Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Part of paid clinical trials in Los Angeles, California.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT05372640
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Anatomic Stage III Breast Cancer AJCC v8
  • Anatomic Stage IV Breast Cancer AJCC v8
  • Metastatic Breast Carcinoma
  • Metastatic Malignant Solid Neoplasm
  • Metastatic NUT Carcinoma
  • Unresectable Breast Carcinoma
  • Unresectable Malignant Solid Neoplasm
  • Unresectable NUT Carcinoma

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • BET Bromodomain Inhibitor ZEN-3694 — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Diagnostic Imaging Testing — PROCEDURE
    Undergo imaging evaluation

Study Details

This phase I trial tests the safety, side effects, and best dose of 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.

Key Dates

Start date
Aug 10, 2023
Status verified
Jun 2026
Primary completion
Jun 7, 2027
Completion
Jun 7, 2027

Study Design

Enrollment
45 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ZEN003694, abemaciclib)
    Patients receive ZEN003694 PO QD on days 1-28 or 5 days on and 2 days off of each cycle, 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.

Primary Outcome Measure

Maximum tolerated dose or recommended phase 2 dose (Phase I dose escalation) [ Time Frame: During the first cycle of therapy (28 days) ]

Locations (7)

FacilityCityStateZIPSite coordinators
Keck Medicine of USC KoreatownLos AngelesCalifornia90020
Site Public Contact
213-388-0908
Robert Hsu (PRINCIPAL_INVESTIGATOR)
Los Angeles General Medical CenterLos AngelesCalifornia90033
Site Public Contact
[email protected]
323-865-0451
Robert Hsu (PRINCIPAL_INVESTIGATOR)
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
Site Public Contact
323-865-0451
Robert Hsu (PRINCIPAL_INVESTIGATOR)
USC Norris Oncology/Hematology-Newport BeachNewport BeachCalifornia92663
Site Public Contact
323-865-0451
Robert Hsu (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Site Public Contact
877-442-3324
Jia Luo (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232
Site Public Contact
412-647-8073
Liza C. Villaruz (PRINCIPAL_INVESTIGATOR)
M D Anderson Cancer CenterHoustonTexas77030
Site Public Contact
[email protected]
877-632-6789
Sarina A. Piha-Paul (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
Keck Medicine of USC Koreatown· Los Angeles, CALos Angeles General Medical Center· Los Angeles, CAUSC / Norris Comprehensive Cancer Center· Los Angeles, CAUSC Norris Oncology/Hematology-Newport Beach· Newport Beach, CADana-Farber Cancer Institute· Boston, MAUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PA

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