Comparing 3 approaches for advanced solid tumor

Exclusion

• −history of hypersensitivity to compounds of similar biological composition to IL-12, aluminum hydroxide, or drugs formulated with polysorbate-20
• −Part 3 only: hypersensitivity to cemiplimab or any of its excipients or contraindications to cemiplimab per approved local labeling
• −known history of hepatitis B virus, known active hepatitis C virus, or a positive serological test at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → within 28 days prior to the start of treatment
• −HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
• −injectable tumors impinging upon major airways or blood vessels
• −prior treatment with recombinant interleukin-12 (IL-12)
• −have received systemic therapy with immunosuppressive agents ≤ 28 days before the start of treatment
• −have received live vaccines within 28 days prior to the start of ANK-101 treatment
• −have primary or acquired immunodeficient states (e.g., leukemia, lymphoma)
• −prior organ transplantation
• −active autoimmune disease or medical conditions requiring chronic steroid (i.e., ≥ 20 mg/day prednisone or equivalent) or other immunosuppressive therapy within 28 days prior to the start of treatment
• −known active central nervous system (CNS) metastases
• −congestive heart failure (\> New York Heart Association Class II), active coronary artery disease, unevaluated new onset angina within 3 months or unstable angina (angina symptoms at rest), or clinically significant cardiac arrhythmias
• −uncontrolled bleeding disorders within 4 weeks prior to the start of treatment or known bleeding diathesis - Note: Part 2 only: Participants with active bleeding diathesis or requirement for therapeutic anticoagulation that cannot be interrupted or altered for procedures
• −other systemic conditions or organ abnormalities that, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, may interfere with the conduct and/or interpretation of the current study
• −any acute or chronic psychiatric problems or substance abuse disorder that, in the opinion of the Investigator, make the participant unsuitable for participation
• −Part 3 only: prior Grade 3 or greater immune-mediated adverse eventsAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → (imAEs) following treatment with an agent that blocks the programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) pathway.
• −a woman of childbearing potential (WOCBP) who has a positive serum pregnancy test (within 72 hours) prior to the start of treatment or female participant who is breastfeeding