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

2026년 6월 1일 업데이트: Novartis Pharmaceuticals

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

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

194

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Novartis Pharmaceuticals
  • 전화번호: +41613241111

연구 장소

  • 싱가포르
      • Singapore, 싱가포르, 119074
        • 모병
        • Novartis Investigative Site

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Dose escalation: IEV407 single agent
IEV407 single agent
의약품: IEV407
Oral administration
실험적: Dose escalation: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
의약품: Fulvestrant
Intramuscular injection. Approved medication.
다른 이름들:
  • 파슬로덱스
의약품: IEV407
Oral administration
실험적: Dose escalation: IEV407 + letrozole
IEV407 in combination with letrozole
의약품: Letrozole
Oral administration. Approved medication.
다른 이름들:
  • 페마라
의약품: IEV407
Oral administration
실험적: Dose expansion, recommended dose (RD)-1: IEV407 + fulvestrant
IEV407 in combination with fulvestrant
의약품: Fulvestrant
Intramuscular injection. Approved medication.
다른 이름들:
  • 파슬로덱스
의약품: IEV407
Oral administration
실험적: Dose expansion, RD-2 (optional dose optimization): IEV407 + fulvestrant
IEV407 in combination with fulvestrant
의약품: Fulvestrant
Intramuscular injection. Approved medication.
다른 이름들:
  • 파슬로덱스
의약품: IEV407
Oral administration

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence and severity of dose-limiting toxicities (DLTs)
기간: 28 days
Number of participants with DLTs. A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher, including death, unless clearly and incontrovertibly assessed as due to disease, disease progression, inter-current illness/injury, concomitant medications, or extraneous causes, that occurs within the first 28 days of treatment with IEV407 in the dose escalation parts or in the expansion part of IEV407 in combination with fulvestrant with the exceptions described in the study protocol.
28 days
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: Up to approximately 2 years
Number of participants with AEs and SAEs, including changes in laboratory values, vital signs and echocardiograms (ECGs) qualifying and reported as AEs.
Up to approximately 2 years
Frequency of dose interruptions, reductions and discontinuations
기간: Up to approximately 2 years
Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
Up to approximately 2 years
Dose intensity
기간: Up to approximately 2 years
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Up to approximately 2 years

2차 결과 측정

결과 측정
측정값 설명
기간
Best Overall Response (BOR)
기간: Up to approximately 2 years
BOR per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) is defined as the best overall confirmed response recorded from the start of the treatment until progressive disease (PD), death, start of new therapy, withdrawal of consent or end of study, whatever comes first. Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Overall Response Rate (ORR)
기간: Up to approximately 2 years

ORR per RECIST v1.1 is defined as the proportion of patients with a BOR of Complete response (CR) or Partial response (PR).

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Disease Control Rate (DCR)
기간: Up to approximately 2 years

DCR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or Stable Disease (SD).

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Clinical Benefit Rate (CBR)
기간: Up to approximately 2 years

CBR per RECIST v1.1 is defined as the proportion of patients with a BOR of CR, PR, or an overall lesion response of SD or Non-CR/Non-PD which lasts for at least 24 weeks.

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Duration of Response (DOR)
기간: Up to approximately 2 years

DOR per RECIST v1.1 is the time between the first documented response (CR or PR) and the date of progression by local review as applicable or death due to any cause.

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Progression Free Survival (PFS)
기간: Up to approximately 2 years

PFS per RECIST 1.1 is defined as the time from the date of start of study treatment (Phase I) or the date of randomization (Phase II) to the date of the first documented progression or death due to any cause.

Efficacy will be based on the investigator assessment.
Up to approximately 2 years
Maximum plasma concentration (Cmax) of IEV407
기간: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days
Pharmacokinetic (PK) parameters based on plasma concentrations of IEV407.
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
기간: From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days
PK parameters based on plasma concentrations of IEV407.
From pre-dose up to 24 hours after dosing on Cycle 1 Day 1 and Day 15. 1 cycle = 28 days

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Novartis Pharmaceuticals

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 28일

기본 완료 (추정된)

2032년 6월 8일

연구 완료 (추정된)

2032년 6월 8일

연구 등록 날짜

최초 제출

2026년 5월 18일

QC 기준을 충족하는 최초 제출

2026년 5월 18일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 1일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CIEV407A12101
  • 2025-522707-26 (레지스트리 식별자: EU CTIS)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

고급 HR+/HER2- 유방암에 대한 임상 시험

Fulvestrant에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Croatia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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