Your session is about to expire
← Back to Search
Virus Therapy
A Clinical Study of Intratumoral Administration of RT-01 in Patients With Advanced Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by Wuxi People's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years form first dose of rt-01
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Solid Tumors
- Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years form first dose of rt-01
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years form first dose of rt-01
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Dose Limiting Toxicities (DLT)
Secondary study objectives
Number of Participants With Response
Number of participants with laboratory value abnormalities and/or adverse events
Number of participants with vital sign abnormalities and /or adverse event
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oncolytic virus injection(RT-01) for patients with advanced solid tumorsExperimental Treatment1 Intervention
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
Find a Location
Who is running the clinical trial?
Wuxi People's HospitalLead Sponsor
40 Previous Clinical Trials
30,229 Total Patients Enrolled