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New treatment option for Non Small Cell Lung Cancer
Official title 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
ClinicalTrials.gov ID: NCT07027514
What this study is testing
What is tolododekin alfa?
tolododekin alfa is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for non small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- Cohort A only: Participants with Grade 3 or higher 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 toC1D1
See the full eligibility criteria
- 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
- Heterosexually active women of childbearing potential (WOCBP) must agree to use at least 2 forms of highly effective methods of contraception
- All 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 to ≤ Grade 1 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
- Cohort A only: Participants with Grade 3 or higher 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 toC1D1
- Have received live vaccines within 28 days prior to C1D1
- Have primary or acquired immunodeficient states
- Women of childbearing potential who has a positive serum pregnancy test prior to C1D1 or female participant who is breastfeeding
- Have a history of allogeneic tissue/solid organ transplant
- Has known active uncontrolled 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 within the previous 5 years
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Indianapolis, Indiana, United States
- Detroit, Michigan, United States
- Buffalo, New York, United States
- New York, New York, United States
- Pinehurst, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Indianapolis, Indiana, United States; Detroit, Michigan, United States; Buffalo, New York, United States; New York, New York, United States; Pinehurst, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.