Solid TumorPhase 1NCT05136937
A Clinical Study of Intratumoral Administration of RT-01 in Patients With Advanced Solid Tumors
A Phase 1 study testing Oncolytic Virus Injection(RT-01) in people with Solid Tumor and Advanced Cancer, run by Wuxi People's Hospital at 1 site in China.
Trial summary
This is an open-label, dose escalation study of the safety and tolerability of oncolytic virus injection(RT-01) when administered via intratumoral injection 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
- Solid Tumor, Advanced Cancer
- 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
- 18 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2021to 1 Jun 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) and have progressed on or is not eligible for available standard therapy;
- 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 consent form, had good compliance, and cooperated with the follow-up.
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 4 weeks；
- Subjects who have participate in another interventional study while receiving study IP within 4 weeks；
- Subjects who have had major surgery ≤ 4 weeks of dosing；
- 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 prior to investigational drug 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;
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- Prophylactic short-term (≤ 7 days) use of corticosteroids (e.g., allergy to contrast media) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity caused by contact allergens)
- Subjects received live vaccines within 7 days of initiation of study treatment；
- Subjects with adverse reactions caused by previous anti-tumor treatment not recovered to (CTCAE 5.0) grade 1 (except alopecia)；
- Subjects who have any 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
Wuxi People's Hospital
Wuxi, Jiangsu, 214043
Peihua Lu, MD, 13621500031, 13625653@qq.com
About this study
Official title: An Open-Label, Dose Escalation Study of the Safety and Tolerability of Oncolytic Virus Injection(RT-01) When Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
This is an open-label, dose escalation study of the safety and tolerability of oncolytic virus injection(RT-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 RT-01 and to determine the recommended phase 2 dose (RP2D) for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of RT-01.
Read the detailed description
This is an investigator initiated , open-label, study of RT-01 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 RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 7-18 evaluable participants enrolled.
The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of RT-01 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
- Solid Tumor, Advanced Cancer
- Being tested
- Oncolytic Virus Injection(RT-01)
- Keywords
- RT-01, immunotherapy, intratumoral injection, oncolytic virus
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
Administered by intratumoral injection for 3 dose cohorts: 1×10^7 TCID50/mL, 1×10^8 TCID50/mL and 7×10^8 TCID50/mL
| Study group | Role | What they receive |
|---|---|---|
| Oncolytic virus injection(RT-01) for patients with advanced solid tumors | Experimental | Intratumoral administration of RT-01 as single agent for patients with advanced solid tumors.The injection dose of RT-01 was determined by the lesion size:
1. mL for lesion length <1.5 cm;
2. mL for lesion length between 1.5 cm and 2.5 cm;
3. mL for lesion length between 2.5 cm and 5.0 cm;
4. mL for lesion length between >5 cm Receives: Biological: Oncolytic Virus Injection(RT-01) |
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 RT-01 injection in humans with malignant tumors.
Measured: Up to 28 days
Secondary outcomes (8)
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: 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
Number of participants with vital sign abnormalities and /or adverse event
Number of participants with potentially clinically significant vital sign values
Measured: Up to 6 months
Safety assessed by 12- lead electrocardiograms (ECGs) adverse events
12-lead ECGs will be read and assessed locally. Any clinically significant adverse changes on the ECG will be reported as Adverse Events
Measured: Up to 6 months
To evaluate the efficacy assessed per RECIST and iRECIST
Changes in tumor size and occurrence of metastases was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response is disappearance of all target lesions. Partial Response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). And Stable Disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of diameters while on study.
Measured: Up to 2 years form first dose of RT-01
Number of Participants With Response
Detection of increased systemic immune Response markers in peripheral blood mononuclear cells
Measured: at baseline, 2, 4, 7, 14, 28 days after injection
Viral shedding of RT-01 in blood
Viral DNA will be analyzed by quantitative polymerase chain reaction (qPCR).
Measured: Up to 6 months
Presence of neutralizing antibodies of antidrug antibodies (ADAs) development
To evaluate the immunogenicity of RT-01 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 posted30 Nov 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Sequential
- Model description
- Administered by intratumoral injection for 3 dose cohorts: 1×10\^7 TCID50/mL, 1×10\^8 TCID50/mL and 5×10\^8 TCID50/mL
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuxi People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05136937
- Sponsor's protocol ID
- LWY21076C1
- Status last verified
- Jan 2022
- First submitted
- 1 Nov 2021
- Last updated
- 31 Jan 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 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose Escalation Study of the Safety and Tolerability of Oncolytic Virus Injection(RT-01) When Administered Via Intratumoral Injection in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05136937
- Acronym / sponsor ID
- LWY21076C1
- Conditions
- Solid Tumor, Advanced Cancer
- Keywords
- RT-01, immunotherapy, intratumoral injection, oncolytic virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Wuxi People's HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Nov 2021 (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 oncolytic virus injection(RT-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 RT-01 and to determine the recommended phase 2 dose (RP2D) for further study. The study will also evaluate antitumor activity, objective response rate, pharmacokinetics and virus shedding of RT-01.
Detailed description
This is an investigator initiated , open-label, study of RT-01 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 RT-01. Total enrollment will depend on the toxicities and/or activity observed, with approximately 7-18 evaluable participants enrolled.
The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of intratumoral administration of RT-01 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
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Administered by intratumoral injection for 3 dose cohorts: 1×10^7 TCID50/mL, 1×10^8 TCID50/mL and 5×10^8 TCID50/mL
| Arm | Type | Receives |
|---|---|---|
| Oncolytic virus injection(RT-01) for patients with advanced solid tumors | Experimental | Biological: Oncolytic Virus Injection(RT-01)Intratumoral administration of RT-01 as single agent for patients with advanced solid tumors.The injection dose of RT-01 was determined by the lesion size: 1. mL for lesion length <1.5 cm; 2. mL for lesion length between 1.5 cm and 2.5 cm; 3. mL for lesion length between 2.5 cm and 5.0 cm; 4. mL for lesion length between >5 cm |
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) and have progressed on or is not eligible for available standard therapy;
- 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 4 weeks；
- Subjects who have participate in another interventional study while receiving study IP within 4 weeks；
- Subjects who have had major surgery ≤ 4 weeks of dosing；
- 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 prior to investigational drug administration, but currently or previously treated with any of the following steroid regimens, were included:
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)Administered by intratumoral injection for 3 dose cohorts: 1×10^7 TCID50/mL, 1×10^8 TCID50/mL and 7×10^8 TCID50/mL | Biological | Oncolytic virus injection(RT-01) for patients with advanced 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 RT-01 injection in humans with malignant tumors.
8 secondary outcomes
Safety and tolerability assessed by Adverse Events (AEs)
Time frame: Up to 6 months
Number of participants with laboratory value abnormalities and/or adverse events
Time frame: Up to 6 months
Number of participants with vital sign abnormalities and /or adverse event
Time frame: Up to 6 months
Safety assessed by 12- lead electrocardiograms (ECGs) adverse events
Time frame: Up to 6 months
To evaluate the efficacy assessed per RECIST and iRECIST
Time frame: Up to 2 years form first dose of RT-01
Number of Participants With Response
Time frame: at baseline, 2, 4, 7, 14, 28 days after injection
Viral shedding of RT-01 in blood
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 31 Jan 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 Solid Tumor and Advanced Cancer, run by Wuxi People's 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 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 31 Jan 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 Peihua Lu, MD (+86 13621500031, 13625653@qq.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). 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 31 Jan 2022.