National Cancer Institute (NCI)
This phase I trial tests the safety, side effects, and best dose of a ZEN003694 when given together with abemaciclib in treating patients with NUT carcinoma, breast cancer or other solid tumors that have spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (unresectable). ZEN003694 is an inhibitor of a family of proteins called the bromodomain and extra-terminal (BET). It may prevent the growth of tumor cells that overproduce BET protein. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving ZEN003694 and abemaciclib may help shrink or stabilize cancer in patients with NUT carcinoma, breast cancer or other solid tumors.
Breast Carcinoma
Malignant Solid Neoplasm
NUT Carcinoma
Abemaciclib
BET Bromodomain Inhibitor ZEN-3694
Biopsy
Biospecimen Collection
Diagnostic Imaging
Phase 1
PRIMARY OBJECTIVE: I. Determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of the combination of BET bromodomain inhibitor ZEN-3694 (ZEN003694) and abemaciclib. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. Determine the preliminary rates of progression-free survival (PFS), overall survival (OS), overall response rate (ORR), time to response (TTR) and duration of response (DoR) for the combination of ZEN003694 and abemaciclib in participants utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. III. Evaluate the pharmacokinetic (PK) profile of the combination. EXPLORATORY OBJECTIVE: I. Explore potential biomarker indicators of response and resistance in tumor tissue and blood samples. OUTLINE: This is a dose-escalation study of BET bromodomain inhibitor ZEN-3694 followed by a dose expansion study. Patients receive ZEN003694 orally (PO) once daily (QD) on days 1-28 or 5 days on and 2 days off, and abemaciclib PO twice daily (BID) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo imaging evaluation, blood sample collection and tumor biopsy throughout the study. After completion of study treatment, patients are followed up for 30 days, every 3 months for 2 years, and then every 6 months for 3 years.}}
Study Type : | Interventional |
Estimated Enrollment : | 30 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Phase 1 Study of BET Bromodomain Inhibitor ZEN003694 in Combination With the CDK4/6 Inhibitor Abemaciclib in Patients With NUT Carcinoma, Breast Cancer and Other Solid Tumors |
Actual Study Start Date : | August 10, 2023 |
Estimated Primary Completion Date : | June 1, 2025 |
Estimated Study Completion Date : | June 1, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment (ZEN003694, abemaciclib) Patients receive ZEN003694 PO QD on days 1-28 or 5 days on and 2 days off, and abemaciclib PO BID on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo imaging evaluation, blood sample collection and tumor biopsy throughout the study. |
Drug: Abemaciclib Drug: BET Bromodomain Inhibitor ZEN-3694 Procedure: Biopsy Procedure: Biospecimen Collection Procedure: Diagnostic Imaging |
Ages Eligible for Study: | 12 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Recruiting
Keck Medicine of USC Koreatown
The Angels, California, United States, 90020
Recruiting
Los Angeles General Medical Center
The Angels, California, United States, 90033
Recruiting
USC / Norris Comprehensive Cancer Center
The Angels, California, United States, 90033
Recruiting
USC Norris Oncology/Hematology-Newport Beach
Newport Beach, California, United States, 92663
Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Recruiting
M D Anderson Cancer Center
Houston, Texas, United States, 77030