Status:
RECRUITING
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
Lead Sponsor:
IntraGel Therapeutics
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 av...
Eligibility Criteria
Inclusion
- Male and female aged 18-80 years.
- Subjects who are willing to comply with study procedures.
- Subjects who are mentally and cognitively capable and who are capable of understanding and signing the informed consent.
- Subjects with a known diagnosis of primary head and neck cancer, with or without metastases.
- Subjects with a progressing or radio-resistant disease, who are unable, unwilling or do not tolerate currently available treatments.
- Subjects with a measurable tumor by either ultrasound, MRI or CT.
- Subjects with ECOG performance status of 0 -2.
Exclusion
- Subjects with life expectancy of less than 3 months.
- Pregnant or breastfeeding women.
- Known COPD or other chronic pulmonary or respiratory disease, with PFT's indicating a FEV\<50% predicted for age.
- Known reduced renal function, defined S-Creatinine ≥ 1.5xULN or Creatinine clearance \< 40 ml/min, calculated by using the Cockroft and Gault formula.
- 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.
- Blood leukocytes count \<1.5 \*103/microl or platelets \<75 \*103/microl.
- Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening.
- Participation in any other clinical trial that included an investigational device or medicinal product.
- Any other condition that according to the discretion of the primary investigator precludes the subject from participating in the study.
Key Trial Info
Start Date :
January 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05200650
Start Date
January 15 2023
End Date
July 1 2025
Last Update
October 8 2024
Active Locations (1)
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1
Hadassah Medical Center
Jerusalem, Israel