This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of tolododekin alfa (ANK-101) in participants with advanced solid tumors who have progressed during or after receiving standard of care (SOC) therapy or who will not benefit from such therapy. The study will be conducted in three parts; in Part 1, participants with superficial lesions will receive ANK-101 as a single agent; in Part 2, participants with visceral lesions will receive ANK-101 as a single agent; and in Part 3, participants with cutaneous squamous cell carcinoma (CSCC) will receive ANK-101 in combination with cemiplimab.
≥ 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.
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
Parallel
tolododekin alfa
DrugIT administration of ANK-101 once every 3 weeks for up to 12 weeks (4 doses); if there is no disease progression, decrease in clinical performance status or unacceptable toxicity, participants may receive 4 additional doses of ANK-101.
Cemiplimab
DrugParticipants will receive four cycles of ANK-101 in combination with Cemiplimab. If there is no significant clinical deterioration as determined by the Investigator or unacceptable toxicity at Week 12, participants may receive an additional four cycles of the combination treatment. After stopping ANK-101 treatment, participants may stay on Cemiplimab monotherapy for an additional 24 weeks.
Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEs
Number and percentage of participants reporting each DLT or TEAE.
RDE of ANK-101
Defined based on the rate of DLTs and TEAEs
Incidence and characteristics of TEAEs of ANK-101 in combination with Cemiplimab according to NCI CTCAE v5.0 (Part 3 only)
Number and percentage of participants reporting each TEAE.
PK: Cmax of IL-12-ABP
PK of IL-12-ABP as assessed by maximum plasma concentration (Cmax)
PK: AUC of IL-12-ABP
PK of IL-12-ABP as assessed by area under the time-concentration curve (AUC)
PK: t ½ of IL-12-ABP
PK of IL-12-ABP as assessed by terminal half-life (t ½)
PK: CL/F of IL-12-ABP
PK of IL-12-ABP as assessed by apparent clearance (CL/F)
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