drugset / Trial / NCT05208944

THIO Sequenced With Cemiplimab in Advanced NSCLC

NCT05208944

Phase 2 Active not recruiting 227 enrolled Maia Biotechnology
RandomizedSequentialOpen-labelTreatment

Summary

THIO is a first-in-class small molecule telomere targeting agent, in development for the treatment of non-small cell lung cancer (NSCLC) in combination with cemiplimab (LIBTAYO®). THIO is preferentially incorporated into telomeres sequence in telomerase-positive cells leading to rapid telomere uncapping, genomic instability, and cell death. Cemiplimab is a programmed cell death protein 1 (PD-1) inhibitor recently approved as a first-line treatment for patients with locally advanced or metastatic NSCLC with 50% or more PD-L1 expression. It is hypothesized that THIO administration prior to cemiplimab would restore tumor responses to immunotherapy in subjects who either developed resistance or relapsed after receiving first line treatment with an immune check point inhibitor.

Timeline

Start
2022-06-08
Primary completion
2027-09-30
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cemiplimab Monoclonal antibody 350 mg Intravenous
Subject ateganosine Small molecule 20 mg Intravenous
Subject ateganosine Small molecule 60 mg Intravenous
Subject ateganosine Small molecule 120 mg Intravenous