefit of continuing treatment will be determined by the SMC. If benefit > risk is no longer satisfied, the long-term safety and survival follow-up period is entered.
Long-term safety and survival follow-up:
Adverse events occurring throughout the study from the first dosing of each subject in both phases will be collected, and long-term safety and survival follow-up will continue up to 2 years after the last dosing (site visits every 8 weeks from the DLT observation period until patients meet end-of-treatment criteria or the end of survival follow-up date, whichever arrives first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncolytic Virus injection(IDOV-SAFETM) | Experimental | Biological: IDOV-SAFETMIntratumoral administration of IDOV-SAFETM every 2 weeks for patients with advanced solid tumors. Dose cohorts: 1x10^8 PFU、3x10^8 PFU、7x10^8 PFU 、1x10^9 PFU and 3x10^9 PFU |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18 ~75 years old, gender is not limited;
- During screening, patients with advanced malignant solid tumors confirmed by histology or cytology (mainly including breast cancer (triple-negative priority), melanoma, head and neck tumors, and gastrointestinal cancers such as colorectal cancer, cholangiocarcinoma, pancreatic cancer, and liver cancer with intratumoral injection conditions).
- At the time of screening, the disease has progressed after or during standard treatment; Or subjects with advanced malignant solid tumors who currently have no standard treatment available or are intolerant to chemotherapy.
- Tumor lesions and/or metastases with at least one evaluable lesion that is subcutaneously accessible or can be injected under imaging guidance, according to the solid tumor response criteria (RECIST version 1.1).
- When screening, the ECOG score of physical strength score is 0 or 1.
Key exclusion criteria (11 listed)
- At the time of screening, advanced malignant tumors have a chance of being cured by radical treatment.
- Asymptomatic brain metastases such as untreated ones at the time of screening; Subjects with symptomatic central nervous system (CNS) metastatic or cancerous meningitis; Or there was other evidence of uncontrolled central nervous system or meningeal metastases in subjects who were judged by the investigator to be unsuitable for enrollment.
- Prior to enrollment, there was severe chronic or active infection: active hepatitis B (HbsAg positive, HBV DNA test value greater than the upper limit of normal); Active hepatitis C (those with positive anti-HCV antibodies are further tested positive for HCV RNA); A known history of immunodeficiency virus (HIV) disease or a positive HIV antibody test; Other conditions requiring systemic anti-infective treatment in the 4 weeks prior to initial use of the investigational drug include, but are not limited to, hospitalization for infectious complications, bacteremia, severe pneumonia, or active tuberculosis.
- At the time of screening, patients had a history of active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc., or were receiving long-term systemic steroids (prednisone >10mg/ day or equivalent doses of the same drug) or any other form of immunosuppressant therapy within 4 weeks prior to the first use of the study drug.
- Patients with received allogeneic tissue or solid 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 |
|---|---|---|
| IDOV-SAFETMEach patient received intratumoral injection on the first day, 14 days as a course of treatment, and the follow-up investigator decided whether to continue the second (D14) and third (D28) course of administration according to the comprehensive evaluation of the subjects' conditions | Biological | Oncolytic Virus injection(IDOV-SAFETM) |
Primary outcome
Dose Limiting Toxicities (DLT)
Time frame: up to 3 weeks
Dose-limiting toxicity is defined as an adverse event that is considered to be drug-related and meets one of the Protocol definitions
Incidence of adverse events (AE)
Time frame: through study completion, an average of 2 years
Incidence of adverse events (AE)
10 secondary outcomes
Levels of viral DNA in blood
Time frame: up to 3days
T cell subsets
Time frame: through study completion, an average of 1 year
Tumor infiltrates lymphocytes
Time frame: through study completion, an average of 1 year
TCR spectrum analysis
Time frame: through study completion, an average of 1 year
The level of (non-essential) viral DNA in tumor tissue
Time frame: through study completion, an average of 1 year
Objective response rate
Time frame: through study completion, an average of 1 year
Disease control rate
Time frame: through study completion, an average of 1 year
During of response
Time frame: through study completion, an average of 1 year
Progression Free Survival
Time frame: through study completion, an average of 1 year
Overall Survival
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- 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.
Hongxia Wang, PhD principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IDOV-SAFETM in people with Advanced Malignant Solid Tumor, run by Fudan University.
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 11 inclusion and 11 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: opening soon, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Chen, PhD (17321168230, jianhuachen15@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 3 weeks). 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 6 Feb 2025.