Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer

Recruiting now · Phase 1

Conditions studied: Advanced HR+/HER2- Breast Cancer

In brief

The purpose of this study is to evaluate the safety, tolerability and preliminary activity of IEV407 as a single agent and in combination with endocrine therapy (fulvestrant or letrozole) in patients with advanced hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-negative) breast cancer.

Key facts

Study ID

NCT07604571

Run by

Novartis Pharmaceuticals

People needed

194

Starts

2026-05-28

Expected to finish

2032-06-08

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years old
• Patients with one of the following indications:
• Dose escalation (IEV407 single agent and in combination with fulvestrant or letrozole):
• HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at least one line of endocrine-based therapy in combination with a CDK4/6 inhibitor and at least one additional line of systemic therapy in the unresectable/metastatic setting and not be a candidate for any available standard therapy, in the investigator's judgement.
• Dose expansion of IEV407 in combination with fulvestrant: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, endocrine-based therapy in combination with a CDK4/6 inhibitor. They must not have received more than two prior lines of endocrine-based therapy in the unresectable/metastatic setting. Prior cytotoxic chemotherapy and/or antibody-drug conjugate therapies in the unresectable/metastatic setting are not allowed.

You may not qualify if…

• Patients with inadequate bone marrow and/or organ functions with out-of-range laboratory values.
• Impaired cardiac function or clinically significant cardiac disease.
• Concurrent use of hormone replacement therapy.
• Women of childbearing potential who are unwilling to use highly effective contraception methods, pregnant or nursing women.
• For the combination treatment of IEV407 with fulvestrant or letrozole: Patients with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine-based therapy.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Mary Crowley Cancer Research — Dallas, Texas, United States (enrolling)
• Novartis Investigative Site — Hirakata, Osaka, Japan (enrolling)
• Novartis Investigative Site — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.