Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07891949

Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)

Sponsor: Torskal SAS

View on ClinicalTrials.gov

Summary

Investigational Device * TSK-001 injectable glucose-functionalised gold nanoparticle solution for intratumoural administration (0.3 mg nanoparticles in 1mL water for injection) * Laser device 808 nm Dose regimen TSK-001 * Part 1: Single intratumoural injection at 10%, 15%, and 20% of the tumour volume (vol/vol). * Part 2: Two intratumoural injections at the maximum tolerated dose (MTD) or maximum administered dose (MAD) administered two weeks apart. * Part 3: Two injections of TSK-001 at the Recommended Phase 2 Dose (RP2D) administered 2 weeks apart. Laser Device Near-infra red (NIR) irradiation of the tumour will be performed 1 hour after each injection of TSK-001 at the following laser settings: * Wavelength: 808 nm * Power density: 1 Watt Mode: Continuous wave * Duration: 10 minutes Comparator N/A Treatment Groups Part 1: Part 1 consists of 3 single dose escalation cohorts: * Cohort 1: TSK-001 10% vol/vol * Cohort 2: TSK-001 15% vol/vol * Cohort 3: TSK-001 20% vol/vol Part 2: Part 2 consists of a multiple dose expansion cohort who will receive two injections of TSK-001 at the MAD or MTD administered 2 weeks apart. Part 3: Part 3 consists of a Phase 2 multiple dose cohort who will receive two injections of TSK-001 at the RP2D administered 2 weeks apart. Objectives Primary Objectives Part 1 To assess the safety and tolerability of a single administration of TSK001 combined with NIR irradiation in patients with nodular Basal Cell Carcinoma (nBCC). Part 2 To assess the safety and tolerability of two administrations of TSK-001 combined with NIR irradiation in patients with nBCC. Part 3 To assess Complete Response (CR) (disappearance of cutaneous tumour) of the target lesion using RECIST v1.1 criteria following two administrations of TSK-001 combined with NIR irradiation in patients with nBCC. Secondary Objectives Part 1 * To assess the pharmacokinetics (PK) of TSK-001 in plasma and urine, and gold concentration in tumour following a single administration of TSK-001 combined with NIR irradiation in patients with nBCC. * To assess Complete Response (CR) (disappearance of cutaneous tumour) of the target lesion using RECIST v1.1 criteria following single administration of TSK-001 combined with NIR irradiation in patients with nBCC. * To assess complete clinical and imaging clearance through photography and lack of diagnostic structures on dermoscopy Part2 * To assess the pharmacokinetics (PK) of TSK-001 in plasma and urine, and gold concentration in tumour following two treatments (14 days apart) of TSK-001 combined with NIR irradiation in patients with nBCC. * To assess Complete Response (CR) (disappearance of cutaneous tumour) of the target lesion using RECIST v1.1 criteria following two administrations of TSK-001 combined with NIR irradiation in patients with nBCC. * To assess complete clinical and imaging clearance through photography and lack of diagnostic structures on dermoscopy. Part 3: * To assess complete clinical and imaging clearance through photography and lack of diagnostic structures on dermoscopy. * To assess the scar healing effect of TSK-001 combined with NIR irradiation in patients with BCC. * To assess the safety and tolerability of two administrations of TSK001 combined with NIR irradiation in patients with nBCC. * To assess the gold concentration in tumour following two administrations of TSK-001 combined with NIR irradiation in patients with nBCC. Endpoints Primary endpoints Parts 1 and 2 * Incidence, severity, and relationship of adverse events (AEs). * Changes from baseline in clinical laboratory parameters, vital signs, and 12-lead ECG. * Incidence, frequency and severity of local skin reactions (LSRs), pigmentation and scarring using the LSR Grading Scale. * Pain using a 100 mm Visual Analogic Scale (VAS) * Lesion temperature measured by infrared thermography Part 3: * CR, defined as the disappearance of the target tumour lesion according to RECIST v1.1 at Day 29. * Histology of excised residual tumour from Day 29 to Day 180. * Histology of tumour in punch biopsy at Day 180 at the latest for observation of any residual viable tumour cells after treatment. Secondary endpoints Part 1 * Plasma and urine PK parameters * Presence of gold nanoparticles in excised residual tumour at Day 29. * CR, defined as the disappearance of the target tumour lesion according to RECIST v1.1 at Day 29

Official title: Phase 1/2 Dose-Escalation and Expansion Study to Determine Safety, Tolerability and Efficacy of TSK-001 Plasmonic Photothermal Therapy in Patients With Nodular Basal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-10

Completion Date

2030-06

Last Updated

2026-10-23

Healthy Volunteers

Conditions

Nodular BCC

Interventions

DEVICE

TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration.

Investigational class III medical device: sterile, ready-to-use dispersion of glucose-coated plasmonic gold nanoparticles (0.3 mg/mL) in water for injection, without excipients, supplied in 2 mL glass vials. Administered by slow intratumoural injection (20G needle, 0.5 or 1 mL precision syringe; microinjections to avoid pocketing). The injected volume is proportional to baseline tumour volume measured by digital calliper (length × width × depth): 10%, 15% or 20% vol/vol in Part 1, MTD/MAD in Part 2, RP2D in Part 3. Single injection on Day 1 (Part 1) or two injections on Day 1 and Day 15 (Parts 2 and 3). The nanoparticles are biologically inert until activated by 808 nm near-infrared light, which they convert into localised heat.

DEVICE

808 nm near-infrared (NIR) diode laser (Hyper Diode 808)

Commercially available class IIb diode laser (Hyper Diode 808, Hyper Photonics S.r.l., Italy), used outside its labelled indications as the activation source for TSK-001. One hour after each TSK-001 injection, the target lesion is irradiated at 808 nm, 1 Watt, continuous wave, for 10 minutes. These settings are well below those used in routine dermatological applications (12-25 W) and are non-ablative in the absence of TSK-001. Lesion temperature is monitored by infrared thermography, with a target therapeutic window of 42-45 °C; a lesion temperature above 45 °C is a protocol stopping rule.

Inclusion Criteria: * Male or female aged 18 years or over at the time of consent, willing and able to provide written informed consent prior to any study-related procedure * Body weight ≥ 50 kg * Histologically confirmed cutaneous nodular basal cell carcinoma (nBCC) located on the trunk, extremities (arms, legs) or non-critical facial areas (cheeks, forehead, temples, scalp, neck or chin) * Part 3 only: nBCC located in a low-risk, non-operable or surgically complex area within the locations listed above * Measurable lesion as per Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1) * Maximum tumour volume of 2 cm³; only one lesion per patient will be treated * Tumour treatable by surface light illumination * Haematology, hepatic function (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], alkaline phosphatase \[ALP\], gamma-glutamyl transferase \[GGT\], lactate dehydrogenase \[LDH\], total, indirect and direct bilirubin) and renal function (urea, creatinine, phosphorus, uric acid, estimated glomerular filtration rate \[eGFR\] calculated with the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] equation) within normal limits; out-of-range values may be accepted at the Investigator's discretion if not clinically significant * Fitzpatrick skin phototype I to III * No clinically significant abnormality on 12-lead electrocardiogram (ECG) * Women of childbearing potential: negative pregnancy test at screening and before treatment on Day 1, and use of highly effective contraception from screening until at least 6 months + 4 days after the last study treatment (postmenopausal is defined as at least 12 months without menstruation with no alternative explanation) * Men: use of condoms during treatment and until at least 3 months + 4 days after the last study treatment * Willing and able to attend all scheduled visits and, in the Investigator's opinion, able to understand and comply with study procedures Exclusion Criteria: * Tumour on the eyelid or closely surrounding the eye * Tumour deeper than 0.5 cm that cannot be reached by near-infrared (NIR) irradiation * Prior photodynamic therapy or other local therapy to the lesion to be treated * History or clinical evidence of any surgical or medical condition that, in the judgement of the Investigator and/or medical monitor, is likely to interfere with the study results or pose an additional risk (e.g. rapidly progressive or uncontrolled disease of a major organ system, immunodeficiency, or clinically significant active psychiatric disorder or history of substance abuse disorder) * Pregnant or breastfeeding, or planning to become pregnant during the study * Current therapeutic oral anticoagulation (aspirin for a thromboembolic event is allowed; low molecular weight heparin is allowed if it is medically acceptable to interrupt it for the TSK-001 procedure) * Known or suspected hypersensitivity or severe allergic reaction (including anaphylaxis, generalised urticaria, angioedema) to any constituent of TSK-001 or to NIR irradiation * Hypersensitivity to lidocaine, prilocaine or other amide-type local anaesthetics, or to any of their excipients * Current smoker, or stopped smoking less than 1 year ago * Drug or alcohol abuse or dependence within 12 months before screening * Within the exclusion period of a previous clinical study according to applicable regulations * Member of the study staff, or immediate family or household member of study staff * Person under guardianship or other legal protection measure * Currently incarcerated

Locations (1)

Medical Research Institute of New Zealand (MRINZ), Level 7, CSB Building, Wellington Hospital, Riddiford Street, Newtown, Wellington, 6021, New Zealand

Wellington, New Zealand