Recent Updates
Recently added Catalysts

TumoCure

Phase 1

Head and Neck Cancer | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Oct 8, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment20

FDA Designations

No designations recorded

Clinical trial landscape

TumoCure · 1 trial · 1 indication

Phase 1 1
NCT05200650A 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 TumorHead and Neck Cancer
RECRUITING20 Analytics
PHASE1RECRUITING
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 CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of Serious Adverse Events
90 days

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

Secondary Endpoints

Change in Tumor Size (Efficacy)
90 days
Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TumoCure TreatmentEXPERIMENTALSubjects 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.

Interventions

NameTypeDescription
TumoCureCOMBINATION_PRODUCTTumoCure 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.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 ne...

Countries:Israel
Unlock Eligibility Criteria

Frequently asked questions about TumoCure

What is TumoCure used for?

TumoCure is an investigational small molecule being developed for head and neck cancer. It is currently in a Phase 1 clinical trial for patients with progressive or radio-resistant primary head and neck tumors. The drug is administered as a single intra-tumoral injection and is being studied for safety, tolerability, and initial efficacy.

What does TumoCure target?

TumoCure is a polymer-based cisplatin-loaded gel. It delivers cisplatin, a chemotherapy agent, directly into the tumor through an intra-tumoral injection. The gel formulation is designed to allow localized delivery of the drug to the tumor site.

Who makes TumoCure?

TumoCure is being developed by cbdMD, Inc., a company traded under the ticker YCBD. The drug is currently in Phase 1 clinical development for head and neck cancer.

What phase is TumoCure in?

TumoCure is in Phase 1 clinical development. It is currently being evaluated in a Phase 1b study that is recruiting participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is TumoCure in?

TumoCure is being studied in a single clinical trial with the identifier NCT05200650. This is a Phase 1b, single-arm, open-label, multi-center study in Israel. The trial is recruiting 20 participants with progressive or radio-resistant primary head and neck tumors.

Is TumoCure the same as IntraGel's cisplatin-loaded gel?

Yes, TumoCure is the same as IntraGel's polymer-based cisplatin-loaded gel. The clinical trial NCT05200650 refers to the drug as TumoCure and describes it as IntraGel's polymer-based cisplatin-loaded gel.