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

Ankyra Therapeutics

Status and phase

Enrolling

Phase 1

Conditions

Non Small Cell Lung Cancer

Treatments

Drug: tolododekin alfa

Drug: Cetrelimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT07027514

ANK-101-004

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion 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

Exclusion criteria

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 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 design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

Cohort A

Experimental group

Description:

Participants will receive up to 8 cycles of tolododekin alfa in combination with cetrelimab given for up to 1 year

Treatment:

Drug: Cetrelimab

Drug: tolododekin alfa

Cohort B

Experimental group

Description:

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

Treatment:

Drug: tolododekin alfa

Trial contacts and locations

Central trial contact

Ankyra Therapeutics

Data sourced from clinicaltrials.gov

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