Trial · NCT07891949
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | P1. Number of Participants With Treatment-Emergent Adverse Events (Parts 1 and 2) | 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 |
| Primary | P2. Number of Participants With Clinically Significant Laboratory Abnormalities (Parts 1 and 2) | 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 |
| Primary | P3. Number of Participants With Clinically Significant Vital Sign Abnormalities (Parts 1 and 2) | 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 |
| Primary | P4. Number of Participants With Clinically Significant 12-Lead ECG Abnormalities (Parts 1 and 2) | 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 |
| Primary | P5. Maximum Local Skin Response (LSR) Composite Score (Parts 1 and 2) | 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 |
| Primary | P6. Number of Participants With Pigmentation Changes or Scarring at the Treated Site (Parts 1 and 2) | 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 |
| Primary | P7. Maximum Pain Intensity on a Visual Analogue Scale (Parts 1 and 2) | 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 |
| Primary | P8. Maximum Lesion Temperature During NIR Irradiation (Parts 1 and 2) | 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 |
| Primary | P9. Percentage of Participants With Complete Response (Part 3) | 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 |
| Primary | P10. Percentage of Participants With No Residual Tumour on Histology (Part 3) | 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 |
| Secondary | S1. Maximum Plasma Gold Concentration (Cmax) (Parts 1 and 2) | Before injection, 60 min and 24 h after the first injection | 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 |
| Secondary | S2. Time to Maximum Plasma Gold Concentration (Tmax) (Parts 1 and 2) | Before injection, 60 min and 24 h after the first injection | Description : Tmax after the first TSK-001 injection, in the PK subset. Unit : hours |
| Secondary | 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 | Description : AUC0-24h calculated by non-compartmental analysis, in the PK subset. Unit : ng·h/mL |
| Secondary | S4. Amount of Gold Excreted in Urine (Parts 1 and 2) | 0-24 h and 24-48 h after the first injection | Description : Amount of gold excreted in urine over each collection interval, in the PK subset. Unit : µg |
| Secondary | 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) | Description : Gold concentration in tumour tissue measured by ICP-MS, from the punch biopsy and from the excised lesion. Unit : µg/g of tissue |
| Secondary | S6. Percentage of Participants With Complete Response (Parts 1 and 2) | Day 29 | Description : Disappearance of the target lesion according to RECIST v1.1. Unit : percentage of participants |
| Secondary | S7. Percentage of Participants With Complete Clinical and Dermoscopic Clearance (All Parts) | Day 29 | 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 |
| Secondary | S8. Percentage of Participants With Histological Clearance (Parts 1 and 2) | Day 29 (Part 1) and Day 75 (Part 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 |
| Secondary | S9. Stony Brook Scar Evaluation Scale (SBSES) Total Score (Part 3) | Days 15, 29, 43, 90 and 180 | Description : Investigator-rated scar assessment, total score ranging from 0 (worst) to 5 (best). Unit : score on a scale |
| Secondary | S10. Patient and Observer Scar Assessment Scale (POSAS) - Patient Scale Total Score (Part 3) | Days 15, 29, 43, 90 and 180 | 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 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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