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NCT05029999 · ClinicalTrials.gov registry record · Phase 1

CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer

A Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, sponsored by University of Texas Southwestern Medical Center.

Recruiting
Registry status
Phase 1
Development phase
30
Enrollment target
7
Study locations

NCT05029999 is a Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer that is actively recruiting participants, run by University of Texas Southwestern Medical Center. The registered enrollment target is 30 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 7 study locations across 5 states.

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The verdict

NCT05029999, a Phase 1 study of Metastatic Breast Cancer and HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by University of Texas Southwestern Medical Center.

RECRUITING
Registry status
Phase 1
Development phase
30 participants
Enrollment target
7
Study locations

Study Summary

This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.

Interventions

  • DRUG PLD Chemotherapy
  • DRUG CDX-1140
  • DRUG CDX-301

Study Locations (7)

Texas

  • Texas Oncology, P.A. - Dallas
  • UT Southwestern Medical Center - Dallas
  • The University of Texas Health Science Center at San Antonio - San Antonio

Illinois

  • University of Chicago Comprehensive Cancer Center - Chicago

Maryland

  • Johns Hopkins University - Baltimore

North Carolina

  • University of North Carolina - Chapel Hill

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-04-20
Est. Completion 2026-04-20
Phase Phase 1

What the Registry Record Tells You About NCT05029999

The ClinicalTrials.gov registry entry for NCT05029999 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (85% lower). The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which PLD Chemotherapy is the first listed.

NCT05029999 reports 7 study locations spanning 5 distinct geographic areas - top geographies include Texas, Illinois, Maryland.

Frequently Asked Questions

What is clinical trial NCT05029999 about?

NCT05029999 is a clinical study titled "CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer". This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epiderma...

What is the current status of trial NCT05029999?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2022-04-20. Estimated completion is 2026-04-20.

What conditions does trial NCT05029999 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer, HER2-Negative Breast Cancer.

What interventions are being tested in trial NCT05029999?

The interventions under investigation include: PLD Chemotherapy (DRUG), CDX-1140 (DRUG), CDX-301 (DRUG).

Who is sponsoring clinical trial NCT05029999?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05029999 being conducted?

This trial has 7 study locations across Illinois, Maryland, North Carolina, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.