Dr. Marcus Butler
Inclusion Criteria:
- ≥ 18 years of age on day of signing informed consent
- histologically or cytologically confirmed diagnosis of cutaneous, subcutaneous, soft
tissue, or nodal advanced solid tumor malignancy; metastatic disease eligible
- measurable disease per RECIST v1.1 - Note: Must have at least 1 tumor lesion with
longest dimension of ≥ 10 mm (≥ 15 mm for the short axis for malignant lymph node
lesions) that - For Part 1 only: can be easily palpated or detected by ultrasound to
facilitate IT injection of ANK-101 (i.e., tumor in skin, muscle, subcutaneous
tissue, or accessible lymph node) or; - For Part 2 only: can be accessed by
interventional radiologic or endoscopic procedures for injection (e.g., ultrasound
or computed tomography [CT] guided). - For Part 2 Dose Expansion Cohort only:
Histologically confirmed Stage III or Stage IV NSCLC
- Part 3 CSCC Combination Cohort: Histologically confirmed high-risk locally advanced
or metastatic CSCC not amenable to surgical management as determined by a
multidisciplinary tumor board.
- documented disease progression, be refractory to, or intolerant of existing SOC
therapy(ies) known to provide clinical benefit (including surgical cure) or not be
eligible for SOC therapy(ies)
- ECOG performance status 0-1
- life expectancy > 12 weeks
- adequate bone marrow, hepatic and renal function
- baseline electrocardiogram (EKG) without evidence of acute ischemia or prolonged QTc
interval > 460 msec
- Human immunodeficiency virus (HIV) infected participants must be on anti-retroviral
therapy (ART) and have well-controlled HIV infection/disease
- last dose of previous anticancer therapy (including investigational agents) ≥ 28
days, radiotherapy ≥ 14 days (targeted palliative radiotherapy is allowed for
lesions not planned for injections), or surgical intervention ≥ 21 days prior to the
start of treatment
- resolution of all prior anticancer therapy toxicities (except for alopecia or
vitiligo) to ≤ Grade 1 (as per NCI CTCAE Version 5.0)
- willing to provide pre- and post-treatment tumor biopsy samples if medically
feasible
- participant is capable of understanding and complying with protocol requirements
Exclusion Criteria:
- 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)
- 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
- prior organ transplantation
- known history of hepatitis B virus, known active hepatitis C virus, or a positive
serological test at screening within 28 days prior to the start of treatment
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric
Castleman Disease
- 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
- history of hypersensitivity to compounds of similar biological composition to IL-12,
aluminum hydroxide, or drugs formulated with polysorbate-20
- other systemic conditions or organ abnormalities that, in the opinion of the
Investigator, 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 events (imAEs)
following treatment with an agent that blocks the programmed cell death protein 1
(PD-1)/programmed cell death ligand 1 (PD-L1) pathway.
- Part 3 only: hypersensitivity to cemiplimab or any of its excipients or
contraindications to cemiplimab per approved local labeling