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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Sacituzumab Tirumotecan 5mg/kg intravenously (IV) infusion every 2 weeks on Day 1, Tagitanlimab 900mg IV every 2 weeks on Day 1, until disease progression, unacceptable toxic effects, withdrawal from the trial, or death, whichever occurred first.
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Objective Response Rate (ORR) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
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.
Time frame: up to approximately 60 months
Progression Free Survival (PFS) as Assessed by Investigator per RECIST Version 1.1
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Time frame: up to approximately 60 months
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Time frame: up to approximately 60 months
Disease control response (DCR) as Assessed by Investigator per RECIST Version 1.1
DCR is defined as the proportion of participants who achieve a complete response (CR), partial response (PR) or or stable disease (SD) .
Time frame: up to approximately 60 months
Duration of response (DoR)
DoR is defined as the time from the first objective response (CR/PR) to the first documented disease progression (PD) according to RECIST v1.1 or death from any cause, whichever comes first.
Time frame: up to approximately 60 months
Safety and Tolerability
Incidence and severity of AEs and SAEs (per CTCAE 5.0)
Time frame: up to approximately 60 months
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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)
Mean change from baseline in the EORTC QLQ-C30
Time frame: 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)
Mean change from baseline in the EORTC QLQ-BR23
Time frame: up to approximately 60 months