A Study of ZEN003694 in People With Squamous Cell Lung Cancer
ConditionSquamous Cell Lung Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically-confirmed squamous cell lung cancer
Recurrent or metastatic disease
Patients with previously treated asymptomatic brain metastases requiring no more than 10mg prednisone (or equivalent) are allowed. Patients with asymptomatic brain metastases ≤ 1cm not requiring more than 10mg prednisone (or equivalent) are allowed.
Received prior first-line therapy: platinum-based chemotherapy and immunotherapy, given either concurrently or sequentially
Disqualifiers
Have previously received an investigational BET inhibitor
Have received prior systemic anti-cancer therapy or investigational therapy within 2 weeks or five half-lives, whichever is shorter, prior to the first dose of study drug
Radiation therapy within 2 weeks of first dose of study drug
Currently receiving medications known to be strong inducers or inhibitors of CYP3A4 and substrates of CYP1A2 with a narrow therapeutic window. Strong inducers and inhibitors of CYP3A4 and CYP1A2 substrates with narrow therapeutic ranges must be discontinued at least 7 days prior to the first administration of study drug.
Trial design
Design model
Single group
Treatments tested in this trial
ZEN003694
DrugZEN003694 60mg po qd on a 5 days on 2 days off schedule in an every 21-day cycle
Treatment groups
13 Participants
are divided into 1 treatment groupGroup A: ZEN003694Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
overall response rate (ORR)
Response to ZEN003694 will be determined using the sum unidimensional measurements of the target lesions present on the scan. Unidimensional measurement rules will adhere to RECIST 1.1 guidelines.(6) Classification of response will be categorized by RECIST 1.1 (CR, PR, SD, PD).
Time frame
2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Memorial Sloan Kettering Cancer Center
Lead sponsor
Zenith Epigenetics
Collaborator
Source ClinicalTrials.gov