A Clinical Study of Intratumoral Administration of RT-01 in Patients With Advanced Solid Tumors

NCT05136937 | Unknown Phase 1

• 1 other identifier: LWY21076C1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Solid Tumor; Advanced Cancer

Keywords

RT-01; immunotherapy; intratumoral injection; oncolytic virus

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities (DLT)

  To define the maximum tolerated dose (MTD) of intratumoral administration of RT-01 injection in humans with malignant tumors.

  Up to 28 days

Secondary Outcomes (8)

• Safety and tolerability assessed by Adverse Events (AEs)

  Up to 6 months

• Number of participants with laboratory value abnormalities and/or adverse events

  Up to 6 months

• Number of participants with vital sign abnormalities and /or adverse event

  Up to 6 months

• Safety assessed by 12- lead electrocardiograms (ECGs) adverse events

  Up to 6 months

• To evaluate the efficacy assessed per RECIST and iRECIST

  Up to 2 years form first dose of RT-01

Study Arms (1)

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

Biological: Oncolytic Virus Injection(RT-01)

Interventions

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

Oncolytic virus injection(RT-01) for patients with advanced solid tumors

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;
• 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.

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: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Administered by intratumoral injection for 3 dose cohorts: 1×10\^7 TCID50/mL, 1×10\^8 TCID50/mL and 5×10\^8 TCID50/mL

Study Record Dates

• First Submitted: November 1, 2021
• First Posted: November 30, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2023
• Last Updated: January 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)