Approval Probability
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Adjusted LOA
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Antibody-Drug Conjugates · 1 trial · 3 indications
defined as the Severity of Alopecia Tool (SALT) score greater than zero The SALT score is calculated as follows: 1. Divide the scalp into four equal quadrants: frontal, right, left, and occipital. 2. For each quadrant, visually estimate the extent of hair loss, expressed as a percentage. These percentages are recorded as whole numbers (e.g., 0%, 10%, 25%, 50%, etc.). 3. Calculate the overall SALT score by summing up the percentages from all four quadrants and dividing by 4. A SALT score of 0 indicates no hair loss. A SALT score of 100 indicates complete hair loss across the scalp. A score of 50 or greater is generally considered indicative of severe hair loss. assessed by blinded central dermatological review.
| Arm | Type | Description |
|---|---|---|
| Experimental | EXPERIMENTAL | Scalp cooling |
| Control | OTHER | Observation |
| Name | Type | Description |
|---|---|---|
| scalp cooling | DEVICE | scalp cooling at -10°C for each cycle of ADC, subjects will ubdergo scalp cooling : 30 minutes prior ADC treatment, during ADC treatment and 90 minutes following ADC treatment |
| photographs via the Belle.AI app | OTHER | artificial intelligence-based software tool designed for standardised photographic documentation and automated assessment of alopecia severity using the Severity of Alopecia Tool (SALT) scale generated AI Score will be blinded for investigator and patient outcome does not impact treatment of the subject |
| Antibody-Drug Conjugates | DRUG | study will randomize female participants receiving one of the following ADCs as part of their standard-of-care treatment: sacituzumab-govitecan, trastuzumab-deruxtecan, or datopotamab-deruxtecan. |
Inclusion Criteria: 1. Female 2. Age ≥ 18 years 3. ECOG performance status (PS) 0-2 4. Participants with visible scalp hair at baseline, without significant thinning or hair loss (CTCAE \< 2) 5. Participants with histologically or cytologically confirmed advanced or metastatic solid tumour 6. Plann...
Antibody-Drug Conjugates is an investigational small molecule being studied for the prevention of alopecia in female patients with advanced or metastatic solid tumours who are receiving treatment with an antibody-drug conjugate. It is currently in Phase 2 clinical development.
Antibody-Drug Conjugates is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The company is conducting a Phase 2 clinical trial to evaluate this investigational therapy.
Antibody-Drug Conjugates is in Phase 2 clinical development. It is an investigational agent and has not been approved by regulatory authorities. A single Phase 2 trial is planned, with an enrollment target of 102 female participants.
Antibody-Drug Conjugates is being evaluated in a Phase 2 clinical trial with the identifier NCT07474558. The trial, titled 'SCALp Cooling for pReventing aLopecia With nEw anTibody-drug Conjugates', is a randomized, controlled study enrolling 102 female patients in Belgium.
Antibody-Drug Conjugates is the name of the investigational therapy being studied, and it is a type of antibody-drug conjugate. The trial focuses on preventing alopecia in patients receiving such conjugates, but the specific drug itself is not further identified in the available information.