Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 2

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)

NCT06926868 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • DRUG Carboplatin
  • DRUG Capecitabine
  • DRUG Paclitaxel
  • DRUG Nab-paclitaxel
  • DRUG Iza-bren

Study Locations (20)

California

  • Helios Clinical Research — Cerritos
  • Local Institution - 0307 — Cerritos
  • Local Institution - 0308 — Cerritos
  • Local Institution - 0309 — Cerritos
  • Local Institution - 0311 — Long Beach
  • USC/Norris Comprehensive Cancer Center — Los Angeles
  • Valkyrie Clinical Trials — Los Angeles
  • USC Norris Oncology/Hematology-Newport Beach — Newport Beach
  • Local Institution - 0358 — Stanford

Illinois

  • Local Institution - 0278 — Chicago
  • Local Institution - 0280 — Chicago
  • Decatur Memorial Hospital — Decatur

Colorado

  • Local Institution - 0289 — Aurora
  • Rocky Mountain Cancer Centers — Denver

Florida

  • Local Institution - 0282 — Miami
  • Local Institution - 0296 — Pembroke Pines

Georgia

  • Local Institution - 0294 — Atlanta
  • Northside Hospital — Atlanta

Arkansas

  • Local Institution - 0303 — Hot Springs

Delaware

  • Medical Oncology Hematology Consultants, PA — Newark

Trial Details

FieldValue
Enrollment Target 500 participants
Start Date 2025-09-11
Est. Completion 2030-05-15
Phase Phase 2

Sponsor

Bristol-Myers Squibb

504 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06926868

The ClinicalTrials.gov registry entry for NCT06926868 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Breast Neoplasms appearing as the primary indexed condition, and to 5 interventions — of which Carboplatin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06926868 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Illinois, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06926868 about?

NCT06926868 is a clinical study titled "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)". 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...

What is the current status of trial NCT06926868?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 500 participants. The study started on 2025-09-11. Estimated completion is 2030-05-15.

What conditions does trial NCT06926868 study?

This clinical trial studies the following conditions: Breast Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06926868?

The interventions under investigation include: Carboplatin (DRUG), Capecitabine (DRUG), Paclitaxel (DRUG), Nab-paclitaxel (DRUG), Iza-bren (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06926868?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06926868 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial