Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT05961111

A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors

Led by Shanghai Yunying Medical Technology · Updated on 2023-07-27

20

Participants Needed

1

Research Sites

153 weeks

Total Duration

On this page

Sponsors

S

Shanghai Yunying Medical Technology

Lead Sponsor

L

Linyi People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

20 participants are expected to be enrolled for this open,Single-armed clinical trial to evaluate the safety and efficacy of the recombinant herpes simplex virus Ⅰ, R130 in patients with advanced solid tumors.

CONDITIONS

Official Title

A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with solid tumors confirmed by histology or cytology
  • Failed standard treatment or unwilling to receive other antitumor therapies
  • Age between 18 and 75 years
  • ECOG performance status score of 0 to 2
  • Expected survival of at least 3 months
  • At least one measurable lesion suitable for intratumoral or intraperitoneal injection
  • Adequate organ function with laboratory values within specified limits for blood counts, kidney and liver function, and coagulation
  • No absolute or relative bleeding contraindications
  • Women of childbearing potential must have a negative pregnancy test and agree to use reliable contraception during and for 180 days after the trial
  • Voluntary informed consent and good compliance
Not Eligible

You will not qualify if you...

  • History of serious adverse reactions to immunotherapy
  • Severe or uncontrolled diseases such as uncontrolled hypertension, significant heart disease, severe infections, or immune deficiencies
  • Urine protein abnormalities exceeding specified limits
  • Past history of type I diabetes or HIV infection
  • Severe thyroid or cortisol abnormalities or active autoimmune diseases requiring systemic therapy
  • Severe prior lung changes
  • Active tuberculosis with strong positive OT test
  • Active bleeding or severe blood clotting problems
  • Antitumor therapy within 4 weeks before first dose
  • Unresolved toxicities from previous cancer treatments above grade 1
  • Active hepatitis B, hepatitis C, immunodeficiency virus, or other significant infections
  • Recent major surgery with unhealed wounds within 4 weeks
  • Pregnancy, breastfeeding, or planning pregnancy within six months
  • Any other condition making participation unsuitable as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Linyi Central Hospital

Linyi, Shandong, China, 276000

Actively Recruiting

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Research Team

F

Feng Pan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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A Clinical Study on Oncolytic Virus Injection (R130 OV) for the Treatment of Advanced Solid Tumors | DecenTrialz