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A Single Arm, Prospective, Open Label, Multi Center, Phase Ib Study to Evaluate the Safety, Tolerability and Initial Efficacy of a Single Intra-tumoral Injection of IntraGel's Polymer-based Cisplatin-loaded Gel (TumoCure) in Subjects With Progressive or Radio-resistant Primary Head and Neck Tumor

NCT05200650 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-10-08

No results posted yet for this study

Summary

IntraGel's polymer-based Cisplatin loaded Gel (TumoCure) is a single injectable compound, aimed at localized chemotherapy treatment. The treatment is offered to patients who currently have no other available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment

Conditions

Interventions

COMBINATION_PRODUCT

TumoCure

TumoCure is a polymer-based gel, loaded with Cisplatin in a dose of 100mg (10% w/w), injected to head and neck tumors locally in a single injection.

Sponsors & Collaborators

  • IntraGel Therapeutics

    lead INDUSTRY

Principal Investigators

  • Aharon Popovizer, MD · Head of Head and Neck Surgery Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2023-01-15
Primary Completion
2025-05-15
Completion
2025-07-01

Countries

  • Israel

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 NCT05200650 on ClinicalTrials.gov