Testing a New Drug, ZEN003694, With Chemotherapy (Abemaciclib), for People With Advanced or Inoperable Breast Cancer and Other Solid Tumors
Treatment
Phase 1 treatment trial enrolling people aged 12 years and older with metastatic or unresectable (cannot be removed by surgery) breast cancer and other solid tumors
Clinicaltrials.gov identifier:NCT05372640
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 investigational drugs — ZEN003694 (also known as ZEN-3694) and abemaciclib — can be given safely together and what dose should be used in future trials.
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ZEN003694 is an experimental drug that targets proteins involved in cancer cell growth.
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Abemaciclib is a drug that may slow cancer cell division by blocking key enzymes involved in cell growth.
Researchers also want to gather early 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 trial focuses first on safety and side effects and determining the best dose for future studies.
This Study is Open To:
This study is open to:
- People aged 12 years and older.
- People with advanced that have spread () 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:
This study is not open to:
- People under 12 years of age.
- People with cancers that can be treated effectively with standard therapies.
- People who have serious uncontrolled medical conditions that could interfere with study treatment or safety.
- People who are pregnant.
What the Study Involves
If a person joins this trial:
- They will receive both drugs 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 ), and tumor biopsies to monitor how the drugs act and how the cancer responds.
- After stopping treatment, participants are followed for regular check-ins for several years to monitor long-term safety and outcomes.
Study Contact Information:
Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below.
Locations:
California
City: Los Angeles RECRUITING
Facility: Keck Medicine of USC Koreatown
Contact Info:
213-388-0908
Robert Hsu
City: Los Angeles RECRUITING
Facility: Los Angeles General Medical Center
Contact Info:
[email protected]
323-865-0451
Robert Hsu
City: Los Angeles RECRUITING
Facility: USC / Norris Comprehensive Cancer Center
Contact Info:
323-865-0451
Robert Hsu
City: Newport Beach RECRUITING
Facility: USC Norris Oncology/Hematology-Newport Beach
Contact Info:
323-865-0451
Robert Hsu
Massachusetts
City: Boston RECRUITING
Facility: Dana-Farber Cancer Institute
Contact Info:
877-442-3324
Jia Luo
Pennsylvania
City: Pittsburgh RECRUITING
Facility: University of Pittsburgh Cancer Institute (UPCI)
Contact Info:
412-647-8073
Liza C. Villaruz
Texas
City: Houston RECRUITING
Facility: M D Anderson Cancer Center
Contact Info:
[email protected]
877-632-6789
Sarina A. Piha-Paul
Treatment
Phase 1 treatment trial enrolling people aged 12 years and older with metastatic or unresectable (cannot be removed by surgery) breast cancer and other solid tumors
Clinicaltrials.gov identifier:NCT05372640
Study Contact Information:
Please reach out to the individual contact at the study site you wish to enroll in. See the locations section below.