The WIN B Study
Research type
Research Study
Full title
PHASE IB/II STUDY TO EVALUATE SAFETY AND PRELIMINARY EFFICACY OF THE WEE1 INHIBITOR DEBIO 0123 IN COMBINATION WITH SACITUZUMAB GOVITECAN IN TRIPLE-NEGATIVE OR HR+/HER2– ADVANCED/METASTATIC BREAST CANCER (The WIN-B study)
IRAS ID
1011075
Contact name
Tea Borojevic
Contact email
Sponsor organisation
Medica Scientia Innovation Research (MEDSIR)
Clinicaltrials.gov Identifier
Research summary
This trial will focus on two types of breast cancer defined as advanced/metastatic TNBC or HR+/HER2– breast cancer. Patients will be treated with Debio 0123 (a new drug) in combination with Sacituzumab govitecan.
Debio 0123 is a new drug, currently being evaluated to treat solid tumours. Sacituzumab govitecan is a drug which is already approved for use in patients in the UK and other countries to treat metastatic HR-positive, HER2-negative breast cancer patients who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
This is an international study and approximately 64-76 participants will be enrolled. Patients can be male or female ≥18 years of age, those who consent to take part in the study will be screened to make sure they meet specific criteria. In UK, 5 sites will participate in the study.
This study involves two phases. There are four cohorts in this dose-escalation study, each receiving a different dose of Debio 0123. If the initial dose is deemed safe, the next cohort will begin with the subsequent higher dose.
In phase I, the objective is to find the safest dose for Debio 0123 when administered in combination with Sacituzumab govitecan.
In phase II, participants will receive the recommended dose of Debio 0123 determined in the phase Ib plus intravenous Sacituzumab govitecan until end of the treatment. The objective is to evaluate the efficacy of Debio 0123 at the recommended dose when administered in combination with Sacituzumab govitecan.
Participants will visit the clinic twice every cycle (on days 1 and 8 of each 21 day cycle) and different types of test e.g. blood tests, scans and ECGs will be performed.
The treatment, on average, may continue for approximately 9 months.REC name
London - Brent Research Ethics Committee
REC reference
25/LO/0078
Date of REC Opinion
26 Feb 2025
REC opinion
Further Information Favourable Opinion