Purpose of this Study
We are doing this study to find out if an experimental drug called BGB-43395 (the study drug) is a safe and effective option for people with for breast cancer and other advanced solid tumors. We want to know how the study drug works on its own and in combination with other cancer drugs.
Who Can Participate?
Eligibility
Adults ages 18+ who are diagnosed with advanced solid tumors and one of the following types of cancer:<ul>
<li>Head and neck squamous cell carcinoma (HNSCC)</li>
<li>Melanoma</li>
<li>Non-small cell lung cancer (NSCLC)</li>
<li>Colorectal cancer</li>
<li>Gastric cancer</li>
<li>Esophageal cancer</li>
<li>Liposarcoma</li>
<li>Renal cell carcinoma</li>
<li>Cutaneous squamous cell carcinoma</li>
<li>Prostate cancer</li>
<li>Ewing's sarcoma</li>
<li>Familial melanoma</li>
<li>Adrenocortical carcinoma</li>
<li>Ovarian cancer</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: joanna.gontarz@duke.edu">joanna.gontarz@duke.edu.</a>
<li>Head and neck squamous cell carcinoma (HNSCC)</li>
<li>Melanoma</li>
<li>Non-small cell lung cancer (NSCLC)</li>
<li>Colorectal cancer</li>
<li>Gastric cancer</li>
<li>Esophageal cancer</li>
<li>Liposarcoma</li>
<li>Renal cell carcinoma</li>
<li>Cutaneous squamous cell carcinoma</li>
<li>Prostate cancer</li>
<li>Ewing's sarcoma</li>
<li>Familial melanoma</li>
<li>Adrenocortical carcinoma</li>
<li>Ovarian cancer</li></ul>
For more information about who can join this study, please contact the study team at <a href= "mailto: joanna.gontarz@duke.edu">joanna.gontarz@duke.edu.</a>
What is Involved?
If you choose to join this study, you will participate in 1 of 3 parts to the study. The part of the study in which you participate will depend on when you join the study.
If you join the study during Part A (monotherapy), you will be treated with the study drug alone.
If you join the study during Part B (combination therapy), you will be treated with the study drug in combination with fulvestrant.
If you join the study during Part C (combination therapy), you will be treated with the study drug in combination with letrozole.
Before you begin taking the study regimen, there is a screening process to confirm your eligibility to join the study. During this screening, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li>
<li>Have imaging (CT/MRI/PET)</li>
<li>Have an endoscopy</li>
<li>Give urine samples</li></ul>
If you are eligible to continue in the study after screening, you will begin taking the study regimen according to the part of the study in which you are enrolled.<ul>
<li>Everyone in Parts A, B, and C will take the study drug by mouth twice a day in the morning and evening.</li>
<li>Participants in Part B will also get an injection of fulvestrant on the 1st and 15th days of their study regimen, and then every 4 weeks thereafter.</li>
<li>Participants in Part C will also take letrozole by mouth once each day.</li></ul>
If you join the study during Part A (monotherapy), you will be treated with the study drug alone.
If you join the study during Part B (combination therapy), you will be treated with the study drug in combination with fulvestrant.
If you join the study during Part C (combination therapy), you will be treated with the study drug in combination with letrozole.
Before you begin taking the study regimen, there is a screening process to confirm your eligibility to join the study. During this screening, you will:<ul>
<li>Have a physical exam</li>
<li>Have a heart scan (ECG)</li>
<li>Have blood draws</li>
<li>Have a tumor biopsy</li>
<li>Have imaging (CT/MRI/PET)</li>
<li>Have an endoscopy</li>
<li>Give urine samples</li></ul>
If you are eligible to continue in the study after screening, you will begin taking the study regimen according to the part of the study in which you are enrolled.<ul>
<li>Everyone in Parts A, B, and C will take the study drug by mouth twice a day in the morning and evening.</li>
<li>Participants in Part B will also get an injection of fulvestrant on the 1st and 15th days of their study regimen, and then every 4 weeks thereafter.</li>
<li>Participants in Part C will also take letrozole by mouth once each day.</li></ul>
Study Details
Full Title
A Phase 1a/1b Study Investigating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of the CDK4 Inhibitor BGB-43395, Alone or as Part of Combination Therapies in Patients With Metastatic HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Principal Investigator
Carey
Anders
Protocol Number
PRO00114226
NCT ID
NCT06120283
Phase
I
Enrollment Status
Open to Enrollment