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

  • STATUS
    Recruiting
  • participants needed
    36
  • sponsor
    Wuxi People's Hospital
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Updated on 14 March 2022
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Summary

This is an open-label, dose escalation study of the safety and tolerability of oncolytic virus injection(RT-01) when administered via Intravenous 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.

Description

This is an investigator initiated , open-label, study of RT-01 given via intratumoral (IT) injection as a single agent and in combination with IV PD-1/PD-L1 in participants with advanced solid tumors.
The study consists of two parts：In the single agent dose escalation part (Part A), four doses (1×10^7 TCID50, 1×10^8 TCID50, 3×10^8 TCID50, 1×10^9 TCID50) of RT-01 will be delivered Intravenous as single agent to observe the DLTs and to identify the MTD. Part A is a single agent dose escalation which will use a 3+3 design to evaluate escalating doses of RT-01.
Once the IV RT-01 MTD is established, the Part B part of the study will begin. Part B is IV RT-01 in combination with IV PD-1/PD-L1 dose escalation which will use a 3+3 design to evaluate escalating doses of IV RT in combination with IV pembrolizumab.
Total enrollment will depend on the toxicities and/or activity observed, with approximately 16-36 evaluable participants enrolled.
The primary study objective is to determine the safety, tolerability, and maximum tolerated dose (MTD) of Intravenous administration of RT-01 as a single agent and in combination with immune checkpoint inhibitors. 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.

Details
Condition Solid Tumor, Advanced Cancer
Age 18years or above
Treatment Oncolytic Virus Injection(RT-01), Oncolytic Virus Injection(RT-01)+pembrolizumab (PD-1)
Clinical Study IdentifierNCT05122572
SponsorWuxi People's Hospital
Last Modified on14 March 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

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
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