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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

Primary Purpose

Head and Neck Cancer

Status

Recruiting

Phase

Phase 1

Locations

Israel

Study Type

Interventional

Intervention

TumoCure

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Hadassah Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TumoCure Treatment

Arm Description

Subjects will be treated with a single intra-tumor injection of TumoCure, containing the polymeric delivery system and the Cisplatin hemotherapy agent at a dose of 100mg.

Outcomes

Primary Outcome Measures

Rate of Serious Adverse Events

Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days)

Secondary Outcome Measures

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

Full Information

NCT ID

NCT05200650

First Posted

December 30, 2021

Last Updated

March 6, 2023

Sponsor

IntraGel Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05200650

Brief 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

Official Title

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 15, 2023 (Actual)

Primary Completion Date

November 15, 2023 (Anticipated)

Study Completion Date

June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

IntraGel Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head and Neck Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

TumoCure Treatment

Arm Type

Experimental

Arm Description

Subjects will be treated with a single intra-tumor injection of TumoCure, containing the polymeric delivery system and the Cisplatin hemotherapy agent at a dose of 100mg.

Intervention Type

Combination Product

Intervention Name(s)

TumoCure

Intervention Description

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.

Primary Outcome Measure Information:

Title

Rate of Serious Adverse Events

Description

Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days)

Time Frame

90 days

Secondary Outcome Measure Information:

Title

Change in Tumor Size (Efficacy)

Description

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

Time Frame

90 days

Other Pre-specified Outcome Measures:

Title

Overall Survival

Description

Overall survival (OS) throughout the follow up period (90 days)

Time Frame

90 days

Title

Subject Quality of Life

Description

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.

Time Frame

90 days

Title

Subject Quality of Life

Description

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.

Time Frame

90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maya Shick

Phone

972523355442

mayashick@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aharon Popovizer, MD

Organizational Affiliation

Head of Head and Neck Surgery Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah Medical Center

City

Jerusalem

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Orit Cohen

ORITCOHEN@hadassah.org.il

First Name & Middle Initial & Last Name & Degree

Aharon Popovitzer, MD

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD is not planned to be shared

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