Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
- Summary
- 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.
- Short title
- Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2032-06-08
- First posted
- 2026-05-22
- Registry last updated
- 2026-08-27
- Primary completion date
- 2032-06-08
- Start date
- 2026-05-28
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novartis Pharmaceuticals
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07604571
- ClinicalTrials.gov ID
- NCT07604571
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Sequential
- Purpose
- Treatment
- Masking
- No masking
Incidence and severity of dose-limiting toxicities (DLTs)
Timeframe: 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.
Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 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.
Frequency of dose interruptions, reductions and discontinuations
Timeframe: Up to approximately 2 years
Number of participants with dose adjustments (interruptions, reductions, or permanent discontinuation) as a measure of tolerability.
Dose intensity
Timeframe: Up to approximately 2 years
Dose intensity defined as the ratio of actual cumulative dose received and actual duration of exposure.
Best Overall Response (BOR)
Timeframe: 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.
Overall Response Rate (ORR)
Timeframe: 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.
Disease Control Rate (DCR)
Timeframe: 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.
Clinical Benefit Rate (CBR)
Timeframe: 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.
Duration of Response (DOR)
Timeframe: 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.
Progression Free Survival (PFS)
Timeframe: 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.
Maximum plasma concentration (Cmax) of IEV407
Timeframe: 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.
Area under the plasma concentration-time curve (AUC) of IEV407
Timeframe: 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.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
-
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.
- 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.
- Yale New Haven HospitalNew Haven, United StatesRecruiting
- Mary Crowley Cancer ResearchDallas, United StatesRecruiting
- Novartis Investigative SiteToronto, CanadaRecruiting
- Novartis Investigative SiteHirakata, JapanRecruiting
- Novartis Investigative SiteSingapore, SingaporeRecruiting
- 2025
- 2025-522707-26