Trial results for the Phase 2 study (NCT05141357) investigating HBI-8000 (Tucidinostat) in combination with pembrolizumab for non-small cell lung cancer were posted on ClinicalTrials.gov on 2025-12-24. The study, which aimed to assess safety and efficacy, was terminated after enrolling only 5 participants.
Background
The study, titled "A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer," was a Phase 2 trial designed to assess the safety and efficacy of HBI-8000 in combination with pembrolizumab for advanced or metastatic non-small cell lung cancer (NSCLC).
Trial design
The study (NCT05141357) was a Phase 2 trial with an overall status of TERMINATED. It enrolled 5 participants diagnosed with advanced or metastatic non-small cell lung cancer (NSCLC). The intervention involved administering HBI-8000 in combination with pembrolizumab.
What this means
The early termination of this Phase 2 study with only 5 participants indicates that the trial did not progress to a stage where comprehensive efficacy or safety data could be collected. While the specific reasons for termination are not detailed in the posted results, the limited enrollment suggests that further investigation into the combination of HBI-8000 and pembrolizumab for non-small cell lung cancer in this particular trial was halted prematurely.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05141357, titled "A Study of HBI-8000 (Tucidinostat) With Pembrolizumab in Non-Small Cell Lung Cancer," were posted on 2025-12-24 on clinicaltrials.gov.