Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Debio 0123 and Sacituzumab govitecan · 1 trial · 1 indication
The RP2D of Debio 0123 when used in combination with Sacituzumab govitecan will be determined based upon evaluation of dose-limiting toxicities (DLTs), adverse events (AEs) and other available data from secondary endpoints.
ORR, defined as the rate of patients with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1 in patients with TNBC and HR+/HER2- advanced/metastatic breast cancer.
| Arm | Type | Description |
|---|---|---|
| Debio 0123 + Sacituzumab govitecan | EXPERIMENTAL | Phase Ib of the study will adopt the Bayesian Logistic Regression Model (BLRM) with Overdosing Control. Patients with TNBC and HR+/HER2- advanced/metastatic breast cancer will receive multiple doses of Debio 0123 administered orally during 6 days of each 21-day cycle and 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle in order to find the RP2D for Debio 0123 when administered in combination with Sacituzumab govitecan. In phase II study, patients with TNBC or HR+/HER2- advanced/metastatic breast cancer will receive the RP2D of Debio 0123 administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Debio 0123 and Sacituzumab govitecan | DRUG | Debio 0123 will be administered orally during 6 days of each 21-day cycle in combination with 10 mg/kg of Sacituzumab govitecan administered intravenously on D1 and D8 of each 21-day cycle until documented disease progression, death, unacceptable toxicity, or discontinuation from the study treatment for any other reason, whichever occurs first. |
Inclusion Criteria: 1. Patient must be capable to understand the purpose of the study and have signed written informed consent form (ICF) prior to beginning specific protocol procedures. 2. Female or male patients ≥ 18 years of age at the time of signing ICF. 3. Unresectable locally recurrent or me...
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Debio 0123 and Sacituzumab govitecan is an investigational combination being studied for the treatment of advanced breast cancer, specifically in patients with triple-negative breast cancer (TNBC) or hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer. It is currently in Phase 1 clinical development.
The combination of Debio 0123 and Sacituzumab govitecan is being evaluated for its anticancer activity in advanced breast cancer. Sacituzumab govitecan is an antibody-drug conjugate that targets Trop-2, a protein expressed on many solid tumors, while Debio 0123 is a small molecule. The specific molecular target of Debio 0123 is not disclosed in the available information.
Debio 0123 and Sacituzumab govitecan is being developed by Gilead Sciences, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol GILD. The combination is being studied in a Phase 1 clinical trial for advanced breast cancer.
Debio 0123 and Sacituzumab govitecan is in Phase 1 clinical development. It is an investigational combination therapy and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling participants to evaluate the safety and efficacy of the combination in advanced breast cancer.
Debio 0123 and Sacituzumab govitecan is being studied in a single Phase 1 clinical trial with the identifier NCT06612203. This trial is titled 'Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer' and is active but not recruiting participants. The trial is enrolling 76 patients in Spain and the United Kingdom.
No, Debio 0123 and Sacituzumab govitecan is a combination therapy that includes sacituzumab govitecan, an antibody-drug conjugate, plus Debio 0123, a small molecule. This combination is being investigated as a potential treatment for advanced breast cancer, whereas sacituzumab govitecan alone is an approved therapy for certain breast cancer indications.