Trial results for the Phase 1 study NCT02783300, which included pembrolizumab as an intervention, were posted on ClinicalTrials.gov on 2025-03-10. This open-label, dose escalation study investigated GSK3326595 in participants with solid tumors and non-Hodgkin's lymphoma, with safety data for GSK3326595 now available. The study reported adverse events and serious adverse events across various doses of GSK3326595, with up to 19 participants experiencing any AE/SAE in one dose group.
Background
The study's brief summary describes it as a first-time-in-human (FTIH) open-label, dose escalation study. It aimed to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-Hodgkin's lymphoma (NHL). Pembrolizumab was listed as an intervention in this study.
Trial design
The study, identified as NCT02783300, was a Phase 1, open-label, dose escalation trial. It enrolled 297 participants with Neoplasms, specifically advanced or recurrent solid tumors and non-Hodgkin's lymphoma. The interventions included GSK3326595 and pembrolizumab. The study's primary objective involved assessing safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity.
Key results
The trial results posted focused on the safety profile of GSK3326595, specifically the "Number of Participants With Any Adverse Events (AEs) and Serious Adverse Events (SAEs)" in Part 1 of the study. The data is presented for various daily and twice-daily doses of GSK3326595:
- For GSK3326595 12.5 mg Once a Day (QD), 1 participant experienced any AE/SAE.
- For GSK3326595 25 mg QD, 1 participant experienced any AE/SAE.
- For GSK3326595 50 mg QD), 1 participant experienced any AE/SAE.
- For GSK3326595 100 mg QD, 1 participant experienced any AE/SAE.
- For GSK3326595 200 mg QD, 7 participants experienced any AE/SAE.
- For GSK3326595 300 mg QD, 3 participants experienced any AE/SAE.
- For GSK3326595 400 mg QD, 19 participants experienced any AE/SAE.
- For GSK3326595 600 mg QD, 3 participants experienced any AE/SAE.
- For GSK3326595 50 mg Twice Daily (BID), 1 participant experienced any AE/SAE.
- For GSK3326595 100 mg BID, 7 participants experienced any AE/SAE.
- For GSK3326595 150 mg BID, 6 participants experienced any AE/SAE.
- For GSK3326595 200 mg BID, 3 participants experienced any AE/SAE.
These measurements reflect the safety observations during the dose escalation phase for GSK3326595.
What this means
The posted results provide initial safety data for GSK3326595 as part of a Phase 1 dose escalation study involving participants with solid tumors and non-Hodgkin's lymphoma, where pembrolizumab was also an intervention. The varying counts of participants experiencing adverse events and serious adverse events across different dose levels of GSK3326595 offer preliminary insights into its safety profile in this patient population. These findings are crucial for understanding the tolerability of GSK3326595 and guiding further clinical development, potentially in combination with agents like pembrolizumab.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT02783300, titled "An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma," were posted on 2025-03-10 on clinicaltrials.gov.