A Study of ZEN003694 in People With Squamous Cell Lung Cancer

Inclusion Criteria

• •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
• •Eastern Cooperative Oncology Group (ECOG) PS 0-2
• •Evidence of NSD3 gain or amplification by NGS, including but not limited to evidence of 8p11 gain or amplification as determined by MSK IMPACT or MSK ACCESS, or a commercially available molecular assay that is FDA authorized. Note: ctDNA testing, including but not limited to MSK ACCESS and Guardant and Foundation
• •Adequate laboratory parameters at Screening including:
• •* Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
• •* Platelet count ≥ 100,000/mm\^3
• •* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.0 ULN (≤ 5 x ULN if liver metastases are present)
• •* Total bilirubin ≤ 1.25 x ULN
• •* Calculated or measured eGFR ≥ 40 ml/min or serum creatinine ≤ 1.5 x ULN
• •* Prothrombin time (PT), international normalized ratio (INR) and partial thromboplastin time (PTT) \< 1.5 x ULN
• •Ability to swallow capsules
• •Use of corticosteroids is allowed up to a daily dose of 10 mg prednisone or equivalent provided that the dose has been stable for at least 2 weeks prior to the start of ZEN003694 dosing and will remain stable during ZEN003694 treatment.
• •Females or males age ≥ 18 years (at time of signing informed consent)
• •Female subjects may be enrolled if they are not of childbearing potential, permanently sterile or who are post-menopausal defined as no menses for at least 1 year without an alternative medical cause and FSH levels in the post-menopausal range. Female subjects of childbearing potential may be enrolled if they consistently and correctly use a highly effective form of contraception. Highly effective forms of contraception include: combined (estrogen and progestogen hormonal contraceptives (oral, intravaginal, transdermal) associated with inhibition of ovulation; progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence. Female subjects should not donate eggs from the time point of study drug administration until at least 7 months thereafter.
• •Males with partners of childbearing potential may be enrolled if they use a condom when having sex with a pregnant woman or with a non-pregnant female of childbearing potential from 21 days before the first dose of study drug through 4 months after the last dose of study drug, and males should not donate sperm from the time point of study drug administration until at least 4 months thereafter.
• •Contraception should be considered for a non-pregnant female partner of childbearing potential
• •Females of childbearing potential must have a negative serum or urine pregnancy test before the first dose of study drugs and must agree to pregnancy tests during the study.
• •Females may not be breast-feeding at the first dose of study drugs, during study participation or through 7 months after the last dose of study drugs