Treating Advanced Breast Cancer or Other Solid Cancers Using a Combination of a New Targeted Therapy, ZEN003694, With The Targeted Therapy Abemaciclib (Verzenio)
https://www.facingourrisk.org/research-clinical-trials/study/363/testing-a-new-drug-zen003694-with-chemotherapy-abemaciclib-for-people-with-advanced-or-inoperable-breast-cancer-and-other-solid-tumors
Clinicaltrials.gov identifier:
NCT05372640 (https://clinicaltrials.gov/show/NCT05372640)
Treatment
Phase 1 treatment study for advanced breast cancer and other solid tumors
Study Contact Information:
Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below.
About the Study
This clinical trial is studying whether the combination of two targeted therapies, abemaciclib (Verzenio) and a new targeted therapy ZEN003694 (also known as ZEN-3694) can be given together safely and what dose should be used in future studies.
Both drugs are a type of targeted therapy that blocks pathways in cancer cells to slow tumor growth.
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ZEN003694 is a type of targeted therapy known as a BET inhibitor. The drug is currently used to treat a very rare type of cancer known as an NUT carcinoma.
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Abemaciclib is a targeted therapy known as a CDK4/6 inhibitor. Abemaciclib is currently used for treating breast cancer.
Researchers want to gather information about whether this drug combination may help shrink or control cancer in people whose tumors have spread or cannot be removed by surgery.
This Phase 1 clinical trial focuses first on safety and side effects and determining the best dose for future studies.
What the Study Involves
If a person joins this trial:
- They will receive both drugs daily by mouth (oral medication) in repeated treatment cycles.
- Treatment continues in 28-day cycles as long as it is safe and the cancer has not progressed.
- While on the study, participants will have blood tests, imaging scans (like CT or MRI), and tumor biopsies to monitor how the drugs act and how the cancer responds.
- After stopping treatment, participants are followed for check-ins every 3 months for two years, followed by every 6 months for three years to monitor long-term safety and outcomes.
This Study is Open To:
People with the following may be eligible:
- advanced or metastatic triple-negative breast cancer or advanced solid tumors that have spread (metastatic) or cannot be surgically removed (unresectable), including NUT carcinoma.
- people whose disease cannot be cured or controlled with standard treatments or for whom standard options are no longer effective.
This Study is Not Open To:
People cannot join the study if they:
- are under 12 years of age.
- are diagnosed with a cancer that can be treated effectively with standard therapies.
- have a serious uncontrolled medical conditions that could interfere with study treatment or safety.
- are pregnant.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.