NCT07153965
Not yet recruiting
Phase 2
An Open-label, Single-arm, Multicenter Phase II Study of Sacituzumab Tirumotecan (Sac-TMT) Plus Tagitanlimab in Previously Treated PD-L1-positive Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)
Tianjin Medical University Cancer Institute and Hospital1 site in 1 country47 target enrollmentStarted: September 1, 2025Last updated:
InterventionsSacituzumab Tirumotecan plus Tagitanlimab
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 47
- Locations
- 1
- Primary Endpoint
- Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Overview
Brief Summary
This is an open-label, single-arm, multicenter phase II study to evaluate the safety and efficacy of sac-TMT plus Tagitanlimab in patients with PD-L1-positive locally advanced or metastatic TNBC.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
sac-TMT plus Tagitanlimab
Experimental
Intervention: Sacituzumab Tirumotecan plus Tagitanlimab (Drug)
Outcomes
Primary Outcomes
Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame: up to approximately 60 months
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Secondary Outcomes
- Progression Free Survival (PFS) as Assessed by Investigator per RECIST Version 1.1(up to approximately 60 months)
- Overall Survival (OS)(up to approximately 60 months)
- Disease control response (DCR) as Assessed by Investigator per RECIST Version 1.1(up to approximately 60 months)
- Safety and Tolerability(up to approximately 60 months)
- Duration of response (DoR)(up to approximately 60 months)
- Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)(up to approximately 60 months)
- Health-related quality of life (HRQoL) evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Breast Cancer Module 23 (EORTC QLQ-BR23)(up to approximately 60 months)
Investigators
Study Sites (1)
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