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

Last updated: October 3, 2024
Sponsor: IntraGel Therapeutics
Overall Status: Active - Recruiting

Phase

1

Condition

Head And Neck Cancer

Human Papilloma Virus (Hpv)

Nasopharyngeal Cancer

Treatment

TumoCure

Clinical Study ID

NCT05200650
CLPR-001
  • Ages 18-80
  • All Genders

Study 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

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 ofunderstanding and signing the informed consent.

  4. Subjects with a known diagnosis of primary head and neck cancer, with or withoutmetastases.

  5. Subjects with a progressing or radio-resistant disease, who are unable, unwilling ordo 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

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 indicatinga 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 precedingscreening.

  8. Participation in any other clinical trial that included an investigational device ormedicinal product.

  9. Any other condition that according to the discretion of the primary investigatorprecludes the subject from participating in the study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: TumoCure
Phase: 1
Study Start date:
January 15, 2023
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • Hadassah Medical Center

    Jerusalem,
    Israel

    Active - Recruiting

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