Head and Neck CancerPhase 1NCT05200650
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
A Phase 1 study testing TumoCure in people with Head and Neck Cancer, run by IntraGel Therapeutics at 1 site in Israel.
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- TumoCure
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Jan 2023to 1 Jul 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Hadassah Medical Center
Jerusalem
Orit Cohen, ORITCOHEN@hadassah.org.il
Aharon Popovitzer, MD
About this study
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
- Being tested
- TumoCure
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TumoCureCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: TumoCure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Serious Adverse Events
Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days)
Measured: 90 days
Secondary outcomes (1)
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start15 Jan 2023
- Primary completion15 May 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IntraGel Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aharon Popovizer, MD, Principal investigator, Head of Head and Neck Surgery Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05200650
- Sponsor's protocol ID
- CLPR-001
- Status last verified
- Oct 2024
- First submitted
- 30 Dec 2021
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD is not planned to be shared
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05200650
- Acronym / sponsor ID
- CLPR-001
- Conditions
- Head and Neck Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- IntraGel TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 15 May 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TumoCure Treatment | Experimental | Combination Product: TumoCureSubjects 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TumoCureTumoCure 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. | Combination product | TumoCure Treatment |
Primary outcome
Rate of Serious Adverse Events
Time frame: 90 days
Cumulative rate of treatment - related serious adverse events (SAEs) throughout the follow up period (90 days)
1 secondary outcome
Change in Tumor Size (Efficacy)
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Individual participant dataSharing planned: No. IPD is not planned to be shared
Related trials for Head and Neck Cancer
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Not yet recruitingObservational study
Serum Treg/Th17-Related Cytokines and Systemic Inflammatory Indices in Differentiated Thyroid Cancer
Differentiated Thyroid Cancer (DTC), Papillary Thyroid Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aharon Popovizer, MD principal investigator
Head of Head and Neck Surgery Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TumoCure in people with Head and Neck Cancer, run by IntraGel Therapeutics at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maya Shick (972523355442, mayashick@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Serious Adverse Events (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.