NCI-2025-07002

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

This Phase 1b, two-part research study is studying a new investigational therapy called Tolododekin Alfa (ANK-101) in combination with an anti–PD-1 or PD-L1 antibody for people with advanced non-small cell lung cancer (NSCLC). Tolododekin Alfa (ANK-101) is an experimental immune-modulating drug designed to boost the body’s immune response against cancer. The anti–PD-1/PD-L1 antibodies—such as pembrolizumab or nivolumab—are already approved immune checkpoint inhibitors that help the immune system recognize and attack cancer cells. The combination aims to see whether adding ANK-101 can enhance the effectiveness of existing immunotherapy and help more patients respond to treatment. The goal is to determine if this combination can provide a stronger and more durable immune response in patients with advanced NSCLC whose cancer has become resistant or progressed despite prior therapies.

PD-L1: is a protein that regulates the immune system's response to cancer cells, and helps cancer cells hide from the body's immune system.

Advanced: Advanced cancer means that the cancer cells from the original tumor (primary tumor) get loose, spread by traveling through the body, and start a new tumor (metastatic tumor) somewhere else in the body.

Non-small cell lung cancer: A type of lung cancer with non small cells that grow too much and can spread to other parts of the body

For more information about the trial, click the link below:

https://clinicaltrials.gov/ct2/show/NCT07027514

Clinical Trial Site: Sinai

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