Beigene, Ltd. ((ONC)) announced an update on their ongoing clinical study.
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Beigene, Ltd. is currently conducting a Phase 1a/1b clinical study titled A Phase 1a/1b Study of BG-68501, a Selective CDK2 Inhibitor, in Participants With Advanced Solid Tumors. The study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of BG-68501 in patients with advanced, nonresectable, or metastatic solid tumors. This study is significant as it seeks to identify a recommended dose for future studies.
The study involves testing BG-68501, a cyclin-dependent kinase-2 inhibitor, both as a monotherapy and in combination with fulvestrant and BGB-43395, targeting hormone receptor-positive, HER2-negative breast cancer. These interventions aim to assess their effectiveness in treating advanced-stage tumors.
The study design is interventional, non-randomized, and sequential, with no masking. Its primary purpose is treatment-focused, aiming to determine the optimal dosing strategy for BG-68501.
The study began on March 11, 2024, with its primary completion and estimated overall completion dates yet to be announced. The last update was submitted on June 27, 2025, indicating ongoing progress in the study.
This clinical update could influence Beigene’s stock performance positively, as successful results may enhance investor confidence and position the company favorably against competitors in the oncology sector. The study’s progress is crucial for Beigene’s strategic positioning in the market.
The study is ongoing, with further details available on the ClinicalTrials portal.