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

NCT07891949 | Not Yet Recruiting DMC

• 2 other identifiers: T-BCC-012025-1455-009425
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Nodular BCC

Keywords

Gold nanoparticle; BCC; PPTT

Outcome Measures

Primary Outcomes (10)

• P1. Number of Participants With Treatment-Emergent Adverse Events (Parts 1 and 2)

  Description : Number of participants with at least one treatment-emergent adverse event (TEAE). Severity is graded per CTCAE v5.0 and relationship to TSK-001 and/or NIR irradiation is assessed by the investigator. Results will be reported overall, by maximum severity grade and by relationship category. Unit : participants

  Day 1 (D1) to Day 180

• P2. Number of Participants With Clinically Significant Laboratory Abnormalities (Parts 1 and 2)

  Description : Number of participants with at least one post-baseline haematology or clinical chemistry value judged clinically significant by the investigator. Unit : participants

  from baseline to Day 180

• P3. Number of Participants With Clinically Significant Vital Sign Abnormalities (Parts 1 and 2)

  Description : Number of participants with at least one post-baseline vital sign value (blood pressure, heart rate, body temperature, respiratory rate) judged clinically significant by the investigator. Unit : participants

  baseline to Day 360

• P4. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Parts 1 and 2)

  Description : Number of participants with at least one post-baseline 12-lead ECG finding judged clinically significant by the investigator. Unit : participants

  baseline to Day 360

• P5. Maximum Local Skin Response (LSR) Composite Score (Parts 1 and 2)

  Description : The LSR Grading Scale rates 6 signs at the treated site (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration), each from 0 (absent) to 4 (severe). The composite score is the sum of the 6 grades (range 0-24; higher scores indicate more severe reactions). The highest composite score recorded for each participant over the time frame will be reported. Unit : score on a scale

  Day 1 to Day 360

• P6. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Parts 1 and 2)

  Description : Number of participants with hypopigmentation, hyperpigmentation or scarring at the treated site, as assessed by the investigator. Unit : participants

  Day 1 to Day 360

• P7. Maximum Pain Intensity on a Visual Analogue Scale (Parts 1 and 2)

  Description : Pain at the treated site is self-rated by the participant on a 100 mm VAS (0 mm = no pain, 100 mm = worst imaginable pain). The highest score recorded for each participant will be reported. Unit : mm

  Day 1 to Day 360

• P8. Maximum Lesion Temperature During NIR Irradiation (Parts 1 and 2)

  Description : Highest lesion surface temperature measured by infrared thermography during the irradiation session(s). For participants treated twice (Part 2), the highest value across both sessions will be reported. Unit : °C

  during irradiation on Day 1 (and Day 15 in Part 2)

• P9. Percentage of Participants With Complete Response (Part 3)

  Description : Complete response is defined as disappearance of the target lesion according to RECIST v1.1, measured with digital callipers. Unit : percentage of participants

  Day 29

• P10. Percentage of Participants With No Residual Tumour on Histology (Part 3)

  Description : Absence of residual viable tumour cells on histology of the excised lesion, or of a punch biopsy if no excision is performed. Unit : percentage of participants

  At excision (Day 29 to Day 180) or Day 180

Secondary Outcomes (19)

• S1. Maximum Plasma Gold Concentration (Cmax) (Parts 1 and 2)

  Before injection, 60 min and 24 h after the first injection

• S2. Time to Maximum Plasma Gold Concentration (Tmax) (Parts 1 and 2)

  Before injection, 60 min and 24 h after the first injection

• S3. Area Under the Plasma Gold Concentration-Time Curve From 0 to 24 Hours (AUC0-24h) (Parts 1 and 2)

  Before injection, 60 min and 24 h after the first injection

• S4. Amount of Gold Excreted in Urine (Parts 1 and 2)

  0-24 h and 24-48 h after the first injection

• S5. Gold Concentration in Tumour Tissue (All Parts)

  Day 1 (60 min after injection) and at excision (Day 29 in Part 1, Day 75 in Part 2, Day 29 to Day 180 in Part 3)

Study Arms (5)

Part 1 Cohort 1: TSK-001 10% vol/vol + NIR laser

EXPERIMENTAL

Phase 1 dose escalation (3+3 design, sentinel patient with 29-day DLT observation). Single intratumoural injection of TSK-001 (glucose-functionalised gold nanoparticles, 0.3 mg/mL) at 10% of baseline tumour volume (vol/vol) under topical anaesthesia (EMLAPATCH 5%), followed 1 hour later by near-infrared irradiation of the lesion (808 nm, 1 Watt, continuous wave, 10 minutes). Lesion temperature is monitored by infrared thermography. Tumour excision at Day 29 for histology and gold concentration. 3 to 6 patients.

Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration.; Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)

Part 1 Cohort 2: TSK-001 15% vol/vol + NIR laser

EXPERIMENTAL

Phase 1 dose escalation (3+3 design, sentinel patient with 29-day DLT observation). Single intratumoural injection of TSK-001 (glucose-functionalised gold nanoparticles, 0.3 mg/mL) at 15% of baseline tumour volume (vol/vol) under topical anaesthesia (EMLAPATCH 5%), followed 1 hour later by near-infrared irradiation of the lesion (808 nm, 1 W, continuous wave, 10 minutes). Lesion temperature is monitored by infrared thermography. Tumour excision at Day 29 for histology and gold concentration. 3 to 6 patients.

Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration.; Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)

Part 1 Cohort 3: TSK-001 20% vol/vol + NIR laser

EXPERIMENTAL

Phase 1 dose escalation (3+3 design, sentinel patient with 29-day DLT observation). Single intratumoural injection of TSK-001 (glucose-functionalised gold nanoparticles, 0.3 mg/mL) at 20% of baseline tumour volume (vol/vol) under topical anaesthesia (EMLAPATCH 5%), followed 1 hour later by near-infrared irradiation of the lesion (808 nm, 1 W, continuous wave, 10 minutes). Lesion temperature is monitored by infrared thermography. Tumour excision at Day 29 for histology and gold concentration. 3 to 6 patients.

Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration.; Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)

Part 2: TSK-001 ×2 (14 days apart) at MTD/MAD + NIR

EXPERIMENTAL

Phase 1 expansion cohort to identify the recommended Phase 2 dose (RP2D). Two intratumoural injections of TSK-001 at the maximum tolerated dose (MTD) or maximum administered dose (MAD) determined in Part 1, given on Day 1 and Day 15, under topical anaesthesia (EMLAPATCH 5%). Each injection is followed 1 hour later by near-infrared irradiation (808 nm, 1 W, continuous wave, 10 minutes) with infrared monitoring of lesion temperature. Tumour excision at Day 75 for histology and gold concentration. 6 patients, up to 12 if de-escalation is required.

Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration.; Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)

Part 3: TSK-001 ×2 (14 days apart) at RP2D + NIR

EXPERIMENTAL

Phase 2 extension in patients with low-risk nodular BCC in non-operable or surgically complex areas. Two intratumoural injections of TSK-001 at the RP2D identified in Part 2, given on Day 1 and Day 15, under local anaesthesia (lidocaine 1%). Each injection is followed 1 hour later by near-infrared irradiation (808 nm, 1 W, continuous wave, 10 minutes) with infrared monitoring of lesion temperature. Complete response assessed per RECIST v1.1 at Day 29. Excision at investigator discretion between Day 29 and Day 180, or punch biopsy at Day 180. Scar assessment with SBSES and POSAS. Up to 42 patients.

Device: TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration.; Device: 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)

Interventions

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

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.

Part 1 Cohort 1: TSK-001 10% vol/vol + NIR laser; Part 1 Cohort 2: TSK-001 15% vol/vol + NIR laser; Part 1 Cohort 3: TSK-001 20% vol/vol + NIR laser; Part 2: TSK-001 ×2 (14 days apart) at MTD/MAD + NIR; Part 3: TSK-001 ×2 (14 days apart) at RP2D + NIR

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

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.

Part 1 Cohort 1: TSK-001 10% vol/vol + NIR laser; Part 1 Cohort 2: TSK-001 15% vol/vol + NIR laser; Part 1 Cohort 3: TSK-001 20% vol/vol + NIR laser; Part 2: TSK-001 ×2 (14 days apart) at MTD/MAD + NIR; Part 3: TSK-001 ×2 (14 days apart) at RP2D + NIR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Member of the study staff, or immediate family or household member of study staff
• Person under guardianship or other legal protection measure
• Currently incarcerated

Sponsors & Collaborators

• Torskal SAS: lead

Study Sites (1)

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

Wellington, 6021, New Zealand

Location

Related Publications (1)

• Pesnel S, Ben Haddada M, Duquenne S, Mortier L, Bertolotti A, Perrot JL, Morel AL. Plasmonic nanophotothermal therapy for the treatment of basal cell carcinoma with gold nanoparticles. JEADV Clin Pract. 2024;3(2):448-456. doi:10.1002/jvc2.301 Pesnel S, Bertolotti A, Duquenne S, et al. Plasmonic nanophotothermal therapy: Destruction of 500 mm³ subcutaneous human basal cell carcinoma with gold nanoparticles and near infrared laser. Skin Res Technol. 2024;30:e13890. Ben Haddada M, Koshel D, Yang Z, et al. Proof of concept of plasmonic thermal destruction of surface cancers by gold nanoparticles obtained by green chemistry. Colloids Surf B Biointerfaces. 2019;184:110496. doi:10.1016/j.colsurfb.2019.110496

  BACKGROUND

MeSH Terms

Interventions

Hydrotherapy; Injections; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Therapeutics; Rehabilitation; Drug Administration Routes; Drug Therapy; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Karen Oldfield, Dr

  Medical Research Institute of New Zealand (MRINZ)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Jones

CONTACT

+64223553088; Julie.Jones@aptclinicaltrials.com

Anne-Laure Morel, PhD

CONTACT

+2620692720292; annelaure.morel@torskal.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2026
• First Posted: October 23, 2026
• Study Start: October 1, 2026
• Primary Completion: October 1, 2026
• Study Completion (Estimated): June 1, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)