BeOne Medicines Advances Early Cancer Trial for BG-75098, Signaling Steady Pipeline Progress

BeOne Medicines (ONC) announced an update on their ongoing clinical study.

BeOne Medicines is running an early-stage trial to test a new cancer drug, BG-75098, in adults with advanced solid tumors. The official title shows a Phase 1a/1b open-label study that aims to assess safety, side effects, how the drug moves and acts in the body, and any early signs that it can shrink or control tumors. For investors, this is a classic “first-in-human” style program where the main question is whether the drug looks safe enough, and active enough, to justify larger, value-creating trials.

The study tests BG-75098 both as a stand-alone pill and in combination with two other drugs: BGB-43395, another oral agent, and fulvestrant, an injected hormone therapy widely used in breast cancer. BG-75098 and BGB-43395 are experimental, while fulvestrant is an established drug, so the combinations are meant to see if BG-75098 can boost the effect of standard care and other pipeline assets.

The trial is interventional and non-randomized, meaning there is no placebo or direct comparison arm at this stage. Patients are enrolled into groups in sequence, starting at low doses and moving higher as safety allows, with no blinding for patients or doctors. The primary goal is treatment-focused: to find safe dose levels and get an early read on whether the drug shows enough benefit to move into later, more definitive studies.

The study recently updated its status to “recruiting,” meaning sites are open and enrolling patients. The initial submission came on November 6, 2025, and the most recent update was filed on December 22, 2025, signaling that the protocol is active and being maintained. Key future milestones will be the primary completion date, when main safety and early activity data are locked, and the final completion date, when longer-term follow-up is finished and a full data set is ready for strategic decisions.

From a market angle, this update confirms that BeOne is moving its oncology pipeline forward, which can support long-term growth narratives but is unlikely to shift earnings expectations in the near term. In early-stage oncology, stock reactions often hinge on whether programs advance without major safety issues and whether management signals confidence by expanding cohorts or adding combinations. Competitors in the solid tumor space, including larger oncology players, also run similar Phase 1 programs, so the key differentiator will be any early signs of strong activity or clean safety that could justify partnerships or accelerated paths. Investors should watch for dose-escalation progress and any early data disclosures, which could drive sentiment more than the mere fact that the study is recruiting.

The study is currently ongoing and updated, with further details available on the ClinicalTrials portal.

To learn more about ONC’s potential, visit the BeOne Medicines drug pipeline page.