BGB-43395 for Advanced Breast Cancer and Other Tumors

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

Recruiting Phase 1 Interventional Study
Advanced Solid Tumor Advanced Breast Cancer Metastatic Breast Cancer Hormone-receptor-positive Breast Cancer Hormone Receptor Positive Breast Carcinoma Hormone Receptor Positive Malignant Neoplasm of Breast HER2-negative Breast Cancer Hormone Receptor Positive HER-2 Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
433 (estimated)
Sponsor
BeOne Medicines · Industry
Who this trial is looking for

This trial is looking for women with advanced breast cancer or other solid tumors. Participants will take a new drug called BGB-43395 alone or with other treatments to find the best dose.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with advanced, metastatic, or unresectable solid tumors.
  • I have hormone receptor positive breast cancer.
  • I have received prior treatment for my advanced or metastatic cancer.
  • I am a postmenopausal woman or I am receiving treatment to suppress ovarian function.
  • I have stable health and my performance status is 1 or less.
  • I have good organ function.

You may not be able to join if

  • I have untreated brain metastases or leptomeningeal disease.
  • I have had any other cancer in the past 3 years, except certain skin cancers.
  • I have uncontrolled diabetes.
  • I have had an infection that required treatment in the past 28 days.
  • I have untreated chronic hepatitis B or active hepatitis C.
  • I have had an organ transplant.
  • I have had a stem cell transplant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

Check Your Eligibility
About This Trial
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 t…
Trial Locations
Loading…

Loading trial locations…

Eligibility Criteria
Inclusion Criteria: * Phase 1a (Dose Escalation): Participants with histologically or cytologically confirmed advanced, metastatic, or unresectable solid tumors associated with dependency on CDK4, including HR+ breast cancer, ovarian cancer, endometrial cancer, non-small cell lung cancer, and other…
Contacts

Study Director

1.877.828.5568

clinicaltrials@beonemed.com

CONTACT