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BET inhibitor
ZEN003694 for Squamous Cell Lung Cancer
Phase 2
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 • NCT0271195675%
Visual impairment
25%
Haematuria
25%
Fatigue
25%
Weight decreased
25%
Enterococcal bacteraemia
25%
Pathological fracture
100%
80%
60%
40%
20%
0%
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
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZEN003694
2016
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,873 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is below normal.I am taking medication that strongly affects liver enzymes.I am not using, nor plan to use, strong P-gp inhibitors 7 days before starting the study drug.I am taking oral blood thinners.I am not breastfeeding and will not be during the study.I have a heart condition or significant heart disease.I do not have any other cancer that needs treatment right now.I am not pregnant and agree to regular pregnancy tests during the study.I am 18 years old or older.I have a history of bleeding or clotting disorders, including current use of blood thinners.I am a male willing to use a condom if my partner can have children.I haven't had radiation therapy in the last 2 weeks.I haven't taken any cancer treatment or experimental drugs in the last 2 weeks.I have not had major surgery in the last 4 weeks.I am taking no more than 10 mg of prednisone or its equivalent daily.My blood tests are within the required ranges and I can swallow capsules.I do not have any major health issues that could affect my safety in the study.I have had brain metastases but don't need high doses of steroids.My cancer shows NSD3 gain or 8p11 amplification.I have not had a heart attack or unstable chest pain in the last 6 months.I have received platinum-based chemotherapy and immunotherapy as my first treatment.I can take care of myself and perform daily activities.My lung cancer is squamous cell type and has come back or spread.I am not able to become pregnant, or I use effective birth control methods.
Research Study Groups:
This trial has the following groups:- Group 1: ZEN003694
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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