Purpose

This is a Phase 1, multicenter, open-label dose escalation study to determine the safety and tolerability of intratumoral (IT) injection of ANK-101 in participants with advanced solid tumors.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 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). - documented disease progression, be refractory to, or intolerant of existing SOC therapy(ies) known to provide clinical benefit 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 > 440 msec in men and > 460 msec in women - 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 - 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

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ANK-101 IT Injection
IT injections of ANK-101 once every 3 weeks
  • Drug: ANK-101
    IT 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.

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Jong Park, MD
617-724-4000
JPARK73@MGH.HARVARD.EDU

More Details

Status
Recruiting
Sponsor
Ankyra Therapeutics, Inc

Study Contact

Gail Iodice, BSN, RN
347-882-1147
giodice@ankyratx.com

Detailed Description

This Phase 1 first-in-human (FIH) study will: 1) evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects and preliminary clinical activity of ANK-101 administered as an intratumoral (IT) injection; and 2) determine the recommended dose for expansion (RDE) of ANK-101. The study design consists of six sequential dose-escalation cohorts and an expansion cohort at the RDE. Eligible participants with accessible cutaneous, subcutaneous, soft tissue or nodal malignancies who have progressed during or after receiving standard of care (SOC) therapy or who would not benefit from such therapy will be enrolled.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.