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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnkyra Therapeutics, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • tolododekin alfa
  • Cetrelimab

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators