Hepatocellular CarcinomaPhase 1NCT04612504
SynOV1.1 Intratumoral Injection Study
A Phase 1 study testing SynOV1.1 in people with Hepatocellular Carcinoma, run by Beijing Syngentech Co., Ltd. at 1 site in China.
Trial summary
This is a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- SynOV1.1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2022to 30 Jun 2024
- 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
- Voluntarily participates in the clinical trial study; fully understands the study and signs the ICF; and is willing to follow and will be able to complete all trial procedures.
- Is ≥18 years old when signing ICF; male or female.
- Has locally advanced or metastatic AFP-positive solid tumorsthat has relapsed or is refractory to standard cancer therapies, or where no standard therapies are available. AFP positive means that serum samples have levels of AFP> 20 ng/ml during screening or an AFP immunohistochemistry [IHC] test of previous tumor tissue samples was positive.
- Has at least one lesion that cannot be surgically removed which can be injected directly or through ultrasound (US) and/or computer tomography (CT) guidance.
- Has at least one measurable tumor lesion.
- Has a Child-Pugh score of Class A.
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- Has an ECOG performance status is 0 to 1 one week prior to the treatment.
- Has an expected survival time of ≥ 12 weeks.
- Has limited alterations in hematology or clinical chemistry: ANC≥ 1.5 × 10^9/L, PLT≥ 75 × 109/L, TBIL≤ 1.5 ×ULN, AST and ALT≤5 × ULN, Alb≥ 2.8 g/dL, Crea≤ 1.5 × ULN, INR≤ 1.5 × ULN.
- Agrees to provide archived or fresh tumor tissue specimens according to the individual's situation and blood samples.
- A female participant who is postmenopausal, or whose serum pregnancy test result is negative. A woman who has not experienced a menstrual period for 12 months due to non-medical reasons is considered postmenopausal.
- Female participants of child-bearing potential and male participants shall agree to take medically acceptable contraception measures (hormones, barrier, or abstinence) while on treatment and for 90 days following completion of treatment.
Who cannot join
- Received any anti-tumor treatment within the 4 weeks prior to study drug administration. The anti-tumor treatment includes surgery, ethanol injection, radiofrequency ablation, trans-arterial chemoembolization, intrahepatic chemotherapy, chemotherapy, biotherapy, immunotherapy, hormone, or radiotherapy.
- Received a systemic treatment of glucocorticoid (Prednisone > 10 mg/day or equivalent dose of a similar medicine) or other immunosuppressant treatment 14 days prior to study drug administration。
- Administration of immune-regulating medicines within 14 days prior to study drug administration of the investigational drug。
- Administration of live-attenuated vaccines within 4 weeks prior to study drug administration。
- Previously treated with oncolytic viruses or other gene therapies.
- Received treatment of unapproved investigational drugs within 4 weeks prior to study drug administration.
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- Currently participating in another clinical study, except for an observational or genetic (non-interventional) clinical study or a follow-up period.
- Had major organ surgery (excluding biopsy) or had significant trauma within 4 weeks prior to study drug administration.
- An adverse event from the previous anti-tumor therapy that has not resolved to ≤ Grade 1 or stabilized according to NCI-CTCAE v5.0, except for the adverse event of non-risk toxicity as judged by the investigator and sponsor.
- Participants with clinical symptoms of central nervous system metastasis or meningeal metastasis, or other evidence demonstrating the central nervous system metastasis or meningeal metastasis has not been controlled.
- History of meningococcal disease.
- Evidence of uncontrolled severe comorbidity that may affect the participant's compliance with the study protocol, including severe liver disease (e.g. severe esophageal and gastric varices that require interventional treatment, cirrhosis, hepatic encephalopathy, or venous syndrome).
- History of serious cardiovascular disease。
- Participants who have third interstitial fluid beyond clinical control judged by the investigator.
- History of tuberculosis infection or immunodeficiency, including participants who have tested positive for the human immunodeficiency virus (HIV) antibody.
- Participants who are allergic to any component of the SynOV1.1 drug product.
- Participants who are suffering from a known mental illness or substance abuse that may affect the objectivity of the trial.
- Female participants who are pregnant, lactating, or who plan to get pregnant or to breastfeed during the trial.
- Other reasons as judged by the investigator, including but not limited to highly vascularized tumors, exogenous, adjacent to necrotic areas, liver cysts, tumor site at the location with high risk of adverse events or not suitable for intratumoral injection, or tumor that will enhance the contraindications of CT/ MRI examination.
- A significant bleeding event, as assessed by the investigator, that occurring within 12 months prior to study drug administration may increase the risk of intratumoral injection procedures.
- Participants who cannot discontinue anticoagulant or antiplatelet medications prior to the intratumoral injection of SynOV1.1.
- Participants who require treatment for active systemic infection.
- Participants who have been diagnosed with bile duct cancer, bile duct liver cancer, fibrolamellar carcinoma, or hepatoblastoma based on histological finding.
- Participants who have a severe inflammatory skin disease that currently requires medication or who have a history of severe eczema that requires medication.
- Participants who received or plan to receive an organ transplant, such as a liver transplantation.
- Participants who carry another type of tumor that has required active treatment in the past 5 years.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130012
Yi Ren, Bachelor, 17390905515, y.ren@syngen.tech
About this study
Official title: An Open-label Phase I Study to Evaluate the Safety, Tolerability and Efficacy of SynOV1.1 Recombinant Oncolytic Adenovirus Injection as Monotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
This is a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors.
Read the detailed description
Part 1 ( single dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. 3 dose level (3 × 10^11 Vp, 1 × 10^12 Vp, 3 × 10^12 Vp) will be evaluated.
Part 2 (multiple dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. Participants will receive administration bi weekly. 2 dose level will be evaluated based on part 1 result.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- SynOV1.1
- Keywords
- Hepatocellular Carcinoma
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SynOV1.1Biological
SynOV1.1 will be administered intratumorally.
| Study group | Role | What they receive |
|---|---|---|
| SynOV1.1 Injection | Experimental | Not described Receives: Biological: SynOV1.1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The dose-limiting toxicities (DLTs) of SynOV1.1 in patients with HCC
Incidence and nature of DLT of SynOV1.1 in in patients with HCC, graded according to NCI CTCAE v5
Measured: 30 months
The maximum-tolerated dose (MTD) of SynOV1.1 in patients with HCC
MTD for patients with HCC received SynOV1.1 treatment.
Measured: 30 months
The response rate of patients with HCC receiving SynOV1.1
response rate based on RECIST ver. 1.1
Measured: 30 months
Secondary outcomes (3)
The biodistribution of SynOV1.1，as determined by the concentration of SynOV1.1 in blood of participating patients.
The concentration of SynOV1.1 in blood of participating patients will be measured by QT-PCR.
Measured: 30 months
The immunogenicity of SynOV1.1, as determined by quantitation of neutralizing antibodies in blood of participating patients.
The quantitation of neutralizing antibodies in blood of participating patients will be measured by CPE.
Measured: 30 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Determine the number of participants who received SynOV1.1 in combination with Atezolizumab treatment with treatment-related adverse events, as assessed by the CTCAE v5.0
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start23 Jun 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Syngentech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yanhua Ding, MD, Principal investigator, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04612504
- Sponsor's protocol ID
- Syngentech-SynOV1.1-101
- Status last verified
- Jan 2023
- First submitted
- 16 Oct 2020
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Phase I Study to Evaluate the Safety, Tolerability and Efficacy of SynOV1.1 Recombinant Oncolytic Adenovirus Injection as Monotherapy in Participants With Locally Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT04612504
- Acronym / sponsor ID
- Syngentech-SynOV1.1-101
- Conditions
- Hepatocellular Carcinoma
- Keywords
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Beijing Syngentech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Nov 2020 (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 a Phase I, open-label, multicenter study to characterize safety and tolerability, evaluate biodistribution, biological effects and immunogenicity, and evaluate the preliminary clinical efficacy of SynOV1.1 in participants with AFP positive solid tumors.
Detailed description
Part 1 ( single dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. 3 dose level (3 × 10^11 Vp, 1 × 10^12 Vp, 3 × 10^12 Vp) will be evaluated.
Part 2 (multiple dose escalation) is designed to determine the pharmacodynamics of SynOV1.1 as well as type and severity of toxicity based on safety and tolerability assessments. Participants will receive administration bi weekly. 2 dose level will be evaluated based on part 1 result.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SynOV1.1 Injection | Experimental | Biological: SynOV1.1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntarily participates in the clinical trial study; fully understands the study and signs the ICF; and is willing to follow and will be able to complete all trial procedures.
- Is ≥18 years old when signing ICF; male or female.
- Has locally advanced or metastatic AFP-positive solid tumorsthat has relapsed or is refractory to standard cancer therapies, or where no standard therapies are available. AFP positive means that serum samples have levels of AFP> 20 ng/ml during screening or an AFP immunohistochemistry [IHC] test of previous tumor tissue samples was positive.
- Has at least one lesion that cannot be surgically removed which can be injected directly or through ultrasound (US) and/or computer tomography (CT) guidance.
- Has at least one measurable tumor lesion.
Key exclusion criteria (26 listed)
- Received any anti-tumor treatment within the 4 weeks prior to study drug administration. The anti-tumor treatment includes surgery, ethanol injection, radiofrequency ablation, trans-arterial chemoembolization, intrahepatic chemotherapy, chemotherapy, biotherapy, immunotherapy, hormone, or radiotherapy.
- Received a systemic treatment of glucocorticoid (Prednisone > 10 mg/day or equivalent dose of a similar medicine) or other immunosuppressant treatment 14 days prior to study drug administration。
- Administration of immune-regulating medicines within 14 days prior to study drug administration of the investigational drug。
- Administration of live-attenuated vaccines within 4 weeks prior to study drug administration。
- Previously treated with oncolytic viruses or other gene therapies.
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 |
|---|---|---|
| SynOV1.1SynOV1.1 will be administered intratumorally. | Biological | SynOV1.1 Injection |
Primary outcome
The dose-limiting toxicities (DLTs) of SynOV1.1 in patients with HCC
Time frame: 30 months
Incidence and nature of DLT of SynOV1.1 in in patients with HCC, graded according to NCI CTCAE v5
The maximum-tolerated dose (MTD) of SynOV1.1 in patients with HCC
Time frame: 30 months
MTD for patients with HCC received SynOV1.1 treatment.
The response rate of patients with HCC receiving SynOV1.1
Time frame: 30 months
response rate based on RECIST ver. 1.1
3 secondary outcomes
The biodistribution of SynOV1.1，as determined by the concentration of SynOV1.1 in blood of participating patients.
Time frame: 30 months
The immunogenicity of SynOV1.1, as determined by quantitation of neutralizing antibodies in blood of participating patients.
Time frame: 30 months
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
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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.
Yanhua Ding, MD principal investigator
The First Hospital of Jilin University
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 SynOV1.1 in people with Hepatocellular Carcinoma, run by Beijing Syngentech Co., Ltd. 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 12 inclusion and 26 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 2 Feb 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 Yi Ren, Bachelor (17390905515, y.ren@syngen.tech), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The dose-limiting toxicities (DLTs) of SynOV1.1 in patients with HCC (time frame: 30 months). The study lists 3 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 2 Feb 2023.