NCT06926868|RecruitingPhase 2DMCFDA Drug

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)

IZABRIGHT-Breast01: A Randomized, Open-label, Inferentially Seamless Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Treatment of Physician's Choice in Patients With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer (TNBC) or ER-low, HER2-negative BC Who Are Ineligible for Anti-PD1/PD-L1 Treatment

Bristol-Myers Squibb ClinicalTrials.gov

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3 other identifiers

CA244-00082024-519871-24U1111-1316-1533

Study Type

interventional

Target

500

Locations

27 countries

Sites

289

Timeline

RegisteredApr 2025

StartedSep 2025

CompletionMay 2030

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 physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin plus gemcitabine, and capecitabine) for the treatment of first-line metastatic triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal growth factor receptor 2 (HER2)-negative BC patients who are not candidates for anti-PD(L)1 therapy and endocrine therapies.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

500

participants targeted

Target at P75+ for phase_2

Timeline

48mo left

Started Sep 2025

Longer than P75 for phase_2

Geographic Reach

27 countries

289 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.7 years study duration

Study Progress16%

Sep 2025May 2030

First Submitted

Initial submission to the registry

April 8, 2025

Completed

7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed

5 months until next milestone

Study Start

First participant enrolled

September 11, 2025

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2028

Expected

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2030

Last Updated

June 10, 2026

Status Verified

June 1, 2026

Enrollment Period

2.5 years

First QC Date

April 8, 2025

Last Update Submit

June 9, 2026

Conditions

Breast Neoplasms

Keywords

triple-negative breast cancerantibody-drug conjugateER-low/HER2-negative breast cancer

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival (PFS)
Assessed using Response Evaluation Criteriain Solid Tumors version 1.1 (RECIST v1.1) byblinded independent central review (BICR)
Approximately 31 months from first participant randomization

Secondary Outcomes (21)

Overall Survival (OS)
Approximately up to 57 months from first participant randomization
Recommended Phase 3 Dose (RP3D) of BMS-986507
Approximately 19 months from first participant randomization
Number of participants with treatment-related Adverse Events (AEs)
Approximately up to 57 months from first participant randomization
Number of participants with laboratory abnormalities
Approximately up to 57 months from first participant randomization
Number of participants with serious AEs (SAEs)
Approximately up to 57 months from first participant randomization
+16 more secondary outcomes

Study Arms (3)

Arm A1

EXPERIMENTAL

Drug: Iza-bren

Arm A2

EXPERIMENTAL

Drug: Iza-bren

Arm B

ACTIVE COMPARATOR

Drug: Nab-paclitaxelDrug: PaclitaxelDrug: CapecitabineDrug: CarboplatinDrug: Gemcitabine