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NCT06120283 · ClinicalTrials.gov registry record · Phase 1

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

A Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, sponsored by BeiGene.

Recruiting
Registry status
Phase 1
Development phase
300
Enrollment target
20
Study locations

NCT06120283 is a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor that is actively recruiting participants, run by BeiGene. The registered enrollment target is 300 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (54% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT06120283, a Phase 1 study of Non-Small Cell Lung Cancer and Advanced Solid Tumor, is actively recruiting participants, sponsored by BeiGene.

RECRUITING
Registry status
Phase 1
Development phase
300 participants
Enrollment target
20
Study locations

Study Summary

This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) breast cancer (BC) and other advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-43395.

Conditions Studied

Non-Small Cell Lung Cancer Advanced Solid Tumor Metastatic Breast Cancer HER2-Negative Breast Cancer Advanced Breast Cancer Hormone Receptor-Positive Breast Cancer Hormone Receptor-Positive Breast Carcinoma Hormone Receptor Positive HER-2 Negative Breast Cancer Hormone Receptor Positive Malignant Neoplasm of Breast

Interventions

  • DRUG Letrozole
  • DRUG Fulvestrant
  • DRUG BGB-43395
  • DRUG Elacestrant

Study Locations (20)

New South Wales

  • Blacktown Cancer and Haematology Centre - Blacktown
  • Southern Highlands Private Hospital - Bowral
  • Concord Repatriation General Hospital - Concord
  • Macquarie University - North Ryde

Texas

  • The University of Texas Md Anderson Cancer Center - Houston
  • Next Dallas - Irving
  • Next Oncology - San Antonio

Victoria

  • Austin Health - Heidelberg
  • Peter Maccallum Cancer Centre - Melbourne

Other

  • Fundacao Pio Xii Hospital de Amor de Barretos - Barretos
  • Hospital Sirio Libanes Brasilia - Brasília

Colorado

  • Sarah Cannon Research Institute (Scri) At Health One - Denver

Florida

  • Florida Cancer Specialists and Research Institute - Lake Mary

Michigan

  • Karmanos Cancer Institute - Detroit

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-12-01
Est. Completion 2028-06
Phase Phase 1

Sponsor

BeiGene

65 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06120283

The ClinicalTrials.gov registry entry for NCT06120283 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (54% lower). The listed sponsor is BeiGene, which has 65 total studies on file at ClinicalTrials.gov.

The record links to 9 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole is the first listed.

NCT06120283 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New South Wales, Texas, Victoria.

Frequently Asked Questions

What is clinical trial NCT06120283 about?

NCT06120283 is a clinical study titled "BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors". This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growth...

What is the current status of trial NCT06120283?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 300 participants. The study started on 2023-12-01. Estimated completion is 2028-06.

What conditions does trial NCT06120283 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Breast Cancer, HER2-Negative Breast Cancer, Advanced Breast Cancer.

What interventions are being tested in trial NCT06120283?

The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), BGB-43395 (DRUG), Elacestrant (DRUG).

Who is sponsoring clinical trial NCT06120283?

This trial is sponsored by BeiGene, which has 65 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06120283 being conducted?

This trial has 20 study locations across Colorado, Florida, Michigan, Missouri, North Carolina. 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.