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 Ineligible for anti-PD(L)1-based Treatments

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

11 Nov 2025 → ongoing

Decision date (initial)

2025-10-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bristol-Myers Squibb Services Unlimited Company

External identifiers

EU CT number

2024-519871-24-00

WHO UTN

U1111-1316-1533

ClinicalTrials.gov

NCT06926868

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Dose response, Efficacy

The main goal of this study is to find the right dose of a new medicine called iza-bren, and to check if it works better than some other common chemotherapy treatments chosen by the doctors (like paclitaxel, nab-paclitaxel, capecitabine, or carboplatin plus gemcitabine) in helping people with TNBC or ER-low, HER2-negative BC that can't be removed by surgery or has spread to other parts of the body.

Secondary objectives 4

1. To see if people live longer when they take iza-bren compared to the other treatments.
2. Comparing how well iza-bren works in other ways, how safe it is, and how well people tolerate it compared to the other treatments
3. To see if the quality of life of people taking iza-bren is better than those taking the other treatments
4. To compare how safe and effective two different doses of iza-bren are compared to the other treatments.

Conditions and MedDRA coding

Breast cancer

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and partners/clinical-trials-and-research/disclosure-commitment.html

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 10

1. Participants who have advanced TNBC or ER-low, HER2-negative BC that can't be removed by surgery or has spread to other parts of the body, and have not received prior treatments at this stage of their disease
2. Participants with TNBC must be considered ineligible for 1L chemotherapy combination treatment with an anti-PD-1 (eg, pembrolizumab) or an anti-PD-L1 (eg, atezolizumab).
3. Participants with ER-low, HER2-negative BC must be ineligible, in the opinion of the Investigator, for endocrine therapy-based treatments.
4. No previous systemic therapy in the locally advanced, recurrent inoperable or metastatic setting (ie, in the incurable setting).
5. Measurable disease by CT or MRI as per RECIST v1.1. Bone-only disease is allowed provided it is measurable (ie, with soft tissue component). Note: If there is only one measurable lesion, and if a biopsy is performed on that lesion, baseline imaging should be performed at least 14 days after the biopsy.
6. Participants must have MRI of the brain within 28 days prior to randomization. CT scan can be used in the presence of contraindication to MRI (eg, pacemaker).
7. Eligible for at least 1 of the chemotherapy options listed as TPC (paclitaxel, nab-paclitaxel, capecitabine, or carboplatin plus gemcitabine) per investigator assessment.
8. ECOG performance status of 0 or 1.
9. Recovered from all toxicities from previous systemic therapies to Grade 1 or less by NCI CTCAE v5.0 (except alopecia or peripheral neuropathy that may be Grade 2 or less) at the time of randomization.
10. Participants must have completed all prior local cancer treatments at least 2 weeks prior to randomization (ie, radiotherapy and major surgery).

Exclusion criteria 9

1. Participants with a known germline BRCA 1 or 2 mutation whose best 1L treatment option, in the opinion of the investigator, is a PARPi.
2. Untreated symptomatic central nervous system (CNS) metastases. Participants are eligible if CNS metastases have been treated, and participants’ neurological signs and symptoms have returned to baseline. In addition, participants must have been either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization. Imaging performed within 28 days of randomization must document radiographic stability of CNS lesions and be performed after completion of any CNS directed therapy.
3. Leptomeningeal metastases.
4. Active viral hepatitis
5. Other clinically active infectious liver disease including co-infection with hepatitis B and C/D (either known or detected reflexively in a patient with stable HBV infection).
6. Known uncontrolled HIV infection.
7. Participants with known bleeding coagulation disorders, including but not limited to hemophilia, von Willebrand disease, or any other coagulopathies that may affect blood clotting.
8. Prior history of clinically significant bleeding, intestinal obstruction, or perforation of the gastrointestinal tract within 3 months of randomization that has not recovered to Grade <1.
9. Infection requiring antibiotic use within 1 week prior to randomization.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. PFS (progression-free survival) by BICR (Blinded Independent Central Review) The ability of iza-bren to work better than other common treatments chosen by the doctors is tested by looking at the PFS, which shows how long it takes for the disease to get worse by radiographic imaging techniques (like CT scans).

Secondary endpoints 1

1. This study will assess if people live longer when they take iza-bren compared to other treatments chosen by the doctors. This is what is called "Overall Survival"

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 6

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254, Blanchardstown Corporate Park 2 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 7

Locations

10 EU/EEA countries · 85 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 107 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications