Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05607108

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-03-11

13

Participants Needed

7

Research Sites

260 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Z

Zenith Epigenetics

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to find out whether ZEN003694 is an effective treatment for people with advanced squamous cell lung cancer with a mutation in the NSD3 gene. ZEN003694 is a type of drug called a BET inhibitor. Researchers think ZEN003694 may help here because the drug works by blocking a group of proteins called bromodomain and extra-terminal (BET) proteins, which may counteract the effect of NSD3 on tumor growth. Blocking these proteins may slow or stop the growth of the cancer.

CONDITIONS

Official Title

A Study of ZEN003694 in People With Squamous Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed squamous cell lung cancer
  • Recurrent or metastatic disease
  • Patients with previously treated asymptomatic brain metastases requiring no more than 10 mg prednisone or equivalent
  • Received prior first-line therapy with platinum-based chemotherapy and immunotherapy
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Evidence of NSD3 gene gain or amplification by FDA-authorized molecular assays
  • Adequate laboratory parameters including ANC ≥ 1.5 x 10^9/L, platelet count ≥ 100,000/mm^3, AST or ALT ≤ 2.0 ULN (≤ 5 ULN if liver metastases present), total bilirubin ≤ 1.25 ULN, eGFR ≥ 40 ml/min or serum creatinine ≤ 1.5 x ULN, and coagulation tests < 1.5 x ULN
  • Ability to swallow capsules
  • Use of corticosteroids up to 10 mg prednisone or equivalent daily with stable dose for at least 2 weeks prior to dosing
  • Age 18 years or older at the time of informed consent
  • Female subjects must be not of childbearing potential, permanently sterile, post-menopausal, or use highly effective contraception if of childbearing potential
  • Males with partners of childbearing potential must use condoms during and after treatment as specified
  • Negative pregnancy test before first dose and agreement to pregnancy testing during study
  • Females must not be breastfeeding at first dose or during study and for 7 months after last dose
Not Eligible

You will not qualify if you...

  • Prior treatment with investigational BET inhibitors
  • Systemic anti-cancer or investigational therapy within 2 weeks or five half-lives before first dose
  • Radiation therapy within 2 weeks before first dose
  • Use of strong CYP3A4 inducers or inhibitors and CYP1A2 substrates with narrow therapeutic window within 7 days before first dose
  • Left ventricular ejection fraction below 50% or institution's lower normal limit
  • QTcF interval greater than 470 milliseconds
  • Known impaired cardiac function or significant cardiac disease like uncontrolled arrhythmia or heart failure (NYHA class III or IV)
  • Myocardial infarction or unstable angina within 6 months before first dose
  • Other significant co-morbidities such as uncontrolled lung disease, active CNS disease, or infections requiring systemic therapy
  • Other active cancer requiring treatment at study entry
  • Positive history or active infection with HIV, hepatitis B or C
  • Major surgery other than minor procedures within 4 weeks before first dose
  • History of platelet function deficiency or coagulopathy, or current anticoagulation therapy except low-dose warfarin for port patency
  • Use of strong P-gp inhibitors within 7 days before first dose or during study
  • Use of oral Factor Xa or Factor IIa inhibitors; low molecular weight heparin allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 7 locations

1

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

2

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

3

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

4

Memorial Sloan Kettering Suffolk-Commack (All Protocol Activities )

Commack, New York, United States, 11725

Actively Recruiting

5

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

6

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

7

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

P

Paul Paik, MD

CONTACT

M

Mark Kris, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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