RecruitingPhase 1

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 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests tolododekin alfa (ANK-101) with an anti-PD-1/PD-L1 antibody, a type of immune treatment. It is for people with non-small cell lung cancer that has grown into nearby areas or spread to other parts of the body. One group has cancer that worsened after standard immune treatment and platinum-based chemotherapy; the other has not been treated for advanced 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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have confirmed advanced non-small cell lung cancer with tumors that can be measured.
  • Be fully active or able to do light work, and be expected to live more than 12 weeks.
  • Have a normal thyroid hormone test and a heart tracing without signs of a new blood-flow problem or a certain abnormal heart rhythm.
  • Side effects from past cancer treatment must have cleared before the first study dose.
  • Agree to give fresh tumor samples and be able to understand and follow study rules.
  • Give written consent to join the study.
  • Women who can become pregnant and have sex with men must use highly effective birth control. Men who can father a child must use reliable birth control or avoid sex.
  • People with HIV must take HIV medicine and have well-controlled HIV.

Who can't join

  • Group A: certain toxic effects from past immune treatment, significant drug allergies, allergies to protein-based treatments, or reactions to cetrelimab ingredients. Group B: past immune checkpoint treatment or allergy to the chosen immune treatment.
  • Known EGFR or ALK gene changes, or past treatment with lab-made interleukin-12 (IL-12).
  • An active disease where the immune system attacks the body, a weakened immune system, recent immune-suppressing treatment or live vaccines, or a need for long-term steroids or other immune-suppressing drugs.
  • Pregnancy, breastfeeding, or a past tissue or organ transplant from another person.
  • Active hepatitis B or C; or HIV with a history of Kaposi sarcoma or multicentric Castleman disease.
  • Known active cancer spread to the brain or spinal cord, or past lung swelling not caused by infection.
  • Certain serious heart problems, uncontrolled bleeding problems, or use of warfarin (Coumadin), a blood thinner.
  • Other illnesses, organ problems, mental health problems, or substance use disorders that could make study participation unsuitable.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Have confirmed locally advanced or metastatic NSCLC 2. Thyroid-stimulating hormone (TSH) within normal limits 3. Have measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) 4. Eastern Cooperative Oncology Group performance status (ECOG PS) 0 to 1 5. Have a life expectancy \> 12 weeks 6. Have baseline electrocardiogram (ECG) without evidence of acute ischemia or prolonged QT interval 7. Heterosexually active women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception 8. Male participants who are not sterile must commit to the use of a reliable method of birth control or abstinence 9. Human immunodeficiency virus (HIV)-infected participants must be on anti-retroviral therapy (ART) and have well-controlled HIV infection/disease 10. Resolution of all prior anticancer therapy toxicities prior to C1D1. 11. Willingness to provide fresh tumor biopsy specimens 12. Capable of understanding and complying with protocol requirements 13. Provides written informed consent for the study Exclusion Criteria: 1. Cohort A only: Participants with toxic effects to manage adverse events from previous treatment with immunotherapy 2. Cohort B only: Prior therapy with an immune checkpoint inhibitor. 3. Have known EGFR or ALK mutations 4. Have had prior treatment with recombinant interleukin-12 (IL-12) 5. Have received short-term systemic therapy with immunosuppressive agents prior to C1D1 6. Have active autoimmune disease or medical conditions requiring chronic steroid or other immunosuppressive therapy prior to C1D1 7. Have received live vaccines prior to C1D1 8. Have primary or acquired immunodeficient states 9. Female participant who is pregnant or breastfeeding 10. Have a history of allogeneic tissue/solid organ transplant 11. Has active hepatitis B virus (HBV) or hepatitis C virus (HCV). 12. HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease 13. Have known active central nervous system metastases 14. Have congestive heart failure, active coronary artery disease, unevaluated new onset angina, unstable angina, or clinically significant cardiac arrhythmias. 15. Have uncontrolled bleeding disorders prior to C1D1 16. Participants on coumadin (warfarin), due to potential for increased bleeding risk associated with surgery 17. History of noninfectious pneumonitis 18. 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 19. Have other systemic conditions or organ abnormalities that may interfere with the conduct of the study 20. Have any acute or chronic psychiatric problems or substance abuse disorder that make the participant unsuitable for participation

Study sites (11)

FL

IL

IN

MI

MN

NC

NY

PA

TN