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.
Age ≥ 18 years at the time of signing informed consent.
Definition of human epidermal growth factor receptor 2 (HER2) negative: immunohistochemistry (IHC) of 0 or 1+; if HER2 is 2+ by IHC, negative HER2 expression must be confirmed by fluorescencein situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC.
Tumor stage: locally advanced, recurrent, or metastatic TNBC; locally advanced cases must be confirmed by the investigator as unsuitable for curative surgical resection.
Those who have received chemotherapy combined with a PD-(L)1 inhibitor as first-line treatment for locally advanced or metastatic disease and experienced progression ≥ 3 months later.
Targeted TROP2 therapy.
Any drug treatment targeting topoisomerase I, including antibody drug conjugates (ADC) therapy.
Known to have meningeal metastasis, brainstem metastasis, spinalcord metastasis, and/or compression, active central nervous system(CNS) metastasis. Patients with previously treated brain metastases canparticipate if clinically stable for at least 4 weeks before dosing and do not require corticosteroids or anticonvulsants for at least 14 days. Patients with untreated asymptomatic brain metastases must require investigator approval.
Has a history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
Single group
Sacituzumab Tirumotecan plus Tagitanlimab
DrugSacituzumab 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.
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.
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.
Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
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) .
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.
TROP2, PD-L1, tumor-infiltrating lymphocytes (TILs), lymphocyte subpopulation
Explore potential biomarkers that predict the treatment response and prognosis of TNBC, including but not limited to the expression levels of TROP2, PD-L1, tumor-infiltrating lymphocytes (TILs), lymphocyte subpopulation.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
