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Safety, Tolerability and Pharmacokinetics Investigation of Stimotimagene Copolymerplasmid

NCT05578820 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2024-07-01

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and tolerability of different doses and administration regimens of Stimotimagene copolymerplasmid in patients with histologically confirmed diagnosis of solid tumor and/or its metastases.

Conditions

  • Sarcoma
  • Melanoma
  • Squamous Cell Carcinoma of Head and Neck
  • Breast Neoplasms
  • Uterine Cervical Neoplasms
  • Vulvar Neoplasms
  • Penile Neoplasms
  • Anus Neoplasms

Interventions

BIOLOGICAL

Stimotimagene copolymerplasmid

Gene therapy drug, Intratumoral administration

DRUG

Ganciclovir

Antiviral drug, Intravenous administration

Sponsors & Collaborators

  • Gene Surgery LLC

    lead INDUSTRY

Principal Investigators

  • Irina Alekseenko

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2024-04-11
Completion
2024-04-11

Countries

  • Russia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05578820 on ClinicalTrials.gov