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.
• 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