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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05200650
• Other study ID #: CLPR-001
• Status: Recruiting
• Phase: Phase 1
• Start date: January 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: March 2023
• Source: IntraGel Therapeutics
• Contact: Maya Shick
• Phone: 972523355442
• Email: mayashick[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 1, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Israel	Hadassah Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
IntraGel Therapeutics

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Survival	Overall survival (OS) throughout the follow up period (90 days)	90 days
Other	Subject Quality of Life	Subject Quality of Life (QoL), as determined by the change in EORTC-QLQ30 (European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - 30) total score (ranging from 30-120, the lower the result, the better quality of life the subject reports) from baseline to end of follow up period.	90 days
Other	Subject Quality of Life	EORTC-QLQ HNC43 (European Organization for Research and Treatment of Cancer - Quality of Life Head and Neck Questionnaire 43) questionnaire total score (ranging from 43-172, the lower the result the better quality of life the subject reports) from baseline to end of follow up period.	90 days
Primary	Rate of Serious Adverse Events	Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days)	90 days
Secondary	Change in Tumor Size (Efficacy)	change in tumor size from baseline to the end of the follow up period (90 days) according to the RECIST methodology, as determined by MRI/CT imaging	90 days