Status:
RECRUITING
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
SystImmune Inc.
Conditions:
Breast Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physi...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed and documented locally-advanced, recurrent inoperable, or metastatic TNBC (ER \< 1%, PgR \< 1%, HER2 IHC 0, 1+, or 2+ with ISH 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 ISH 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:
- i) Investigator-determined ineligibility based on PD-L1 negative disease determined and documented prior to trial screening as part of SoC; ii) Has experienced disease relapse between 6 to 12 months after the completion of (neo)adjuvant therapy with an anti-PD(L)1; iii) 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.
- Other protocol-defined Inclusion/
Exclusion
- apply.
Key Trial Info
Start Date :
September 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 15 2030
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06926868
Start Date
September 11 2025
End Date
May 15 2030
Last Update
March 11 2026
Active Locations (293)
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1
Local Institution - 0303
Hot Springs, Arkansas, United States, 71913
2
Helios Clinical Research
Cerritos, California, United States, 90703
3
Local Institution - 0307
Cerritos, California, United States, 90703
4
Local Institution - 0308
Cerritos, California, United States, 90703