Testing the Safety and Efficacy of the Addition of a New Anti-cancer Drug, ZEN003694, to Chemotherapy Treatment (Cisplatin and Etoposide or Carboplatin and Paclitaxel) for Adult and Pediatric Patients (12-17 Years) With NUT Carcinoma

Conditions

• Advanced NUT Carcinoma
• Metastatic NUT Carcinoma
• Unresectable NUT Carcinoma

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• BET Bromodomain Inhibitor ZEN-3694 — DRUG
  Given PO
• Biopsy Procedure — PROCEDURE
  Undergo biopsy
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Carboplatin — DRUG
  Given IV
• Cisplatin — DRUG
  Given IV
• Etoposide — DRUG
  Given IV
• Imaging Procedure — PROCEDURE
  Undergo imaging scans
• Paclitaxel — DRUG
  Given IV

Study Details

This phase I trial tests the safety, side effects, and best dose of ZEN003694 in combination with cisplatin and etoposide or carboplatin and paclitaxel in treating patients with NUT carcinoma. Another purpose of this study is to see whether there are any changes in patient's tumor or blood characteristics (e.g. genes, molecules, etc.) due to combination therapy. ZEN003694 inhibits the production of certain growth-promoting proteins and may prevent proliferation of tumor cells that use those proteins for their growth. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid (DNA) repair and may kill tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Combination therapy with ZEN003694 and etoposide and cisplatin or carboplatin and paclitaxel may be safe and effective in treating patients with NUT carcinoma.

Key Dates

Start date

Jul 13, 2022

Status verified

Jan 2026

Primary completion

Jun 30, 2026

Completion

Jun 30, 2026

Study Design

Enrollment

36 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cohort I (ZEN003694, etoposide, cisplatin)
  Patients receive ZEN003694 PO once or twice daily on days 1-14 or days 1-21 of each cycle depending upon dosage assignment. Patients also receive etoposide IV over 60 minutes on days 1-3 of each cycle and cisplatin IV over 60 minutes on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may then receive etoposide and cisplatin for an additional 4 cycles in the absence of disease progression or unacceptable toxicity, per the treating investigator's discretion. After completion of etoposide and cisplatin treatment, patients may then receive ZEN003694 PO once or twice daily on days 1-14 or 1-21 of each cycle, per the treating investigator's discretion. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo imaging scans, blood sample collection, and biopsies throughout the study.
• Experimental: Cohort II (ZEN003694, carboplatin, paclitaxel)
  Patients receive ZEN003694 PO once or twice daily on days 1-14 or days 1-21 of each cycle depending upon dosage assignment. Patients also receive carboplatin IV over 15-30 minutes on day 1 of each cycle and paclitaxel IV over 3 hours on day 1 of each cycle. Cycles repeat every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients may then receive carboplatin and paclitaxel for an additional 4 cycles in the absence of disease progression or unacceptable toxicity, per the treating investigator's discretion. After completion of carboplatin and paclitaxel treatment, patients may then receive ZEN003694 PO once or twice daily on days 1-14 or 1-21 of each cycle, per the treating investigator's discretion. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients also undergo imaging scans, blood sample collection, and biopsies throughout the study.
• Experimental: Cohort III (ZEN003694)
  Patients receive ZEN003694 PO on days 1-5, 8-12, and 15-19 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who experience disease progression have the option to cross-over to Cohort I and receive treatment for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Cross-over patients may then receive ZEN003694 PO on days 1-21 of each cycle in the absence of disease progression or unacceptable toxicity, per the treating investigator's discretion. Patients also undergo imaging scans, blood sample collection, and biopsies throughout the study.

Primary Outcome Measure

Maximum tolerated dose (MTD) (phase 1) [ Time Frame: Up to 21 days of each cycle ]

Locations (5)

Find similar trials in Los Angeles, CA

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