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NCT05187832 · ClinicalTrials.gov registry record · Phase 1

A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer

A Phase 1 study of Advanced or Metastatic Breast Cancer, sponsored by Kind Pharmaceuticals.

Recruiting
Registry status
Phase 1
Development phase
61
Enrollment target
1
Study location

NCT05187832: Recruiting Phase 1 study of Advanced or Metastatic Breast Cancer, sponsored by Kind Pharmaceuticals.

NCT05187832 is a Phase 1 study of Advanced or Metastatic Breast Cancer that is actively recruiting participants, run by Kind Pharmaceuticals. The registered enrollment target is 61 participants, below the 404-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05187832, a Phase 1 study of Advanced or Metastatic Breast Cancer, is actively recruiting participants, sponsored by Kind Pharmaceuticals.

RECRUITING
Registry status
Phase 1
Development phase
61 participants
Enrollment target
1
Study location

Study Summary

This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal growth factor receptor 2 \[HER2\]-negative) breast cancer.

Primary Outcome

Number of participants with adverse events

Interventions

  • DRUG AND019 PO QD

Study Locations (1)

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2022-10-05
Est. Completion 2026-11
Phase Phase 1
Kind Pharmaceuticals

3 total trials

What NCT05187832 shows while recruiting

NCT05187832 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 404-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (85% lower).

The record links to 1 condition, with Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which AND019 PO QD is the first listed.

NCT05187832 reports a single indexed study location in Tennessee.

Frequently Asked Questions

What is clinical trial NCT05187832 about?

NCT05187832 is a clinical study titled "A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer". This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with advanced or metastatic estrogen receptor (ER)-positive (human epidermal g...

What is the current status of trial NCT05187832?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 61 participants. The study started on 2022-10-05. Estimated completion is 2026-11.

What conditions does trial NCT05187832 study?

This clinical trial studies the following conditions: Advanced or Metastatic Breast Cancer.

What interventions are being tested in trial NCT05187832?

The interventions under investigation include: AND019 PO QD (DRUG).

Who is sponsoring clinical trial NCT05187832?

This trial is sponsored by Kind Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05187832 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT05187832, the US trial registry maintained by the National Library of Medicine. NCT05187832 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.