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

NCT05200650 | Recruiting Phase 1

• 1 other identifier: CLPR-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Rate of Serious Adverse Events

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

  90 days

Secondary Outcomes (1)

• Change in Tumor Size (Efficacy)

  90 days

Other Outcomes (3)

• Overall Survival

  90 days

• Subject Quality of Life

  90 days

• Subject Quality of Life

  90 days

Study Arms (1)

TumoCure Treatment

EXPERIMENTAL

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.

Combination Product: TumoCure

Interventions

TumoCure COMBINATION_PRODUCT

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.

TumoCure Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IntraGel Therapeutics: lead

Study Sites (1)

Hadassah Medical Center

Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Aharon Popovizer, MD

  Head of Head and Neck Surgery Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maya Shick

CONTACT

972523355442; mayashick@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2021
• First Posted: January 21, 2022
• Study Start: January 15, 2023
• Primary Completion: May 15, 2025
• Study Completion: July 1, 2025
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)