NIPH Clinical Trials Search

Study of Izalontamab Brengitecan(BMS-986507)versus Treatment of Physician's Choice in Patients with Previously Untreated,Locally Advanced, Recurrent Inoperable,or MetastaticTriple-negative Breast CancerIneligible for anti-PD(L)1-based Treatments

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients with TNBC or ER-low, HER2-negative BC who are Ineligible for Anti PD1/PD-L1 Treatment
Date of first enrollment	01/10/2025
Target sample size	40
Countries of recruitment	Argentina,Japan,Australia,Japan,Austria,Japan,Brazil,Japan,Canada,Japan,Colombia,Japan,France,Japan,Germany,Japan,Greece,Japan,India,Japan,Israel,Japan,Italy,Japan,Korea,Japan,Mexico,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Spain,Japan,Sweden,Japan,Switzerland,Japan,UAE,Japan,United Kingdom,Japan,United States,Japan,Chile,Japan,South Africa,Japan,China,Japan
Study type	Interventional
Intervention(s)	Phase2 Arm A1:2.0 mg/kg iza-bren D1D8Q3W Arm A2:2.5 mg/kg iza-bren D1D8Q3W Arm B:TPC Specified dose on specified days Phase3 Arm A:iza-bren RP3D Arm B:TPC Specified dose on specified days

Outcome(s)

Primary Outcome	PFS by RECIST v1.1 per BICR
Secondary Outcome	OS,Investigator-assessed PFS, Per BICR and investigator-assessed:(OR byRECIST v1.1,DCR,DOR,TTR),TTST,PFS2

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	-Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER < 1%, PgR < 1%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) or ER-low, HER2-negative BC (ER and / or PgR 1% to 10%, HER2 IHC 0, 1+, or 2+ with FISH negative for HER2 gene amplification) per ASCO/CAP criteria, based on the most recently analyzed biopsy or other pathology specimen. -Patients with recurrent disease must have experienced disease relapse at least 6 months after finishing their last therapy with curative intent. -Patients with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 or an anti-PD-L1 due to either one of the following criteria:. -Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC. -Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1. -Has a severe auto-immune disease or other contraindication. -Patients with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments. -No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie incurable setting). -Measurable disease by CT or MRI as per RECIST v1.1.
Exclude criteria	-Participants with history of severe heart disease -Participants with Grade >= 3 lung disease defined according to NCI-CTCAE v5.0, or a history of interstitial lung disease (ILD) or pneumonitis. -Prior history of clinically significant bleeding, intestinal obstruction, or perforation of the gastrointestinal tract within 3 months of randomization that has not recovered to Grade <=1.