GlaxoSmithKline ((GSK)), GlaxoSmithKline plc (UK) ((GB:GSK)), Ideaya Biosciences ((IDYA)) announced an update on their ongoing clinical study.
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GlaxoSmithKline (GSK) and Ideaya Biosciences are conducting a study titled ‘A Phase 1/2 First-Time-in-Human, Open-label, Multicenter, Dose Escalation and Expansion Study of the Oral DNA Helicase Werner Inhibitor (WRNi) GSK4418959 Alone or in Combination With Other Anti-cancer Agents in Adult Participants With Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors (SYLVER)’. The study aims to evaluate the safety, pharmacokinetics, and preliminary effectiveness of GSK4418959, alone or combined with a PD-1 inhibitor, in reducing tumor size in participants with specific genetic tumor characteristics.
The intervention being tested is GSK4418959, an experimental drug administered alone or with a PD-1 inhibitor, intended to target and reduce solid tumors with aggressive genetic traits.
This interventional study follows a non-randomized, sequential model with no masking, focusing primarily on treatment. It is structured in phases 1 and 2, including dose escalation and expansion parts for GSK4418959, both as monotherapy and in combination with a PD-1 inhibitor.
The study began on December 13, 2024, with its primary completion and estimated completion dates yet to be announced. The latest update was submitted on August 5, 2025, indicating ongoing recruitment.
This study update could influence GSK and Ideaya Biosciences’ stock performance by boosting investor confidence due to the potential success of GSK4418959 in treating challenging tumors. As the study progresses, it may also impact the competitive landscape in the oncology sector.
The study is ongoing, with further details available on the ClinicalTrials portal.