Trial · NCT06612203
Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
NCT06612203, Phase 1, Phase 2, Active not recruiting, MedSIR
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer. Trials, record NCT06612203. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06612203
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study to Evaluate Debio0123 + Sacituzumab Govitecan Combination in TNBC or HR+/HER2- Advanced Breast Cancer
- NCT number
- NCT06612203
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- MedSIR
- Conditions
- Advanced Breast Cancer
- Interventions
- Debio 0123 and Sacituzumab govitecan
- First posted
- 2024-09-25
- Last updated
- 2025-12-05
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase Ib - Debio 0123's recommended phase II dose (RP2D) when administered in combination with Sacituzumab govitecan in patients with TNBC or HR+/HER2- metastatic breast cancer. | Baseline up to 42 days. | 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. |
| Primary | Phase II - Efficacy in terms of objective response rate (ORR) as per RECIST v.1.1 in each cohort. | Approximately 9 months from baseline. | 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. |
| Secondary | Safety and tolerability. | Approximately 9 months from baseline. | Measures will include AEs and treatment-emergent AEs (TEAEs), including NCI CTCAE v5.0 severity grade and relationship to study drugs. |
| Secondary | Preliminary objective response rate (ORR) in TNBC and HR+/HER2- advanced/metastatic breast cancer patients. | Approximately 9 months from baseline. | ORR, defined as the rate of patients with complete response (CR) or partial response (PR), as determined locally by the Investigator. |
| Secondary | Efficacy in terms of PFS as per RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial lesions in patients with metastatic TNBC and HR+/HER2- advanced/metastatic breast cancer patients. | Approximately 9 months from baseline. | PFS, defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as determined locally by the Investigator. |
| Secondary | Clinical benefit rate (CBR) based on local Investigator assessment as per RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial and overall lesions in TNBC and HR+/HER2- advanced/metastatic breast cancer patients. | Approximately 9 months from baseline. | CBR, defined as the rate of patients with an objective response (CR or PR), or stable disease for at least 24 weeks, based on local Investigator assessment in all patients. |
| Secondary | Time to response (TTR) based on local Investigator assessment as per RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial and overall lesions in TNBC and HR+/HER2- advanced/metastatic breast cancer patients. | Approximately 9 months from baseline. | TTR, defined as the period from start of treatment to time of the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a BOR of CR or PR, based on local Investigator assessment in all patients. |
| Secondary | Duration of response (DoR) based on local Investigator assessment as per RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial in TNBC and HR+/HER2- advanced/metastatic breast cancer patients. | Approximately 9 months from baseline. | DoR, defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, based on local Investigator assessment in all patients. |
| Secondary | Efficacy in terms of overall survival (OS) as per RECIST v.1.1 in TNBC and HR+/HER2- advanced/metastatic breast cancer patients. | Approximately 9 months from baseline. | OS, defined as the period from treatment initiation to death from any cause, as determined locally by the investigator in patients with TNBC and HR+/HER2- advanced/metastatic breast cancer. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06612203
GET https://conductscience.org/api/trials/v1/NCT06612203/registered