Advanced Solid TumorPhase 1NCT05228119
A Study of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor in Patients With Advanced Solid Tumors
A Phase 1 study testing Oncolytic Virus Injection(RT-01) in people with Advanced Solid Tumor, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Oncolytic Virus Injection(RT-01)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2022to 1 Oct 2023
- 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 aged ≥ 18 years;
- Subjects must have histologically or cytologically confirmed diagnosis of advanced solid tumor(s) who have failed in standard therapy (disease progression or intolerance) and no effective treatment, or have no standard therapy, or have failed to obtain standard treatment due to objective conditions ;
- Subjects have At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- ECOG score of 0 ~ 2;
- Adequate bone marrow, hepatic and renal and coagulation function;
- Women of childbearing age who have a negative pregnancy test within 7 days before treatment. Female patients of childbearing age, and male patients with partners of childbearing age must agree to use at least one medically recognized contraceptive method during study treatment and within at least 6 months after the last dose of investigational drug;
- Voluntarily participated in this study, signed the informed
Who cannot join
- Subjects with known brain metastasis and/or clinically history tumor brain of metastasis；
- Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration；
- Subjects who have participate in another interventional study within 4 weeks before RT-01 administration；
- Subjects who have had major surgery within 4 weeks before RT-01 administration；
- Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids；
- Subjects who have participate in another oncolytic virus study within 8 weeks before RT-01 administration；
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- Subjects received live vaccines within 7 days before RT-01 administration；
- Subjects received Antiviral drugs within 2 weeks, long-acting interferon within 4 weeks before RT-01 administration；
- Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia);
- Subjects who have uncontrolled active infection;
- Subjects with known positive history of human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);
- Subjects who have active hepatitis;
- Subjects who have serious cardiovascular system disorders history;
- Subjects with active autoimmune diseases or history of autoimmune diseases that may relapse;
- Subjects having any serious uncontrolled disease or in other conditions that would preclude them from receiving study treatment and are considered unsuitable for this study in the opinion of the investigator;
- Subjects in other conditions that are considered unsuitable for this study by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221006
Han Zhengxiang, MD, 18052268612, cnhzxyq@163.com
About this study
Official title: A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor (Nivolumab) in Patients With Advanced Solid Tumors
This is a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors.
The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 inhibitor.
Read the detailed description
This is an investigator initiated , single-arm, open-label study of RT-01 as a single agent given via Intravenous injection（IV）with or without Intratumoral injection（IT） in combination with IV Nivolumab in patients with advanced solid tumors.
This study is planned to enroll 40-50 patients with advanced solid tumors. RT-01 will be administered as a single dose on day 1, Nivolumab will be administered intravenously every 3 weeks starting on day 5.
The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 Inhibitor (Nivolumab).
- Conditions
- Advanced Solid Tumor
- Being tested
- Oncolytic Virus Injection(RT-01)
- Keywords
- RT-01, Oncolytic Virus, PD-1 Inhibitor, immunotherapy, immune Checkpoint Inhibitors, Intravenous Injection, Intratumoral injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oncolytic Virus Injection(RT-01)Biological
Intravenous injection with or without intratumoral injection of a single dose of RT-01 and intravenous infusion of Nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Oncolytic Virus Injection(RT-01) | Experimental | RT-01 will be administered either intravenously or with a combination of intravenously and intratumorally on day 1.
Nivolumab will be administered intravenously every 3 weeks starting on day 5. Receives: Biological: Oncolytic Virus Injection(RT-01) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Graded according to the NCI CTCAE version 5.0.
Measured: Up to 6 months
Objective response rate
Assess the proportion of patients who achieved complete or partial response
Measured: Up to 2 years
Disease control rate
Assess the proportion of patients who achieved complete or partial or stable response
Measured: Up to 2 years
The changes from baseline of lymphocyte counts
The changes from baseline of Peripheral blood lymphocyte subtypes counts
Measured: Up to 28 days
The concentration of antiviral antibody.
The concentration of antiviral antibody of RT-01 in blood
Measured: Up to 22 Weeks
The rate of subjects with viral shedding of RT-01
The rate of subjects with viral RNA in the secretion
Measured: Up to 22 Weeks
The Tmax of Viral RNA in blood
Time to peak viral RNA concentration
Measured: Up to 22 Weeks
The Cmax of Viral RNA in blood
The peak viral RNA concentration
Measured: Up to 22 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start4 Jan 2022
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05228119
- Sponsor's protocol ID
- LWY21076CXY
- Status last verified
- May 2022
- First submitted
- 3 Jan 2022
- Last updated
- 9 May 2022
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open-Label, Exploratory Study to Evaluate Safety and Efficacy of Oncolytic Virus Injection (RT-01) in Combination With PD-1 Inhibitor (Nivolumab) in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05228119
- Acronym / sponsor ID
- LWY21076CXY
- Conditions
- Advanced Solid Tumor
- Keywords
- RT-01, Oncolytic Virus, PD-1 Inhibitor, immunotherapy, immune Checkpoint Inhibitors, Intravenous Injection, Intratumoral injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 8 Feb 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 a single-arm, open-label, exploratory study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in combination with PD-1 inhibitor (Nivolumab) in patients with advanced solid tumors.
The purpose of this study is to evaluate the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 inhibitor.
Detailed description
This is an investigator initiated , single-arm, open-label study of RT-01 as a single agent given via Intravenous injection（IV）with or without Intratumoral injection（IT） in combination with IV Nivolumab in patients with advanced solid tumors.
This study is planned to enroll 40-50 patients with advanced solid tumors. RT-01 will be administered as a single dose on day 1, Nivolumab will be administered intravenously every 3 weeks starting on day 5.
The purpose of this study is to assess the safety and tolerability, antitumor activity, The immunoreactivity, The immunogenicity, pharmacokinetics and virus shedding of RT-01 in combination with PD-1 Inhibitor (Nivolumab).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oncolytic Virus Injection(RT-01) | Experimental | Biological: Oncolytic Virus Injection(RT-01)RT-01 will be administered either intravenously or with a combination of intravenously and intratumorally on day 1. Nivolumab will be administered intravenously every 3 weeks starting on day 5. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥ 18 years;
- Subjects must have histologically or cytologically confirmed diagnosis of advanced solid tumor(s) who have failed in standard therapy (disease progression or intolerance) and no effective treatment, or have no standard therapy, or have failed to obtain standard treatment due to objective conditions ;
- Subjects have At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) (non-nodal lesions with longest diameter ≥ 10 mm, or nodal lesions with short diameter ≥ 15 mm);
- ECOG score of 0 ~ 2;
- Adequate bone marrow, hepatic and renal and coagulation function;
Key exclusion criteria (16 listed)
- Subjects with known brain metastasis and/or clinically history tumor brain of metastasis；
- Subjects who have received anti-tumor therapy such as chemotherapy, radiotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy, etc within 2 weeks before RT-01 administration；
- Subjects who have participate in another interventional study within 4 weeks before RT-01 administration；
- Subjects who have had major surgery within 4 weeks before RT-01 administration；
- Patients in any condition requiring systemic treatment with corticosteroids (prednisone > 10 mg/day or equivalent of the similar drug) or other immunosuppressive agents within 14 days before RT-01 administration, but currently or previously treated with any of the following steroid regimens, were included: Topical, ophthalmic, intra-articular, intranasal, or inhaled corticosteroids with minimal systemic absorption; Prophylactic short-term use of corticosteroids；
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 Injection(RT-01)Intravenous injection with or without intratumoral injection of a single dose of RT-01 and intravenous infusion of Nivolumab | Biological | Oncolytic Virus Injection(RT-01) |
Primary outcome
Incidence of adverse events
Time frame: Up to 6 months
Graded according to the NCI CTCAE version 5.0.
Objective response rate
Time frame: Up to 2 years
Assess the proportion of patients who achieved complete or partial response
Disease control rate
Time frame: Up to 2 years
Assess the proportion of patients who achieved complete or partial or stable response
The changes from baseline of lymphocyte counts
Time frame: Up to 28 days
The changes from baseline of Peripheral blood lymphocyte subtypes counts
The concentration of antiviral antibody.
Time frame: Up to 22 Weeks
The concentration of antiviral antibody of RT-01 in blood
The rate of subjects with viral shedding of RT-01
Time frame: Up to 22 Weeks
The rate of subjects with viral RNA in the secretion
The Tmax of Viral RNA in blood
Time frame: Up to 22 Weeks
Time to peak viral RNA concentration
The Cmax of Viral RNA in blood
Time frame: Up to 22 Weeks
The peak viral RNA concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- 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.
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 Injection(RT-01) in people with Advanced Solid Tumor, run by The Affiliated Hospital of Xuzhou Medical University 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 7 inclusion and 16 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 9 May 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?
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 Han Zhengxiang, MD (18052268612, cnhzxyq@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (time frame: Up to 6 months). The study lists 8 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 9 May 2022.