Clinical trial NCT05122572: RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Advanced Solid Tumor
Keywords: RT-01
Oncolytic Virus Injection
Inmmune Checkpoint Inhibitors
Intravenous Injection
Intratumoral Injection
Lead sponsor: Wuxi People's Hospital
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limiting Toxicities (DLT)
timeFrame: Up to 28 days
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 6 months
measure: Overall response rate (ORR)
timeFrame: Up to 6 months
measure: Disease Control Rate (DCR)
timeFrame: Up to 6 months
measure: Overall Survival (OS)
timeFrame: Up to 6 months
measure: Progression Free Survival (PFS)
timeFrame: Up to 6 months
measure: Viral replication and shedding in blood, urine and buccal swabs
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Wuxi
country: China
facility: Wuxi People's Hospital
state: Jiangsu
Study officials:
References: