- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05122572
RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors
January 19, 2022 updated by: Wuxi People's Hospital
An Open-label Clinical Study to Evaluate the Safety and Efficacy of Intravenous With and Without Intratumoral Oncolytic Virus Injection (RT-01) Combined With or Without Immune Checkpoint Inhibitors (Nivolumab) in the Treatment of Patients With Advanced Solid Tumors
This is a single-arm, open-lable study to determine the safety, tolerability and preliminary efficacy of oncolytic virus injection (RT-01) combined with or without immune checkpoint inhibitors (Nivolumab) in the treatment of patients with advanced solid tumors.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
To evaluate the safety, tolerability, efficacy, immunoreactivity, immunogenicity, pharmacokinetics and virus shedding of RT-01 injection given via Intravenous with or without Intratumoral administration combined with immune checkpoint inhibitors Nivolumab in the treatment of patients with advanced solid tumors.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
-
Wuxi, Jiangsu, China, 214043
- Recruiting
- Wuxi People's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female aged ≥ 18 years;
- Have a histopathologically or cytologically confirmed dagnosis of advanced solid tumors and no existing options are felt to provide clinical benefit;
- 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 cardiovascular 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;
- Ability to provide written informed consent.
Exclusion Criteria:
- 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;
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intravenous Injection
Intravenous with or without Intratumoral RT-01 in the treatment of patients with advanced solid tumors combined with or without Nivolumab in the treatment of patients with advanced solid tumors
|
Intravenous injection of RT-01 with or without Nivolumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose Limiting Toxicities (DLT)
Time Frame: Up to 28 days
|
Graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Defined as the highest safety-tolerated dose level where at most one patient out of six experiences dose limiting toxicities (DLT) with the next higher dose level having at least 2 of 6 patients who have experienced DLT.
|
Up to 28 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 6 months
|
Graded according to the NCI CTCAE version 5.0.
|
Up to 6 months
|
Overall response rate (ORR)
Time Frame: Up to 6 months
|
Proportion of patients in the analysis population who have complete response (CR) or partial response (PR) based on RECIST v1.1 imaging.
|
Up to 6 months
|
Disease Control Rate (DCR)
Time Frame: Up to 6 months
|
Proportion of patients in the analysis population who have complete response (CR), partial response (PR) or stable disease (SD) based on RECIST v1.1 imaging.
|
Up to 6 months
|
Overall Survival (OS)
Time Frame: Up to 6 months
|
Survival time is defined as the time from registration to death due to any cause.
|
Up to 6 months
|
Progression Free Survival (PFS)
Time Frame: Up to 6 months
|
Progression-free survival is defined as the time from registration to the earliest date documentation of disease progression or death due to any cause.
|
Up to 6 months
|
Viral replication and shedding in blood, urine and buccal swabs
Time Frame: Up to 6 months
|
Assessed via quantitative reverse transcriptase polymerase chain reaction.
|
Up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2021
Primary Completion (Anticipated)
June 1, 2022
Study Completion (Anticipated)
June 1, 2023
Study Registration Dates
First Submitted
November 2, 2021
First Submitted That Met QC Criteria
November 15, 2021
First Posted (Actual)
November 16, 2021
Study Record Updates
Last Update Posted (Actual)
January 20, 2022
Last Update Submitted That Met QC Criteria
January 19, 2022
Last Verified
November 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LWY21076C2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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