RT-01 Monotherapy and in Combination With Nivolumab in Patients With Advanced Solid Tumors

NCT05122572 | Unknown Phase 1

• 1 other identifier: LWY21076C2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Keywords

RT-01; Oncolytic Virus Injection; Inmmune Checkpoint Inhibitors; Intravenous Injection; Intratumoral Injection

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLT)

  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 Outcomes (6)

• Incidence of adverse events

  Up to 6 months

• Overall response rate (ORR)

  Up to 6 months

• Disease Control Rate (DCR)

  Up to 6 months

• Overall Survival (OS)

  Up to 6 months

• Progression Free Survival (PFS)

  Up to 6 months

Study Arms (1)

Intravenous Injection

EXPERIMENTAL

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

Biological: Oncolytic Virus Injection (RT-01）

Interventions

Oncolytic Virus Injection (RT-01） BIOLOGICAL

Intravenous injection of RT-01 with or without Nivolumab

Intravenous Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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；

Sponsors & Collaborators

• Wuxi People's Hospital: lead

Study Sites (1)

Wuxi People's Hospital

Wuxi, Jiangsu, 214043, China

RECRUITING

Central Study Contacts

Peihua Lu, MD

CONTACT

+86 13621500031; 13625653@qq.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 16, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: January 20, 2022

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)