Trial results for the Phase 1/2 study investigating atezolizumab in combination with alomfilimab for advanced malignancies were posted on ClinicalTrials.gov on 2025-04-02. The study, which was terminated, detailed the number of participants experiencing treatment-emergent adverse events (TEAEs) across various dose groups of alomfilimab alone and in combination with atezolizumab.
Background
Atezolizumab is an anti-PD-L1 therapy. This study investigated alomfilimab as a single agent and in combination with atezolizumab in adult patients with selected advanced malignancies, including squamous cell carcinoma of the head and neck, non-small cell lung cancer, hepatocellular carcinoma, esophageal cancer, and gastric cancer.
Trial design
The study (NCT03829501) was a Phase 1/2, open-label, multi-center trial that enrolled 222 participants. It investigated alomfilimab as a single agent and in combination with atezolizumab in adult patients with selected advanced malignancies, specifically squamous cell carcinoma of the head and neck, non-small cell lung cancer, hepatocellular carcinoma, esophageal cancer, and gastric cancer. The trial's overall status is terminated.
Key results
The trial results focused on the number of participants experiencing treatment-emergent adverse events (TEAEs) during Phase 1 of the study. The counts of participants experiencing TEAEs across different treatment groups were:
- For alomfilimab 0.8 mg alone, 4 Participants experienced TEAEs.
- For alomfilimab 2.4 mg alone, 4 Participants experienced TEAEs.
- For alomfilimab 8 mg alone, 8 Participants experienced TEAEs.
- For alomfilimab 24 mg alone, 7 Participants experienced TEAEs.
- For alomfilimab 80 mg alone, 7 Participants experienced TEAEs.
- For alomfilimab 240 mg alone, 5 Participants experienced TEAEs.
- For alomfilimab 0.8 mg + atezolizumab, 4 Participants experienced TEAEs.
- For alomfilimab 2.4 mg + atezolizumab, 43 Participants experienced TEAEs.
- For alomfilimab 8 mg + atezolizumab, 34 Participants experienced TEAEs.
- For alomfilimab 24 mg + atezolizumab, 9 Participants experienced TEAEs.
- For alomfilimab 80 mg + atezolizumab, 9 Participants experienced TEAEs.
- For alomfilimab 0.8 mg alone, 1 Participant experienced TEAEs.
What this means
The posted results provide safety data from the Phase 1 portion of the terminated study, detailing the incidence of treatment-emergent adverse events across various dose levels of alomfilimab as a monotherapy and in combination with atezolizumab. These findings contribute to the understanding of the safety profile of alomfilimab and its combination with atezolizumab in patients with advanced malignancies during early-phase investigation.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03829501, titled "A Phase 1/2, Open-label, Multi-center Study of the Safety and Efficacy of Alomfilimab (KY1044) as Single Agent and in Combination With Anti-PD-L1 (Atezolizumab) in Adult Patients With Selected Advanced Malignancies," were posted on 2025-04-02 on clinicaltrials.gov.