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BET inhibitor

ZEN003694 for Squamous Cell Lung Cancer

Phase 2
Led By Paul Paik, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically-confirmed squamous cell lung cancer
Recurrent or metastatic disease
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is evaluating if a drug, ZEN003694, could be an effective treatment for advanced squamous cell lung cancer with a mutation in the NSD3 gene. It works by blocking proteins that may counter the effect of NSD3 on tumor growth.

Who is the study for?
Adults with advanced squamous cell lung cancer and NSD3 gene mutation can join this trial. They must have had prior chemotherapy and immunotherapy, be able to swallow capsules, and not be pregnant or breastfeeding. Stable brain metastases are okay. Participants need proper organ function, no recent heart attacks or surgeries, and cannot have HIV/HBV/HCV or other significant health issues.Check my eligibility
What is being tested?
The study is testing ZEN003694's effectiveness for squamous cell lung cancer with an NSD3 mutation. It's a BET inhibitor that may slow down tumor growth by blocking proteins involved in cancer progression.See study design
What are the potential side effects?
While the specific side effects of ZEN003694 aren't listed here, similar drugs often cause fatigue, nausea, rash, and liver enzyme changes. There could also be risks related to heart rhythm disturbances due to its potential effect on QT interval.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
My lung cancer is confirmed to be squamous cell type.
My cancer has returned or spread to other parts of my body.
I have treated brain metastases and take no more than 10mg of prednisone.
I've had platinum-based chemo and immunotherapy for my cancer.
I can take care of myself and perform daily activities.
My cancer has NSD3 amplification confirmed by a specific test.
I can swallow pills.
I am on a stable dose of corticosteroids not exceeding 10 mg of prednisone or its equivalent.
I am 18 years old or older.
I am a woman who cannot become pregnant, either because of menopause or being permanently sterile.
I use a reliable birth control method correctly every time.
I am a male willing to use a condom with partners who can get pregnant, from 21 days before until 4 months after my last dose.
I am able to bear children, have tested negative for pregnancy, and agree to regular pregnancy tests during the study.
I am not breastfeeding and will not breastfeed during the study or for 7 months after.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
overall response rate (ORR)

Side effects data

From 2019 Phase 1 & 2 trial • 75 Patients • NCT02711956
Visual impairment
Weight decreased
Enterococcal bacteraemia
Pathological fracture
Study treatment Arm
DE A+B 36 mg ZEN003694 + Enzalutamide
DE/DC A+B 48 mg ZEN003694 + Enzalutamide
DE A+B 60 mg ZEN003694 + Enzalutamide
DE A+B 72 mg ZEN003694 + Enzalutamide
DE/DC A+B 96 mg ZEN003694 + Enzalutamide
DE A+B 120 mg ZEN003694 + Enzalutamide
DE A+B 144 mg ZEN003694 + Enzalutamide

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ZEN003694Experimental Treatment1 Intervention
All patients enrolled on the study will undergo treatment with ZEN003694 60mg po qd on a 5 days on/2 days off schedule in an every 21-day cycle. All assessments, including drug dosing, have a window of +/- 7 days unless otherwise noted.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 2

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,920 Previous Clinical Trials
590,578 Total Patients Enrolled
Zenith EpigeneticsIndustry Sponsor
9 Previous Clinical Trials
587 Total Patients Enrolled
Paul Paik, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Media Library

ZEN003694 (BET inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05607108 — Phase 2
Squamous Cell Carcinoma Research Study Groups: ZEN003694
Squamous Cell Carcinoma Clinical Trial 2023: ZEN003694 Highlights & Side Effects. Trial Name: NCT05607108 — Phase 2
ZEN003694 (BET inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05607108 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients able to enroll in this clinical trial at this time?

"That is correct. The clinicaltrials.gov website provides evidence that this trial, which was first posted on November 1st, 2020, is still looking for participants. They are hoping to enrol 25 patients from 7 different hospitals or clinics."

Answered by AI

Is ZEN003694 dangerous for human beings?

"ZEN003694's safety is based on Phase 2 trial data, which only provides limited support. However, there is currently no efficacy data available."

Answered by AI

How many individuals are being given this medication as part of the trial?

"The information available on clinicaltrials.gov supports that this clinical trial is looking for new participants and is presently recruiting. The first posting was on November 1st, 2022 and there have been no updates since then. They are searching for a total of 25 people to participate across 7 sites."

Answered by AI

Are there a number of research facilities testing this hypothesis in Canada?

"7 sites are recruiting patients for this clinical trial, with Memorial Sloan Kettering Monmouth (All Protocol Activities) in Middletown, Memorial Sloan Kettering Nassau (All Protocol Activities) in Uniondale, and Memorial Sloan Kettering Bergen (All Protocol Activities) in Montvale being some of them."

Answered by AI
~14 spots leftby Nov 2025