RECRUITING

Phase I Study of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

Conditions

Advanced Solid Tumor Cutaneous Tumor Subcutaneous Tumor Malignant Solid Tumor Solid Tumor Metastatic Solid Tumor Metastasis to Soft Tissue Non Small Cell Lung Cancer Cutaneous Squamous Cell Carcinoma intratumoral intratumoral injection solid tumors superficial tumors nodal tumors subcutaneous tumors visceral tumors

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I Open-Label, Dose Escalation Study of the Safety and Tolerability of Tolododekin Alfa (ANK-101) in Advanced Solid Tumors

Quick Facts

Study Start:2024-01-19

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06171750

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Gail Iodice, BSN, RN

CONTACT

347-882-1147

giodice@ankyratx.com

Principal Investigator

Joseph Elassal, MD, MBA

STUDY_DIRECTOR

Ankyra Therapeutics, Inc

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Providence Cancer Institute

Portland, Oregon, 97213

United States

Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: Ankyra Therapeutics, Inc

Joseph Elassal, MD, MBA, STUDY_DIRECTOR, Ankyra Therapeutics, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-19

Study Completion Date2026-01

Study Record Updates

Study Start Date2024-01-19

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Advanced Solid Tumor
Cutaneous Tumor
Subcutaneous Tumor
Malignant Solid Tumor
Solid Tumor
Metastatic Solid Tumor
Metastasis to Soft Tissue
Non Small Cell Lung Cancer
Cutaneous Squamous Cell Carcinoma