Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07604571 · ClinicalTrials.gov registry record · Phase 1
Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 194
- Enrollment target
NCT07604571: Recruiting Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT07604571 is a Phase 1 study that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 194 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (223% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07604571, a Phase 1 study, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 194 participants
- Enrollment target
Study 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.
Primary Outcome
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 wit
Interventions
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG IEV407
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 194 participants |
| Start Date | 2026-05-28 |
| Est. Completion | 2032-06-08 |
| Phase | Phase 1 |
What NCT07604571 shows while recruiting
NCT07604571 is an interventional study that assigns participants to a tested intervention. The registered 194 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (223% higher).
The record links to 0 conditions, and to 3 interventions - of which Letrozole is the first listed.
NCT07604571 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07604571 about?
NCT07604571 is a clinical study titled "Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- 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 (HE...
What is the current status of trial NCT07604571?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 194 participants. The study started on 2026-05-28. Estimated completion is 2032-06-08.
What interventions are being tested in trial NCT07604571?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), IEV407 (DRUG).
Who is sponsoring clinical trial NCT07604571?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07604571's enrollment target sits among peer trials
194 282nd of 2000 higher than 1,719 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03593759 · 194 participants · Phase 3
Cardiac Sarcoidosis Randomized Trial
- NCT05053152 · 194 participants · Phase 2
Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study
- NCT05156112 · 194 participants · NA
OSA PAP Treatment for Veterans With SUD and PTSD on Residential Treatment Unit
- NCT05351424 · 194 participants · NA
AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI