Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IEV407, Fulvestrant, Letrozole.
- Who it may be relevant to
- Registry conditions: Advanced HR+/HER2- Breast Cancer. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Japan, Singapore
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-label, Multi-center, Phase I/Ib Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer
Overview
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.
Detailed description
This is a first-in-human, open-label, phase I/Ib, multi-center study consisting of a dose escalation part of IEV407 as a single agent (SA) and in combination with endocrine therapy (fulvestrant or letrozole) followed by a dose expansion part in patients with advanced breast cancer (aBC). The study will start with the evaluation of IEV407 as a SA.
Following evaluation of IEV407 in combination with fulvestrant through dose escalation and establishment of a recommended dose and/or dose ranges for optimization (RD/DRO), the study may proceed to the Phase Ib expansion part to evaluate the combination treatment of IEV407 with fulvestrant. If more than one treatment arm is open concurrently in the dose expansion part, a randomization schedule will be employed for patient allocation.
Interventions
- Drug IEV407
Oral administration - Drug Fulvestrant
Intramuscular injection. Approved medication. - Drug Letrozole
Oral administration. Approved medication.
Primary outcome measures
- Incidence and severity of dose-limiting toxicities (DLTs) [Time frame: 28 days]
- Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Up to approximately 2 years]
- Frequency of dose interruptions, reductions and discontinuations [Time frame: Up to approximately 2 years]
- Dose intensity [Time frame: Up to approximately 2 years]
Secondary outcome measures (8)
- Best Overall Response (BOR) [Time frame: Up to approximately 2 years]
- Overall Response Rate (ORR) [Time frame: Up to approximately 2 years]
- Disease Control Rate (DCR) [Time frame: Up to approximately 2 years]
- Clinical Benefit Rate (CBR) [Time frame: Up to approximately 2 years]
- Duration of Response (DOR) [Time frame: Up to approximately 2 years]
- Progression Free Survival (PFS) [Time frame: Up to approximately 2 years]
- Maximum plasma concentration (Cmax) of IEV407 [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days]
- Area under the plasma concentration-time curve (AUC) of IEV407 [Time frame: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mary Crowley Cancer Research — Dallas
Japan · 1 center
- Novartis Investigative Site — Hirakata
Singapore · 1 center
- Novartis Investigative Site — Singapore
Identifiers
NCT: NCT07604571 · CIEV407A12101 · 2025-522707-26