OncoMatch/Clinical Trials/NCT06926868
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)
Is NCT06926868 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2/3 trial studies multiple treatments for breast neoplasms.
Treatment: Iza-bren · Nab-paclitaxel · Paclitaxel · Capecitabine · Carboplatin · Gemcitabine — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (ER < 1% (TNBC) or ER 1-10% (ER-low))
ER < 1% (TNBC) or ER and/or PgR 1% to 10% (ER-low)
Required: PR (PGR) expression (PgR < 1% (TNBC) or PgR 1-10% (ER-low))
PgR < 1% (TNBC) or ER and/or PgR 1% to 10% (ER-low)
Required: HER2 (ERBB2) wild-type (IHC 0, 1+, or 2+ with ISH negative)
HER2 IHC 0, 1+, or 2+ with ISH negative for HER2 gene amplification
Excluded: BRCA1 germline mutation
Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi)
Excluded: BRCA2 germline mutation
Participants with a known germline breast cancer gene (BRCA) 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a poli-ADP-ribose-polymerase inhibitors (PARPi)
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
Prior therapy
Cannot have received: izalontamab brengitecan or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload
Prior therapy with iza-bren or any other ADC targeting EGFR and/or HER3 or containing a topoisomerase 1 inhibitor payload
Lab requirements
Cardiac function
History of clinically significant heart disease (e.g., cardiomyopathy, congestive heart failure NYHA II-IV, pericarditis, significant pericardial effusion), myocardial infarction, uncontrolled angina, or stroke/TIA within past 6 months, QTc prolongation ≥ 450 msec (males) or ≥ 470 msec (females), known LVEF < 50%
Participants with history of severe heart disease including, but not limited to, any of the following: ... (see exclusion criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Local Institution - 0303 · Hot Springs, Arkansas
- Helios Clinical Research · Cerritos, California
- Local Institution - 0307 · Cerritos, California
- Local Institution - 0308 · Cerritos, California
- Local Institution - 0309 · Cerritos, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06926868 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Are patients with BRCA1 alterations eligible?
No. BRCA1 germline mutation is an exclusion criterion.
Are patients with BRCA2 alterations eligible?
No. BRCA2 germline mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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