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Clinical Trials in Israel / NCT05200650
Recruiting Phase 1

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 · tracked via the Priya Life Science Israel tracker
Sponsor
IntraGel Therapeutics
Phase
Phase 1
Started
2023-01-15
Last updated
2024-10-08

Condition(s) studied

Head and Neck Cancer

Investigational drug(s) / intervention(s)

TumoCure

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.

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: 1. Male and female aged 18-80 years. 2. Subjects who are willing to comply with study procedures. 3. Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent. 4. Subjects with a known diagnosis of primary head and neck cancer, with or without metastases. 5. Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments. 6. Subjects with a measurable tumor by either ultrasound, MRI or CT. 7. Subjects with ECOG performance status of 0 -2. Exclusion Criteria: 1. Subjects with life expectancy of less than 3 months. 2. Pregnant or breastfeeding women. 3. Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV\<50% predicted for age. 4. Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance \< 40 ml/min, calculated by using the Cockroft and Gault formula. 5. Reduced hepatic function, defined as ASAT, ALAT, bilirubin \> 1.5xULN and PK-INR \> 1.5, or a known medical history of liver cirrhosis or portal hypertension. 6. Blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl. 7. Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening. 8. Participation in any other clinical trial that included an investigational device or medicinal product. 9. Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hadassah Medical Center Jerusalem Israel Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05200650 on ClinicalTrials.gov ↗ ← All trials in Israel