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Advanced Solid TumorPhase 1ANCHORNCT06171750

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

A Phase 1 study testing tolododekin alfa and Cemiplimab in people with Advanced Solid Tumor and Cutaneous Tumor, run by Ankyra Therapeutics, Inc at 5 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
tolododekin alfa and Cemiplimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
5 sitesin 2 countries
Study dates
19 Jan 2024to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Gail Iodice, BSN, RN contact

347-882-1147

giodice@ankyratx.com

5 sites in 2 countries

United States4 sites, 4 recruiting

  • National Cancer Institute

    Bethesda, Maryland, 20892

    Hoyoung Maeng, MD, 240-781-3253, hoyoung.maeng@nih.gov

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Jong Park, MD, 617-724-4000, JPARK73@MGH.HARVARD.EDU

    Recruiting

  • Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Danielle Bednarz, BS, RN, 412-623-1191, bednarzdl@upmc.edu

    Recruiting

  • Providence Cancer Institute

    Portland, Oregon, 97213

    Brendan Curti, MD, CanRsrchStudies@providence.org

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

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

    Recruiting

Other trials in Canada

About this study

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

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.

Read the 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 tolododekin alfa (ANK-101) administered as an intratumoral (IT) injection in participants with superficial or visceral lesions; 2) determine the recommended dose for expansion (RDE) of ANK-101; and 3) to determine the safety and tolerability of ANK-101 in combination with cemiplimab.

For parts 1 and 2, the study design consists of six sequential dose-escalation cohorts. Part 1 will enroll participants with advanced solid tumors, with cutaneous, subcutaneous or nodal disease (accessible by clinical palpation or ultrasound guidance). Part 2 will start once the DLT period of dose level 1 in Part 1 is completed and dose level 2 is opened. Part 2 will enroll participants with visceral disease (accessible by interventional radiology or endoscopic techniques). Participants in Part 2 may also have superficial lesions that can be injected if in the Investigator's opinion this is clinically indicated.

Ten participants with non-small cell lung cancer (NSCLC) will be dosed in a Part 2 dose expansion cohort at the RDE.

Part 3 will start once dose escalation for Part 1 is complete and the RDE is identified. Part 3 will consist of ANK-101 in combination with cemiplimab in 15 participants with high-risk locally advanced or metastatic CSCC that have superficial lesions for injection. Participants will be treated with ANK-101 given as IT injections once every three weeks at the RDE in combination with cemiplimab.

Enrollment in Part 3 will include a safety run-in of 5 participants. Following the first dose of the 5th participant, enrollment will pause for 21 days before opening enrollment to the remaining 10 participants or stopping further enrollment.

Being tested
tolododekin alfa, Cemiplimab
Keywords
intratumoral, intratumoral injection, solid tumors, superficial tumors, nodal tumors, subcutaneous tumors, visceral tumors
Medical subject headings
Skin Neoplasms, Neoplasm Metastasis, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tolododekin alfaDrug

    Also called 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.

  • CemiplimabDrug

    Also called Libtayo

    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.

Study groups in NCT06171750
Study groupRoleWhat they receive
tolododekin alfa (ANK-101) IT Injection in Superficial LesionsExperimentalIT injections of ANK-101 once every 3 weeks into superficial lesions
Receives: Drug: tolododekin alfa
tolododekin alfa (ANK-101) IT Injection in Visceral LesionsExperimentalIT injections of ANK-101 once every 3 weeks into visceral lesions and every 6 weeks in the expansion
Receives: Drug: tolododekin alfa
tolododekin alfa (ANK-101) IT Injection in Combination with CemiplimabExperimentalIT 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
Receives: Drug: tolododekin alfa; Drug: Cemiplimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and characteristics of DLTs (Parts 1 and 2 only) and TEAEs

    Number and percentage of participants reporting each DLT or TEAE.

    Measured: From Day 1 to 90 days after last injection of ANK-101

  2. RDE of ANK-101

    Defined based on the rate of DLTs and TEAEs

    Measured: Approximately 12 months

  3. 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.

    Measured: From Day 1 to 90 days after last injection of ANK-101 in combination with Cemiplimab.

Secondary outcomes (10)

  1. PK: Cmax of IL-12-ABP

    PK of IL-12-ABP as assessed by maximum plasma concentration (Cmax)

    Measured: Up to 2 years

  2. PK: AUC of IL-12-ABP

    PK of IL-12-ABP as assessed by area under the time-concentration curve (AUC)

    Measured: Up to 2 years

  3. PK: t ½ of IL-12-ABP

    PK of IL-12-ABP as assessed by terminal half-life (t ½)

    Measured: Up to 2 years

  4. PK: CL/F of IL-12-ABP

    PK of IL-12-ABP as assessed by apparent clearance (CL/F)

    Measured: Up to 2 years

  5. PK: Vss/F of IL-12-ABP

    PK of IL-12-ABP as assessed by apparent volume of distribution at steady state (Vss/F)

    Measured: Up to 2 years

  6. Levels of ADA in serum

    Number and percentage of participants with serum levels of anti drug antibodies (ADA) after treatment

    Measured: Up to 2 years

  7. ORR by RECIST v1.1

    Number of participants with a best overall RECIST response (BOR) of CR or PR based on RECIST v1.1

    Measured: Up to 2 years

  8. DCR by RECIST v1.1

    Number of participants with SD, CR and PR.

    Measured: Up to 2 years

  9. DOR by RECIST v1.1

    Time from when the criteria for RECIST v1.1 CR or PR (whichever is recorded first) was first met until the date when PD is documented

    Measured: Up to 2 years

  10. PFS by RECIST v1.1

    Time from C1D1 to PD or death from any cause

    Measured: UP to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2023
  2. Study start19 Jan 2024
  3. Primary completionApr 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06171750
Sponsor's protocol ID
ANK-101-001
Acronym
ANCHOR
Status last verified
Mar 2026
First submitted
29 Nov 2023
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Park JC, Curti B, Butler M, Wehrenberg-Klee E, Elassal J, Tighe R, Battula S, Iodice G, Kaufman HL, Kirkwood JM. Interleukin-12 anchored drug conjugate (tolododekin alfa) in patients with advanced solid tumors: first-in-human Phase 1 trial. Nat Commun. 2025 Sep 29;16(1):8567. doi: 10.1038/s41467-025-63579-9.

    PubMed 41022754

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tolododekin alfa and Cemiplimab in people with Advanced Solid Tumor and Cutaneous Tumor, run by Ankyra Therapeutics, Inc at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gail Iodice, BSN, RN (347-882-1147, giodice@ankyratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06171750, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.

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