Health TrialsbyHealthPanel

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)

ConditionBreast Neoplasms
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 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).

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Iza-bren

    Drug

    Specified dose on specified days

  • Nab-paclitaxel

    Drug

    Specified dose on specified days

  • Paclitaxel

    Drug

    Specified dose on specified days

  • Capecitabine

    Drug

    Specified dose on specified days

  • Carboplatin

    Drug

    Specified dose on specified days

  • Gemcitabine

    Drug

    Specified dose on specified days

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Arm A1Experimental treatment 1 intervention
Group B: Arm A2Experimental treatment 1 intervention
Group C: Arm BActive comparator 5 interventions

Trial outcomes

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)

Time frame
Approximately 31 months from first participant randomization

Secondary outcomes

1

Overall Survival (OS)

Time frame
Approximately up to 57 months from first participant randomization
2

Recommended Phase 3 Dose (RP3D) of BMS-986507

Time frame
Approximately 19 months from first participant randomization
3

Number of participants with treatment-related Adverse Events (AEs)

Time frame
Approximately up to 57 months from first participant randomization
4

Number of participants with laboratory abnormalities

Time frame
Approximately up to 57 months from first participant randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

SystImmune Inc.

Collaborator

Source ClinicalTrials.gov
Apply now