ZEN003694 for Squamous cell carcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Squamous cell carcinoma+1 More
ZEN003694 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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.

Eligible Conditions
  • Squamous cell carcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 2 years

2 years
overall response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

DE A+B 72 mg ZEN003694 + Enzalutamide
100%Visual impairment
50%Nausea
33%Thrombocytopenia
33%Fatigue
17%Haematuria
17%Spinal cord compression
17%Diarrhea
17%Dizziness
17%Decreased appetite
17%Taste disorder
17%Weight decreased
This histogram enumerates side effects from a completed 2019 Phase 1 & 2 trial (NCT02711956) in the DE A+B 72 mg ZEN003694 + Enzalutamide ARM group. Side effects include: Visual impairment with 100%, Nausea with 50%, Thrombocytopenia with 33%, Fatigue with 33%, Haematuria with 17%.

Trial Design

1 Treatment Group

ZEN003694
1 of 1

Experimental Treatment

25 Total Participants · 1 Treatment Group

Primary Treatment: ZEN003694 · No Placebo Group · Phase 2

ZEN003694
Drug
Experimental Group · 1 Intervention: ZEN003694 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZEN003694
2016
Completed Phase 2
~120

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years

Who is running the clinical trial?

Zenith EpigeneticsIndustry Sponsor
8 Previous Clinical Trials
625 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,821 Previous Clinical Trials
584,294 Total Patients Enrolled
Paul Paik, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
100 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have received prior first-line therapy.
You have a total bilirubin level of at least 1.25 times the upper limit of normal.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: November 11th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.