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

Brief 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