NCT05200650 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
| NCT ID | NCT05200650 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | IntraGel Therapeutics |
| Condition | Head and Neck Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-01-15 |
| Primary Completion | 2025-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-01-15 with a primary completion date of 2025-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 available treatment options, either due to inefficacy, intolerability or inapplicability of standard treatment
Eligibility Criteria
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.
Contact & Investigator
Aharon Popovizer, MD
PRINCIPAL INVESTIGATOR
Head of Head and Neck Surgery Department
Frequently Asked Questions
Who can join the NCT05200650 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Head and Neck Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05200650 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05200650 currently recruiting?
Yes, NCT05200650 is actively recruiting participants. Contact the research team at mayashick@gmail.com for enrollment information.
Where is the NCT05200650 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT05200650 clinical trial?
NCT05200650 is sponsored by IntraGel Therapeutics. The principal investigator is Aharon Popovizer, MD at Head of Head and Neck Surgery Department. The trial plans to enroll 20 participants.
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