Advanced Solid TumorPhase 1NCT05205421
A Study of Oncolytic Virus Injection (RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 1 study testing Oncolytic Virus Injection(RT-01) in people with Advanced Solid Tumor, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer. 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
- 20 participants
- Where
- 1 siteChina
- Study dates
- 18 Jan 2022to Jan 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
- 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 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;
- Subjects received live vaccines within 7 days before RT-01 administration;
Show all 15Show fewer
- 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
First Affiliated Hospital Bengbu Medical College
Bengbu, Anhui, 233030
Zhou huan, MD, 13665527160, zhouhuanbest@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 Patients With Extensive-Stage Small Cell Lung Cancer
This is a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer.
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.
Read the detailed description
This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 as a single agent given via Intravenous injection in Patients With Extensive-Stage Small Cell Lung Cancer.
RT-01 will be administered as a single dose on day 1 in patients with advanced solid tumors. Durvalumab will be administered intravenously every 3 weeks starting on day 5 after RT-1 on day 1 for 4 cycles，then followed by every 4 weeks. This study is planned to enroll 10-20 patients with Extensive-Stage Small Cell Lung Cancer.
Considering the benefits of the subjects, the investigator deems that higher doses can be explored, then a higher-dose cohort will be carried out. 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.
- Conditions
- Advanced Solid Tumor
- Being tested
- Oncolytic Virus Injection(RT-01)
- Keywords
- RT-01, Oncolytic Virus, PD-L1 Inhibitor, immunotherapy, Intravenous Injection, Small-cell lung cancer
- Medical subject headings
- Small Cell Lung Carcinoma
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 a single dose of RT-01
| Study group | Role | What they receive |
|---|---|---|
| Oncolytic Virus Injection(RT-01) | Experimental | RT-01 will be administered by intravenously; 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
To evaluate the antitumor activity
To assessed per RECIST and iRECIST
Measured: Up to 2 years
The changes of the immunoreactivity during treatment.
Peripheral blood T lymphocyte subtype
Measured: Up to 28 days
To evaluate the immunogenicity of RT-01
Antiviral antibody
Measured: Up to 28 days
To evaluate the viral shedding of RT-01
Viral RNA
Measured: Up to 24 Weeks
The Cmax of Viral RNA
The maximum RNA peak concentration
Measured: Up to 24 Weeks
The Tmax of Viral RNA
The time of maximum RNA peak concentration
Measured: Up to 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2022
- Study start18 Jan 2022
- Primary completionJan 2023 (estimated)
- Study completionJan 2024 (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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Zishu, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205421
- Sponsor's protocol ID
- LWY21076CBY2
- Status last verified
- Aug 2022
- First submitted
- 19 Jan 2022
- Last updated
- 5 Aug 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 5 Aug 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 Patients With Extensive-Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05205421
- Acronym / sponsor ID
- LWY21076CBY2
- Conditions
- Advanced Solid Tumor
- Keywords
- RT-01, Oncolytic Virus, PD-L1 Inhibitor, immunotherapy, Intravenous Injection, Small-cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 25 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 a single-arm, open-label, clinical pharmacology study to evaluate safety and efficacy of oncolytic virus injection(RT-01) in Patients With Extensive-Stage Small Cell Lung Cancer.
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.
Detailed description
This is an investigator initiated , single-arm, open-label clinical pharmacology study of RT-01 as a single agent given via Intravenous injection in Patients With Extensive-Stage Small Cell Lung Cancer.
RT-01 will be administered as a single dose on day 1 in patients with advanced solid tumors. Durvalumab will be administered intravenously every 3 weeks starting on day 5 after RT-1 on day 1 for 4 cycles，then followed by every 4 weeks. This study is planned to enroll 10-20 patients with Extensive-Stage Small Cell Lung Cancer.
Considering the benefits of the subjects, the investigator deems that higher doses can be explored, then a higher-dose cohort will be carried out. 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.
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 by intravenously; |
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 (15 listed)
- 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;
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 a single dose of RT-01 | 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.
To evaluate the antitumor activity
Time frame: Up to 2 years
To assessed per RECIST and iRECIST
The changes of the immunoreactivity during treatment.
Time frame: Up to 28 days
Peripheral blood T lymphocyte subtype
To evaluate the immunogenicity of RT-01
Time frame: Up to 28 days
Antiviral antibody
To evaluate the viral shedding of RT-01
Time frame: Up to 24 Weeks
Viral RNA
The Cmax of Viral RNA
Time frame: Up to 24 Weeks
The maximum RNA peak concentration
The Tmax of Viral RNA
Time frame: Up to 24 Weeks
The time of maximum RNA peak concentration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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 First Affiliated Hospital of Bengbu 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 15 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 5 Aug 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 zhou huan, MD (13665527160, zhouhuanbest@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 7 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 5 Aug 2022.