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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 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.

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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).

Conditions Studied

Breast Cancer

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

FieldValue
Enrollment Target 58 participants
Start Date 2024-08-14
Est. Completion 2031-09-09
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06247995

The ClinicalTrials.gov registry entry for NCT06247995 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.