Phase 1 Study to Assess Safety and Early Effects of a Single Injection of IntraGels Cisplatin-loaded Gel TumoCure in Adults with Progressive or Radio-resistant Head and Neck Cancer

What this Trial Is About

Researchers are studying a new treatment called TumoCure, a polymer-based gel loaded with Cisplatin, designed for patients with progressive or radio-resistant primary head and neck cancer who have no other treatment options due to ineffectiveness, intolerance, or inapplicability of standard therapies. This phase Ib, open-label, multi-center study evaluates the safety, tolerability, and initial effectiveness of a single intra-tumoral injection of TumoCure in these patients. Participants will receive one injection of TumoCure directly into their tumor, containing 100 mg of Cisplatin within the polymer gel. This single treatment aims to deliver localized chemotherapy to the tumor site. The study is conducted across multiple centers and involves close monitoring of patients following the injection. During the study, participants will be monitored for serious adverse events over 90 days to assess safety. Researchers will also measure changes in tumor size using ultrasound, MRI, or CT scans to evaluate treatment effect. Subjects must comply with study procedures and provide informed consent. The study includes patients aged 18 to 80 years and lasts at least 90 days from treatment to primary outcome assessment.

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