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NCT06247995 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
A Phase 1 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 20
- Study locations
NCT06247995: Recruiting Phase 1 study of Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT06247995 is a Phase 1 study of Breast Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 58 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06247995, a Phase 1 study of Breast Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 20
- Study locations
Study Summary
In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast cancer after progression on previous endocrine therapy in combination with a CDK4/6 inhibitor. In the phase II part, to evaluate the preliminary anti-tumor activity of two different doses/regimens of \[177Lu\]Lu-NeoB in combination with capecitabine (dose optimization).
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness/injury, or concomitant medications that occurs within the DLT period from C1D1 of treatment with \[177Lu\]Lu-NeoB and capecitabine. The National Cancer Institute (NCI) CTCAE version 5.0 will be used for all grading.
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG [68Ga]Ga-NeoB
- DRUG [177Lu]Lu-NeoB
Study Locations (20)
Other
- Novartis Investigative Site - Guangzhou
- Novartis Investigative Site - Tianjin
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Grenoble
- Novartis Investigative Site - Saint-Herblain
- Novartis Investigative Site - Strasbourg
- Novartis Investigative Site - Villejuif
- Novartis Investigative Site - Erlangen
- Novartis Investigative Site - Essen
- Novartis Investigative Site - Tübingen
California
- UCLA Medical Center - Los Angeles
- Hoag Memorial Hospital Presbyterian - Newport Beach
Minnesota
- Mayo Clinic - Rochester - Rochester
Texas
- Uni Of TX MD Anderson Cancer Cntr - Houston
Wisconsin
- University Of Wisconsin - Madison
New South Wales
- Novartis Investigative Site - Darlinghurst
Victoria
- Novartis Investigative Site - Malvern
Ontario
- Novartis Investigative Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2024-08-14 |
| Est. Completion | 2031-09-09 |
| Phase | Phase 1 |
What NCT06247995 shows while recruiting
NCT06247995 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Capecitabine is the first listed.
NCT06247995 names 20 study sites across 10 states, led by Other, California, Minnesota.
Frequently Asked Questions
What is clinical trial NCT06247995 about?
NCT06247995 is a clinical study titled "A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.". In the phase I part, to determine the recommended doses (RD) and dosing regimens of \[177Lu\]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive, human epidermal growth factor receptor-2 negative metastatic breast ca...
What is the current status of trial NCT06247995?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2024-08-14. Estimated completion is 2031-09-09.
What conditions does trial NCT06247995 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT06247995?
The interventions under investigation include: Capecitabine (DRUG), [68Ga]Ga-NeoB (DRUG), [177Lu]Lu-NeoB (DRUG).
Who is sponsoring clinical trial NCT06247995?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06247995 being conducted?
This trial has 20 study locations across California, Minnesota, Texas, Wisconsin, New South Wales. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06247995's enrollment target sits among peer trials
58 761st of 1224 higher than 461 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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