Injectable gel treatment for advanced head and neck cancer

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

This study is testing a new injectable gel treatment for patients with advanced head and neck cancer who have run out of other options to see if it can help them.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: IntraGel Therapeutics (industry)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jerusalem)
• Trial ID: NCT05200650 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety, tolerability, and initial efficacy of TumoCure, a polymer-based gel loaded with Cisplatin, administered via a single intra-tumoral injection. It targets patients with progressive or radio-resistant primary head and neck tumors who have no other treatment options available. The study is open-label and conducted across multiple centers, focusing on patients who can tolerate the treatment and have measurable tumors. The goal is to provide a localized chemotherapy option for those who have exhausted standard treatments.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-80 with progressive or radio-resistant primary head and neck cancer and measurable tumors.

Not a fit: Patients with a life expectancy of less than 3 months or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new localized chemotherapy option for patients with limited treatment choices.

How similar studies have performed: While this approach is novel, similar localized chemotherapy methods have shown promise in other cancer types, suggesting potential for success.

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.

Where this trial is running

Jerusalem

• Hadassah Medical Center — Jerusalem, Israel (RECRUITING)

Study contacts

• Principal investigator: Aharon Popovizer, MD — Head of Head and Neck Surgery Department
• Study coordinator: Maya Shick

Conditions: Head and Neck Cancer