Non Small Cell Lung CancerPhase 1NCT07027514
A Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer
A Phase 1 study testing tolododekin alfa and Cetrelimab in people with Non Small Cell Lung Cancer, run by Ankyra Therapeutics, Inc at 11 sites in United States.
Trial summary
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- tolododekin alfa and Cetrelimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Oct 2025to 31 Dec 2028
- 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
- Have confirmed locally advanced or metastatic NSCLC
- Thyroid-stimulating hormone (TSH) within normal limits
- Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
- Have a life expectancy > 12 weeks
- Have baseline electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT interval
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- Heterosexually active women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception
- Male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence
- Human immunodeficiency virus (HIV)-infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection/disease
- Resolution of all prior anticancer therapy toxicities prior to C1D1.
- Willingness to provide fresh tumor biopsy specimens
- Capable of understanding and complying with protocol requirements
- Provides written informed consent for the study
Who cannot join
- Cohort A only: Participants with toxic effects to manage adverse events from previous treatment with immunotherapy
- Cohort B only: Prior therapy with an immune checkpoint inhibitor.
- Have known EGFR or ALK mutations
- Have had prior treatment with recombinant interleukin-12 (IL-12)
- Have received short-term systemic therapy with immunosuppressive agents prior to C1D1
- Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior to C1D1
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- Have received live vaccines prior to C1D1
- Have primary or acquired immunodeficient states
- Female participant who is pregnant or breastfeeding
- Have a history of allogeneic tissue/solid organ transplant
- Has active hepatitis B virus (HBV) or hepatitis C virus (HCV).
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease
- Have known active central nervous system metastases
- Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias.
- Have uncontrolled bleeding disorders prior to C1D1
- Participants on coumadin (warfarin), due to potential for increased bleeding risk associated with surgery
- History of noninfectious pneumonitis
- Cohort A only: History of allergy to protein-based therapies, history of any significant drug allergy, or known allergies, hypersensitivity, or intolerance to cetrelimab excipients OR Cohort B only: Hypersensitivity to any component of the anti-PD-1/PD-L1 antibody selected as standard of care
- Have other systemic conditions or organ abnormalities that may interfere with the conduct of the study
- Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 10 recruiting
- Recruiting
Roswell Park Comprehensive Cancer Center
Buffalo, New York, 14263
Prantesh Jain, M.D., 7817185121, LANTERN@ankyratx.com
Prantesh Jain, M.D.
- Recruiting
University of Miami
Coral Gables, Florida, 33146
Estelamari Rodriguez, M.D., 7817185121, LANTERN@ankyratx.com
Estelamari Rodriguez, M.D.
- Withdrawn
Barbara Ann Karmanos Cancer Hospital
Detroit, Michigan, 48201
- Recruiting
Community Health Network
Indianapolis, Indiana, 46256
Neil Shukla, M.D., 7817185121, LANTERN@ankyratx.com
LANTERN@ankyratx.com
- Recruiting
Mayo Clinic
Jacksonville, Florida, 32224
Shenduo Li, M.D., 7817185121, LANTERN@ankyratx.com
Shenduo Li, M.D.
- Recruiting
Vanderbilt University
Nashville, Tennessee, 37232
Mohamed Shanshal, M.D., 7817185121, LANTERN@ankyratx.com
Mohamed Shanshal, D.O.
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Thomas Marron, M.D., 7817185121, LANTERN@ankyratx.com
Thomas Marron, M.D.
- Recruiting
OSF Healthcare System; Saint Francis Medical Center
Peoria, Illinois, 61637
Jun Zhang, M.D., 7817185121, LANTERN@ankyratx.com
Jun Zhang, M.D.
- Recruiting
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Sara Gordon, M.D., 7817185121, LANTERN@ankyratx.com
Sara Gordon, M.D.
- Recruiting
FirstHealth of the Carolinas
Pinehurst, North Carolina, 28374
Michael Pritchett, D.O., 7817185121, LANTERN@ankyratx.com
Michael Pritchett, D.O.
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Konstantin Levantakos, M.D., 781-718-5121, LANTERN@ankyratx.com
Konstantin Levantakos, M.D.
About this study
Official title: A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- tolododekin alfa, Cetrelimab
- Medical subject headings
- 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
Participants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W).
CetrelimabDrug
Participants will receive cetrelimab Q3W.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year Receives: Drug: tolododekin alfa; Drug: Cetrelimab |
| Cohort B | Experimental | Participants will receive up to 8 cycles of tolododekin alfa in combination with the Investigator's choice of a Food and Drug Administration (FDA)-approved anti-PD-1/PD-L1 antibody given according to the FDA-approved label Receives: Drug: tolododekin alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Percentage of participants with complete response (CR) or partial response (PR) among all response evaluable participants
Measured: 6 months
Secondary outcomes (12)
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Number of participants with adverse events (TEAEs, SAEs)
Measured: 6 months
Duration of Response (DoR)
Time from first CR/PR to the date of progressive disease (PD) or death.
Measured: 6 months
Disease Control Rate (DCR)
The percentage of participants with stable disease, complete response or partial response among all response evaluable participants
Measured: 6 months
Progression Free Survival (PFS)
The duration from the first dose of tolododekin alfa until PD/death
Measured: 6 months
Overall Survival (OS)
The length of time participants remain alive starting from the first dose of tolododekin alfa
Measured: 6 months
Lesion-level response in injected and noninjected lesions
Measure response in injected and noninjected lesions
Measured: 6 months
Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter AUC after IT injection of tolododekin alfa
Measured: 6 months
Measure of maximum plasma concentration (Cmax) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter Cmax after IT injection of tolododekin alfa
Measured: 6 months
Measure of time to maximum concentration (Tmax) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter Tmax after IT injection of tolododekin alfa
Measured: 6 months
Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter Vd/F after IT administration of tolododekin alfa
Measured: 6 months
Measure of terminal half-life (t1/2) of tolododekin alfa
Characterize pharmacokinetic (PK) parameter t1/2 after IT administration of tolododekin alfa
Measured: 6 months
Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa
Quantification of ADAs after IT administration of tolododekin alfa
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start22 Oct 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankyra Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027514
- Sponsor's protocol ID
- ANK-101-004
- Status last verified
- Sep 2026
- First submitted
- 11 Jun 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Two-Part Study of Tolododekin Alfa (ANK-101) in Combination With an Anti-PD-1/PD-L1 Antibody in Participants With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT07027514
- Acronym / sponsor ID
- ANK-101-004
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankyra Therapeutics, IncIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 18 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study of tolododekin alfa (also known as ANK-101) administered in combination with an anti-programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) antibody in participants with advanced or metastatic non-small cell lung cancer (NSCLC). Cohort A will enroll participants who have progressed on prior standard of care treatment with an anti-PD-1/PD-L1 antibody and a platinum-based chemotherapy regimen. Cohort B will enroll participants who are treatment-naïve for locally advanced or metastatic NSCLC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: tolododekin alfa, Drug: CetrelimabParticipants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year |
| Cohort B | Experimental | Drug: tolododekin alfaParticipants will receive up to 8 cycles of tolododekin alfa in combination with the Investigator's choice of a Food and Drug Administration (FDA)-approved anti-PD-1/PD-L1 antibody given according to the FDA-approved label |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Have confirmed locally advanced or metastatic NSCLC
- Thyroid-stimulating hormone (TSH) within normal limits
- Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1
- Have a life expectancy > 12 weeks
Key exclusion criteria (20 listed)
- Cohort A only: Participants with toxic effects to manage adverse events from previous treatment with immunotherapy
- Cohort B only: Prior therapy with an immune checkpoint inhibitor.
- Have known EGFR or ALK mutations
- Have had prior treatment with recombinant interleukin-12 (IL-12)
- Have received short-term systemic therapy with immunosuppressive agents prior to C1D1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tolododekin alfaParticipants will receive tolododekin alfa as an intratumoral injection every 3 weeks (Q3W). | Drug | Cohort A, Cohort B |
| CetrelimabParticipants will receive cetrelimab Q3W. | Drug | Cohort A |
Primary outcome
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
Time frame: 6 months
Percentage of participants with complete response (CR) or partial response (PR) among all response evaluable participants
12 secondary outcomes
Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: 6 months
Duration of Response (DoR)
Time frame: 6 months
Disease Control Rate (DCR)
Time frame: 6 months
Progression Free Survival (PFS)
Time frame: 6 months
Overall Survival (OS)
Time frame: 6 months
Lesion-level response in injected and noninjected lesions
Time frame: 6 months
Measure of area under the plasma concentration-time curve (AUC) of tolododekin alfa
Time frame: 6 months
Measure of maximum plasma concentration (Cmax) of tolododekin alfa
Time frame: 6 months
Measure of time to maximum concentration (Tmax) of tolododekin alfa
Time frame: 6 months
Measure of volume of distribution adjusted for bioavailability (Vd/F) of tolododekin alfa
Time frame: 6 months
Measure of terminal half-life (t1/2) of tolododekin alfa
Time frame: 6 months
Incidence of treatment-emergent anti-drug antibodies (ADA) of tolododekin alfa
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tolododekin alfa and Cetrelimab in people with Non Small Cell Lung Cancer, run by Ankyra Therapeutics, Inc at 11 sites in United States.
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 13 inclusion and 20 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 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 Ankyra Therapeutics (7817185121, LANTERN@ankyratx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2026.