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OncoMatch/Clinical Trials/NCT05200650

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

Is NCT05200650 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TumoCure for head and neck cancer.

Phase 1RecruitingIntraGel TherapeuticsNCT05200650Data as of May 2026

Treatment: TumoCureIntraGel'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

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Extracted eligibility criteria

Cancer type

Head and Neck Squamous Cell Carcinoma

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Cannot have received: systemic chemotherapy

Subject who was treated with systemic chemotherapy during the 4 weeks preceding screening.

Lab requirements

Blood counts

blood leukocytes count <1.5 *103/microl or platelets <75 *103/microl [excluded]

Kidney function

s-creatinine ≥ 1.5xuln or creatinine clearance < 40 ml/min [excluded]

Liver function

asat, alat, bilirubin > 1.5xuln and pk-inr > 1.5, or a known medical history of liver cirrhosis or portal hypertension [excluded]

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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