Nodular BCCNCT07891949
Plasmonic PhotoThermal Therapy (PPTT) With Glucose-Coated Gold Nanoparticles (TSK-001) in Patients With Nodular Basal Cell Carcinoma (nBCC)
A study testing TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. and 808 nm near-infrared (NIR) diode laser (Hyper Diode 808) in people with Nodular BCC, run by Torskal SAS at 1 site in New Zealand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nodular BCC
- What is being tested?
- TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. and 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteNew Zealand
- Study dates
- Oct 2026to Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
New Zealand1 site
Medical Research Institute of New Zealand (MRINZ), Level 7, CSB Building, Wellington Hospital, Riddiford Street, Newtown, Wellington, 6021, New Zealand
Wellington, 6021
Karen Oldfield, Dr, +64 04 805 0235 ext. +64, Karen.oldfield@mrinz.ac.nz
Jonathan Barrett, jonathan.barrett@mrinz.ac.nz
About this study
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
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
Read more
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
Read the detailed description
This is an open-label, multicentre, first-in-human, dose-escalation and expansion study designed to evaluate the safety, tolerability and performance of TSK-001 (glucose-coated plasmonic gold nanoparticles) used in combination with near-infrared (NIR) laser irradiation in adult men and women with nodular basal cell carcinoma (nBCC). A maximum of 78 patients is planned to be enrolled.
The study is divided into three parts.
Part 1 - Dose escalation
Part 1 consists of 3 dose-escalation cohorts designed to determine the maximum tolerated dose (MTD) or, if not reached, the maximum administered dose (MAD). Patients receive a single intratumoural injection of TSK-001, followed 1 hour later by NIR irradiation of the tumour. Three dose levels, expressed as a percentage of the tumour volume (volume/volume, vol/vol), will be evaluated:
- Cohort 1: TSK-001 10% vol/vol
- Cohort 2: TSK-001 15% vol/vol
- Cohort 3: TSK-001 20% vol/vol Up to 6 patients will be enrolled per cohort (maximum 18 patients in total). Dose escalation is achieved by increasing the injected volume of TSK-001 and follows the standard oncology 3+3 design. The Data Monitoring Committee (DMC) may also recruit additional patients at the current dose level. A Safety Review Committee (SRC) is responsible for decisions to escalate or de-escalate doses.
Three patients are allocated to each new dose level. Each dose level starts with a sentinel patient; if no dose-limiting toxicity (DLT) is observed during a 29-day observation period, the remaining 2 patients may be enrolled in parallel. If a DLT is observed in 1 of 3 patients, 3 additional patients are enrolled at the same dose level. If 2 or more patients experience a DLT at a given dose level, recruitment into that cohort is stopped and the dose is de-escalated until a dose level is reached at which no more than 1 of 6 patients has a DLT; this dose level is defined as the MTD. If no further DLTs are observed, escalation continues to the next dose level. Intermediate dose levels may be introduced to ensure patient safety and better define the MTD. If no more than 1 DLT is observed at the highest dose (20% vol/vol), 3 additional patients are treated at that level; if no more than 1 of these 6 patients has a DLT, this dose is defined as the MAD.
Part 2 - Dose expansion Part 2 starts once the MTD or MAD has been determined and aims to identify the recommended Phase 2 dose (RP2D). Patients receive 2 intratumoural injections of TSK-001 at the MTD or MAD, 2 weeks apart, each followed 1 hour later by NIR irradiation. Six patients will be enrolled initially (maximum 12). If 2 or more patients experience a DLT, recruitment is stopped and the dose may be de-escalated in 6 new patients. If no more than 1 patient experiences a DLT, the study proceeds to Part 3 at the tested dose. The SRC reviews safety data throughout the study and is responsible for de-escalation decisions.
Part 3 - Phase 2 extension Up to 42 patients with nBCC will receive 2 intratumoural injections of TSK-001 at the RP2D identified in Part 2, 2 weeks apart, each followed 1 hour later by NIR irradiation. If 2 or more patients experience a DLT, recruitment will be stopped and a lower dose may be considered.
Lesion temperature monitoring Lesion temperature is monitored with an infrared thermography device during irradiation. The target therapeutic temperature range is 42-45 °C.
Pharmacokinetic (PK) sub-study A total of 12 patients from Parts 1 and 2 (3 per Part 1 cohort and 3 in Part 2) will take part in the PK sub-study. Blood samples will be collected before treatment, 60 minutes after the first injection on Day 1, and 24 hours after the first injection (Day 2). Urine will be collected 0-24 hours and 24-48 hours after the first injection.
Statistical analysis A detailed Statistical Analysis Plan (SAP) will be finalised before the first patient's visit. Safety endpoints will be analysed descriptively and presented by study part and dose group. Continuous variables will be summarised by number of non-missing values, mean, standard deviation (SD), median, minimum and maximum; categorical variables by frequency counts and percentages. Where required, two-sided 95% confidence intervals (CIs) will be calculated and significance testing will use a two-sided 5% significance level. Missing data will not be imputed.
Analysis sets:
- Full Analysis Set (FAS): all enrolled participants; used for participant disposition, baseline demographics, protocol deviations and efficacy data.
- Safety Set: all participants who received at least one dose of TSK-001; used for all safety data.
- PK Set: all participants who received at least one dose of TSK-001 and have at least one PK concentration value.
Sample size:
- Parts 1 and 2: as this is a first-in-human study, no formal sample size calculation was performed. Up to 18 patients will be enrolled in Part 1 (3+3 design across 3 dose levels) and up to 12 patients in Part 2.
- Part 3: assuming a complete response (CR) rate of 95%, 35 evaluable patients will provide a two-sided 95% CI for the CR rate of approximately 80% to 100%. Allowing for a 20% dropout rate, 42 patients will be enrolled.
- Conditions
- Nodular BCC
- Being tested
- TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration., 808 nm near-infrared (NIR) diode laser (Hyper Diode 808)
- Keywords
- Gold nanoparticle, BCC, PPTT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At excision (Day 29 to Day 180) or Day 180
Secondary outcomes (19)
S1. Maximum Plasma Gold Concentration (Cmax) (Parts 1 and 2)
Description : Cmax of gold in plasma after the first TSK-001 injection, in the PK subset (3 participants per Part 1 cohort and 3 in Part 2).
Unit : ng/mL
Measured: Before injection, 60 min and 24 h after the first injection
S2. Time to Maximum Plasma Gold Concentration (Tmax) (Parts 1 and 2)
Description : Tmax after the first TSK-001 injection, in the PK subset.
Unit : hours
Measured: 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)
Description : AUC0-24h calculated by non-compartmental analysis, in the PK subset.
Unit : ng·h/mL
Measured: Before injection, 60 min and 24 h after the first injection
S4. Amount of Gold Excreted in Urine (Parts 1 and 2)
Description : Amount of gold excreted in urine over each collection interval, in the PK subset.
Unit : µg
Measured: 0-24 h and 24-48 h after the first injection
S5. Gold Concentration in Tumour Tissue (All Parts)
Description : Gold concentration in tumour tissue measured by ICP-MS, from the punch biopsy and from the excised lesion.
Unit : µg/g of tissue
Measured: 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)
S6. Percentage of Participants With Complete Response (Parts 1 and 2)
Description : Disappearance of the target lesion according to RECIST v1.1.
Unit : percentage of participants
Measured: Day 29
S7. Percentage of Participants With Complete Clinical and Dermoscopic Clearance (All Parts)
Description : A participant is counted as cleared only if both conditions are met: no clinically visible tumour on standardised photography AND no BCC diagnostic structures on dermoscopy.
Unit : percentage of participants
Measured: Day 29
S8. Percentage of Participants With Histological Clearance (Parts 1 and 2)
Description : No residual viable tumour cells on histology of the excised lesion (punch biopsy for non-operable or surgically complex areas).
Unit : percentage of participants
Measured: Day 29 (Part 1) and Day 75 (Part 2)
S9. Stony Brook Scar Evaluation Scale (SBSES) Total Score (Part 3)
Description : Investigator-rated scar assessment, total score ranging from 0 (worst) to 5 (best).
Unit : score on a scale
Measured: Days 15, 29, 43, 90 and 180
S10. Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale Total Score (Part 3)
Description : Six items each rated 1-10. The total score ranges from 6 to 60; higher scores indicate worse scar quality.
Unit : score on a scale
Measured: Days 15, 29, 43, 90 and 180
S11. POSAS - Observer Scale Total Score (Part 3)
Description : Six items each rated 1-10. The total score ranges from 6 to 60; higher scores indicate worse scar quality.
Unit : score on a scale
Measured: Days 15, 29, 43, 90 and 180
S12. Number of Participants With Treatment-Emergent Adverse Events (Part 3)
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
Measured: Day 1 to Day 360
S13. Number of Participants With Clinically Significant Laboratory Abnormalities (Part 3)
Description : Number of participants with at least one post-baseline haematology or clinical chemistry value judged clinically significant by the investigator.
Unit : participants
Measured: Baseline to Day 360
S14. Number of Participants With Clinically Significant Vital Sign Abnormalities (Part 3)
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
Measured: baseline to Day 360
S15. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Part 3)
Description : Number of participants with at least one post-baseline 12-lead ECG finding judged clinically significant by the investigator.
Unit : participants
Measured: Baseline to Day 360
S16. Maximum Local Skin Response (LSR) Composite Score (Part 3)
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
Measured: Day 1 to Day 360
S17. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Part 3)
Description : Number of participants with hypopigmentation, hyperpigmentation or scarring at the treated site, as assessed by the investigator.
Unit : participants
Measured: Day 1 to Day 360
S18. Maximum Pain Intensity on a Visual Analogue Scale (Part 3)
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
Measured: Day 1 to Day 360
S19. Maximum Lesion Temperature During NIR Irradiation (Part 3)
Description : Highest lesion surface temperature measured by infrared thermography during the irradiation session(s).
For participants treated twice (Part 3), the highest value across both sessions will be reported.
Unit : °C
Measured: During irradiation on Day 1 and Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nodular BCCStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Torskal SAS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Oldfield, Dr, Principal investigator, Medical Research Institute of New Zealand (MRINZ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891949
- Sponsor's protocol ID
- T-BCC-01
- Other IDs
- 2025-1455-009425
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. This is a small first-in-human study (up to 78 participants) that includes standardised clinical photographs of skin lesions, some on the face, which carry a high risk of re-identification even after pseudonymisation. Data are processed under the EU General Data Protection Regulation, and the informed consent does not cover sharing of individual data with third parties. Aggregate results will be made publicly available through the EU medical device database (EUDAMED) in accordance with Regulation (EU) 2017/745, posted on this registry, and submitted for publication in a peer-reviewed journal.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07891949
- Acronym / sponsor ID
- T-BCC-01
- Conditions
- Nodular BCC
- Keywords
- Gold nanoparticle, BCC, PPTT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Torskal SASUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is an open-label, multicentre, first-in-human, dose-escalation and expansion study designed to evaluate the safety, tolerability and performance of TSK-001 (glucose-coated plasmonic gold nanoparticles) used in combination with near-infrared (NIR) laser irradiation in adult men and women with nodular basal cell carcinoma (nBCC). A maximum of 78 patients is planned to be enrolled.
The study is divided into three parts.
Part 1 - Dose escalation
Part 1 consists of 3 dose-escalation cohorts designed to determine the maximum tolerated dose (MTD) or, if not reached, the maximum administered dose (MAD). Patients receive a single intratumoural injection of TSK-001, followed 1 hour later by NIR irradiation of the tumour. Three dose levels, expressed as a percentage of the tumour volume (volume/volume, vol/vol), will be evaluated:
- Cohort 1: TSK-001 10% vol/vol
- Cohort 2: TSK-001 15% vol/vol
- Cohort 3: TSK-001 20% vol/vol Up to 6 patients will be enrolled per cohort (maximum 18 patients in total). Dose escalation is achieved by increasing the injected volume of TSK-001 and follows the standard oncology 3+3 design. The Data Monitoring Committee (DMC) may also recruit additional patients at the current dose level. A Safety Review Committee (SRC) is responsible for decisions to escalate or de-escalate doses.
Three patients are allocated to each new dose level. Each dose level starts with a sentinel patient; if no dose-limiting toxicity (DLT) is observed during a 29-day observation period, the remaining 2 patients may be enrolled in parallel. If a DLT is observed in 1 of 3 patients, 3 additional patients are enrolled at the same dose level. If 2 or more patients experience a DLT at a given dose level, recruitment into that cohort is stopped and the dose is de-escalated until a dose level is reached at which no more than 1 of 6 patients has a DLT; this dose level is defined as the MTD. If no further DLTs are observed, escalation continues to the next dose level. Intermediate dose levels may be introduced to ensure patient safety and better define the MTD. If no more than 1 DLT is observed at the highest dose (20% vol/vol), 3 additional patients are treated at that level; if no more than 1 of these 6 patients has a DLT, this dose is defined as the MAD.
Part 2 - Dose expansion Part 2 starts once the MTD or MAD has been determined and aims to identify the recommended Phase 2 dose (RP2D). Patients receive 2 intratumoural injections of TSK-001 at the MTD or MAD, 2 weeks apart, each followed 1 hour later by NIR irradiation. Six patients will be enrolled initially (maximum 12). If 2 or more patients experience a DLT, recruitment is stopped and the dose may be de-escalated in 6 new patients. If no more than 1 patient experiences a DLT, the study proceeds to Part 3 at the tested dose. The SRC reviews safety data throughout the study and is responsible for de-escalation decisions.
Part 3 - Phase 2 extension Up to 42 patients with nBCC will receive 2 intratumoural injections of TSK-001 at the RP2D identified in Part 2, 2 weeks apart, each followed 1 hour later by NIR irradiation. If 2 or more patients experience a DLT, recruitment will be stopped and a lower dose may be considered.
Lesion temperature monitoring Lesion temperature is monitored with an infrared thermography device during irradiation. The target therapeutic temperature range is 42-45 °C.
Pharmacokinetic (PK) sub-study A total of 12 patients from Parts 1 and 2 (3 per Part 1 cohort and 3 in Part 2) will take part in the PK sub-study. Blood samples will be collected before treatment, 60 minutes after the first injection on Day 1, and 24 hours after the first injection (Day 2). Urine will be collected 0-24 hours and 24-48 hours after the first injection.
Statistical analysis A detailed Statistical Analysis Plan (SAP) will be finalised before the first patient's visit. Safety endpoints will be analysed descriptively and presented by study part and dose group. Continuous variables will be summarised by number of non-missing values, mean, standard deviation (SD), median, minimum and maximum; categorical variables by frequency counts and percentages. Where required, two-sided 95% confidence intervals (CIs) will be calculated and significance testing will use a two-sided 5% significance level. Missing data will not be imputed.
Analysis sets:
- Full Analysis Set (FAS): all enrolled participants; used for participant disposition, baseline demographics, protocol deviations and efficacy data.
- Safety Set: all participants who received at least one dose of TSK-001; used for all safety data.
- PK Set: all participants who received at least one dose of TSK-001 and have at least one PK concentration value.
Sample size:
- Parts 1 and 2: as this is a first-in-human study, no formal sample size calculation was performed. Up to 18 patients will be enrolled in Part 1 (3+3 design across 3 dose levels) and up to 12 patients in Part 2.
- Part 3: assuming a complete response (CR) rate of 95%, 35 evaluable patients will provide a two-sided 95% CI for the CR rate of approximately 80% to 100%. Allowing for a 20% dropout rate, 42 patients will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1: TSK-001 10% vol/vol + NIR laser | Experimental | 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)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. |
| Part 1 Cohort 2: TSK-001 15% vol/vol + NIR laser | Experimental | 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)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. |
| Part 1 Cohort 3: TSK-001 20% vol/vol + NIR laser | Experimental | 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)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. |
| Part 2: TSK-001 ×2 (14 days apart) at MTD/MAD + NIR | Experimental | 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)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. |
| Part 3: TSK-001 ×2 (14 days apart) at RP2D + NIR | Experimental | 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)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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)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. | Device | 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 |
Primary outcome
P1. Number of Participants With Treatment-Emergent Adverse Events (Parts 1 and 2)
Time frame: Day 1 (D1) to Day 180
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
P2. Number of Participants With Clinically Significant Laboratory Abnormalities (Parts 1 and 2)
Time frame: from baseline to Day 180
Description : Number of participants with at least one post-baseline haematology or clinical chemistry value judged clinically significant by the investigator. Unit : participants
P3. Number of Participants With Clinically Significant Vital Sign Abnormalities (Parts 1 and 2)
Time frame: baseline to Day 360
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
P4. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Parts 1 and 2)
Time frame: baseline to Day 360
Description : Number of participants with at least one post-baseline 12-lead ECG finding judged clinically significant by the investigator. Unit : participants
P5. Maximum Local Skin Response (LSR) Composite Score (Parts 1 and 2)
Time frame: Day 1 to Day 360
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
P6. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Parts 1 and 2)
Time frame: Day 1 to Day 360
Description : Number of participants with hypopigmentation, hyperpigmentation or scarring at the treated site, as assessed by the investigator. Unit : participants
P7. Maximum Pain Intensity on a Visual Analogue Scale (Parts 1 and 2)
Time frame: Day 1 to Day 360
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
P8. Maximum Lesion Temperature During NIR Irradiation (Parts 1 and 2)
Time frame: during irradiation on Day 1 (and Day 15 in Part 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
P9. Percentage of Participants With Complete Response (Part 3)
Time frame: Day 29
Description : Complete response is defined as disappearance of the target lesion according to RECIST v1.1, measured with digital callipers. Unit : percentage of participants
P10. Percentage of Participants With No Residual Tumour on Histology (Part 3)
Time frame: At excision (Day 29 to Day 180) or Day 180
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
19 secondary outcomes
S1. Maximum Plasma Gold Concentration (Cmax) (Parts 1 and 2)
Time frame: Before injection, 60 min and 24 h after the first injection
S2. Time to Maximum Plasma Gold Concentration (Tmax) (Parts 1 and 2)
Time frame: 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)
Time frame: Before injection, 60 min and 24 h after the first injection
S4. Amount of Gold Excreted in Urine (Parts 1 and 2)
Time frame: 0-24 h and 24-48 h after the first injection
S5. Gold Concentration in Tumour Tissue (All Parts)
Time frame: 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)
S6. Percentage of Participants With Complete Response (Parts 1 and 2)
Time frame: Day 29
S7. Percentage of Participants With Complete Clinical and Dermoscopic Clearance (All Parts)
Time frame: Day 29
S8. Percentage of Participants With Histological Clearance (Parts 1 and 2)
Time frame: Day 29 (Part 1) and Day 75 (Part 2)
S9. Stony Brook Scar Evaluation Scale (SBSES) Total Score (Part 3)
Time frame: Days 15, 29, 43, 90 and 180
S10. Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale Total Score (Part 3)
Time frame: Days 15, 29, 43, 90 and 180
S11. POSAS - Observer Scale Total Score (Part 3)
Time frame: Days 15, 29, 43, 90 and 180
S12. Number of Participants With Treatment-Emergent Adverse Events (Part 3)
Time frame: Day 1 to Day 360
S13. Number of Participants With Clinically Significant Laboratory Abnormalities (Part 3)
Time frame: Baseline to Day 360
S14. Number of Participants With Clinically Significant Vital Sign Abnormalities (Part 3)
Time frame: baseline to Day 360
S15. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Part 3)
Time frame: Baseline to Day 360
S16. Maximum Local Skin Response (LSR) Composite Score (Part 3)
Time frame: Day 1 to Day 360
S17. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Part 3)
Time frame: Day 1 to Day 360
S18. Maximum Pain Intensity on a Visual Analogue Scale (Part 3)
Time frame: Day 1 to Day 360
S19. Maximum Lesion Temperature During NIR Irradiation (Part 3)
Time frame: During irradiation on Day 1 and Day 15
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- BackgroundPesnel 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
- Individual participant dataSharing planned: No. Individual participant data will not be shared. This is a small first-in-human study (up to 78 participants) that includes standardised clinical photographs of skin lesions, some on the face, which carry a high risk of re-identification even after pseudonymisation. Data are processed under the EU General Data Protection Regulation, and the informed consent does not cover sharing of individual data with third parties. Aggregate results will be made publicly available through the EU medical device database (EUDAMED) in accordance with Regulation (EU) 2017/745, posted on this registry, and submitted for publication in a peer-reviewed journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Oldfield, Dr principal investigator
Medical Research Institute of New Zealand (MRINZ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TSK-001. Injectable solution of glucose-functionalised plasmonic gold nanoparticles (0.3 mg in 1 mL water for injection) for intratumoural administration. and 808 nm near-infrared (NIR) diode laser (Hyper Diode 808) in people with Nodular BCC, run by Torskal SAS at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julie Jones (+64223553088 ext. +64, Julie.Jones@aptclinicaltrials.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P1. Number of Participants With Treatment-Emergent Adverse Events (Parts 1 and 2) (time frame: Day 1 (D1) to Day 180). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07891949, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.