IEV407 as a single agent or with endocrine therapy for advanced HR+/HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human, open-label, phase 1/1b trial conducted at multiple centers. It uses a dose-escalation approach to determine a safe dose of IEV407 as a single agent and in combination with endocrine therapies, followed by a potential expansion phase to further evaluate the combination with fulvestrant. Participants have advanced HR+/HER2- breast cancer and have previously received endocrine therapy with CDK4/6 inhibition, with restrictions on prior chemotherapy in the expansion cohort. Randomization may occur during the dose-expansion phase if multiple arms are open. Interventions include IEV407, fulvestrant, and letrozole, with primary focus on safety and tolerability and preliminary anti-tumor activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Yale New Haven Hospital
  New Haven, Connecticut, United States Recruiting
• Univ of Kansas Hosp and Med Ctr
  Kansas City, Kansas, United States Recruiting
• Mary Crowley Cancer Research
  Dallas, Texas, United States Recruiting
• Novartis Investigative Site
  Toronto, Ontario, Canada Recruiting
• Novartis Investigative Site
  Marseille, France Recruiting
• Novartis Investigative Site
  Toulouse, France Recruiting

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: 1-888-669-6682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.