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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат IEV407
  Oral administration
• Препарат Fulvestrant
  Intramuscular injection. Approved medication.
• Препарат Letrozole
  Oral administration. Approved medication.

Первичные конечные точки

• Incidence and severity of dose-limiting toxicities (DLTs) [Срок оценки: 28 days]
• Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to approximately 2 years]
• Frequency of dose interruptions, reductions and discontinuations [Срок оценки: Up to approximately 2 years]
• Dose intensity [Срок оценки: Up to approximately 2 years]

Вторичные конечные точки (8)

• Best Overall Response (BOR) [Срок оценки: Up to approximately 2 years]
• Overall Response Rate (ORR) [Срок оценки: Up to approximately 2 years]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 2 years]
• Clinical Benefit Rate (CBR) [Срок оценки: Up to approximately 2 years]
• Duration of Response (DOR) [Срок оценки: Up to approximately 2 years]
• Progression Free Survival (PFS) [Срок оценки: Up to approximately 2 years]
• Maximum plasma concentration (Cmax) of IEV407 [Срок оценки: 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 [Срок оценки: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Mary Crowley Cancer Research — Dallas

Япония · 1 центр

• Novartis Investigative Site — Hirakata

Сингапур · 1 центр

• Novartis Investigative Site — Singapore

Идентификаторы

NCT: NCT07604571 · CIEV407A12101 · 2025-522707-26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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