Recruiting
Phase 1

ANK-101

Sponsor:

Ankyra Therapeutics, Inc

Code:

NCT06171750

Conditions

Advanced Solid Tumor

Cutaneous Tumor

Subcutaneous Tumor

Malignant Solid Tumor

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

tolododekin alfa

Cemiplimab

Study Details

Brief summary:

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.

Conditions

Advanced Solid Tumor

Cutaneous Tumor

Subcutaneous Tumor

Malignant Solid Tumor

Solid Tumor

Study ID

NCT06171750

Start date

Jan 19, 2024

Status verified date

Mar, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

97 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tolododekin alfa (ANK-101) IT Injection in Superficial Lesions

IT injections of ANK-101 once every 3 weeks into superficial lesions

experimental: tolododekin alfa (ANK-101) IT Injection in Visceral Lesions

IT injections of ANK-101 once every 3 weeks into visceral lesions and every 6 weeks in the expansion

experimental: tolododekin alfa (ANK-101) IT Injection in Combination with Cemiplimab

IT injections of ANK-101 once every 3 weeks in combination with Cemiplimab into patients with high-risk locally advanced or metastatic CSCC that have superficial lesions

Interventions

tolododekin alfa

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.

Cemiplimab

Participants 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.

Primary outcome measure

  • Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEs [ Time Frame: From Day 1 to 90 days after last injection of ANK-101 ]
  • RDE of ANK-101 [ Time Frame: Approximately 12 months ]
  • Incidence and characteristics of TEAEs of ANK-101 in combination with Cemiplimab according to NCI CTCAE v5.0 (Part 3 only) [ Time Frame: From Day 1 to 90 days after last injection of ANK-101 in combination with Cemiplimab. ]

Central Contacts and Locations

Central contacts

Gail Iodice, BSN, RN

347-882-1147giodice@ankyratx.com

Locations

National Cancer Institute

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Hoyoung Maeng, MD

240-781-3253hoyoung.maeng@nih.gov

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jong Park, MD

617-724-4000JPARK73@MGH.HARVARD.EDU

Providence Cancer Institute

Recruiting

Portland, Oregon, United States, 97213

Contacts

Brendan Curti, MD

CanRsrchStudies@providence.org

Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Danielle Bednarz, BS, RN

412-623-1191bednarzdl@upmc.edu

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Marcus Butler, MD

(416) 946-4575Marcus.Butler@uhn.ca

More Information

Sponsor

Ankyra Therapeutics, Inc

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • intratumoral
  • intratumoral injection
  • solid tumors
  • superficial tumors
  • nodal tumors
  • subcutaneous tumors
  • visceral tumors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ankyra Therapeutics, Inc on 2026-03-06.