Principal Investigator:
Study sponsor: Synthekine, Inc.
Location: HealthPartners Cancer Center at Regions Hospital, HealthPartners Frauenshuh Cancer Center
Phase of Study: I
Purpose of study: The purpose of this study is to test the safety and tolerability of the study drug STK-012 as a single drug, or in combination with other therapy. The drug works by helping to trigger the body’s immune system to attack the cancer cells, and destroying the cells so that they can’t multiply and divide.
Inclusion Criteria:
– Must be at least 18 years or older.
– Life expectancy of at least 3 months as determined by the treating physician.
– Must have measurable disease via RECIST 1.1.
– ECOG of 0 – 1.
– Adequate organ function as determined by local lab tests within 28 prior to first dose.
– Female patients of childbearing potential must have a negative serum pregnancy test within 72hrs prior to first dose of study drug, and must also agree to highly effective birth control methods during treatment, and for at least 180 days post last dose unless meeting the following criteria: Over the age of 60, postmenopausal with no menses for 1 year, and confirmed by FSH, history of hysterectomy and/or bilateral oophorectomy, or a history of bilateral tubal ligation.
– Male patients must also agree to highly effective methods of contraception and refrain from donating sperm during treatment, and for 180 days after the last dose.
– Patients must have adequate archival tissue within 24 months of screening. If archival tissue is not available, a fresh biopsy is required (unless deemed unsafe by the treating physician and discussion with the study medical monitor).
– Must have confirmed Stage IV non-squamous non small cell lung cancer.
– Patient’s tumor must be predominantly non-squamous histology. If small cell elements are present, patient will be ineligible.
– Must not have any known actionable gene mutations for which there are approved targeted therapies.
– Subjects in part E can have any level of PD-L1 expression (TPS of 0-100%), subjects in part F must have negative PD-L1 (TPS<1%) per local testing.
– Must not have received prior treatment for advanced NSQ NSCLC (Subjects that received adjuvant, neoadjuvant, or consolidation therapy are eligible for the study if the therapy was completed at least 12 months prior to recurrence or progression).
*Additional inclusion criteria may apply and will be discussed with the physician and research team*
Exclusion Criteria:
– Received systemic anticancer therapy within 3 weeks prior to first dose.
– Received radiation therapy within 2 weeks prior to first dose.
– Received prior treatment with IL-2 or IL-15 based cytokine therapy.
– Has history of pulmonary fibrosis (including pneumonitis), drug or radiation induced pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest CT.
– Currently participating in, or has participated in a study of an investigational agent or investigational device within 4 weeks prior to first dose of study drug. Subjects that entered a follow-up phase of an investigational study may participate if at least 4 weeks has passed since the last dose of previous treatment.
– Has received prior therapy with anti-PD1 or anti-PD-L1 agent, or agent directed to other receptors (such as CTLA-4, OX40, or CD137).
– Failure to recover from immune-related adverse event from previous immunotherapy. (Patients with sensory neuropathy, alopecia, or endocrinopathies that are controlled by hormone-replacement therapy, or other grade 2 or less event that in the physician’s opinion does not pose a safety risk to the patient, are eligible).
– Failure to recover from other non-immune-related toxicities from prior therapy to at least grade 2 or less.
– Known active brain mets. Patients with treated brain mets may be eligible if they are clinically stale and without need of steroid treatment for at least 14 days prior to first dose of study drug.
– Hypersensitivity of Grade 3 or higher to monoclonal antibodies, including pembrolizumab or any of its excipients.
– Known history or, or active autoimmune disease or syndrome that requires steroids or immunosuppressive agents. (patients with Vitiligo, type 1 diabetes mellitus, resolved childhood asthma, hypo- or hyperthyroidism due to autoimmune condition that doesn’t require immunosuppressive treatment, psoriasis, atopic dermatitis, or other skin condition that is managed without systemic therapy, or arthritis that is managed without systemic therapy beyond oral acetaminophen and NSAIDs are allowed).
– History of allogenic/solid tissue organ transplant.
– Clinically significant cardiovascular disease or risk factors at screening that include the following: cerebral vascular accident/stroke, or myocardial infarction, unstable angina, congestive heart failure (>/=NYHA class 2), or serious cardiac arrhythmia requiring medication. QTcF>470 on screening ECG, or congenital long QT syndrome. TdP, including hypokalemia or hypomagnesemia, history of significant or symptomatic bradycardia. Family history of sudden death or congenital long QT syndrome. Concomitant medications with known risk of Torsades De Pointe that cannot be discontinued or replaced with safe alternative within 6 half-lives before first dose of study drug.
– History of other clinically unstable/uncontrolled disorder, condition, or disease, that in the opinion of the physician, would pose a risk to patient safety, or interfere with the study evaluations, procedures, or completion.
– Serious active bacterial, viral, parasitic, or systemic fungal infections requiring systemic treatment within 30 days prior to first dose of study drug.
– Known additional malignancy that is progressing, or has required active treatment within the last 2 years (Patients with basal cell, squamous cell skin cancer, or carcinoma in situ that has undergone curative therapy are not excluded from being able to participate in the study).
– Has received a live-virus vaccine within the last 30 days prior to first dose of study drug (Seasonal flu and covid-19 vaccines that do not include live virus are permitted).
– Known history of testing positive for HIV or AIDS, or testing positive for HIV by positive serum HIV test at screening.
– Active hepatitis B or C infection at screening as confirmed by local lab tests.
– Pregnant, breastfeeding, expecting to conceive, or to father children within the duration of the study, starting at screening and through 180 days after the last dose of study drug.
*Additional criteria may apply and will be discussed with the physician and research team*
Study Contact:
Lisa Wahowske
(651) 254-1517
lisa.wahowske@parknicollet.com
