Malvern East

Researchers are evaluating the safety, tolerability, how the body processes the drug, and early antitumor effects of BG-C137, an antibody-drug conjugate targeting FGFR2b, alone and combined with other anticancer drugs in people with advanced solid tumors. This study includes two phases: Phase 1a focuses on dose escalation and safety, while Phase 1b involves dose expansion. The trial is sponsored by BeOne Medicines, formerly BeiGene. Participants receive BG-C137 through intravenous infusion. In combination groups, anticancer agents are given either intravenously or orally. Phase 1a includes monotherapy dose escalation, safety expansion, and combination dose confirmation and safety expansion. Phase 1b focuses on dose expansion. The study will determine the maximum tolerated dose, recommended doses for expansion, and overall response rates over approximately two years. During the study, participants will undergo evaluations including safety monitoring for adverse events, pharmacokinetic and pharmacodynamic assessments, and tumor response measurements using RECIST v1.1 criteria. Researchers will collect tumor tissue samples to assess FGFR2b expression and other biomarkers. Participants' physical function, organ health, and prior treatments will be reviewed. The total study duration may last up to about two years, with close monitoring of side effects and treatment effects throughout.

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and early antitumor effects of the drug BG-75098 alone and combined with BGB-43395 and fulvestrant in adults with advanced solid tumors. The study focuses on participants with measurable disease and good performance status, including those with tumors resistant to previous treatments or who have limited options. This is a phase 1 trial conducted in two parts to explore appropriate dosing and effectiveness. The study is divided into two phases: Phase 1a Dose Escalation and Phase 1b Dose Expansion. BG-75098 and BGB-43395 are given orally, while fulvestrant is administered by intramuscular injection. In Phase 1a, doses of BG-75098 are increased gradually to find the maximum tolerated or administered dose, both alone and in combination with the other drugs. Phase 1b expands on this to assess the recommended doses and evaluate the treatment's impact on tumor response over up to two years. Participants will undergo regular monitoring throughout the study, including assessments of adverse events from the first dose up to 30 days after the last dose, and evaluations of tumor response by investigators. The study tracks safety and dosage levels for up to two years. Participants will receive various tests such as imaging, laboratory studies, and performance evaluations to measure treatment effects and safety. The total duration of involvement depends on the treatment phase and follow-up periods.

Researchers are evaluating the effectiveness of zanubrutinib combined with anti-CD20 antibodies compared to lenalidomide plus rituximab (R2) in adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL). The study aims to measure progression-free survival using independent review committees and established lymphoma response criteria based on PET/CT and CT imaging. Participants will receive zanubrutinib orally either as 160 mg twice daily or 320 mg once daily in continuous 28-day cycles. In the zanubrutinib plus rituximab group, rituximab is given intravenously at 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1 and Day 1 of Cycles 2 to 5, each cycle lasting 28 days. The comparator group receives lenalidomide orally at 20 mg daily on Days 1 to 21 of each 28-day cycle for 12 cycles, plus obinutuzumab intravenously at 1000 mg on Cycle 1 Days 1, 8, 15 and Cycles 2 to 6 Day 1. During the study, participants will undergo imaging assessments such as PET/CT and CT scans to evaluate disease progression. Researchers will monitor treatment response and safety over approximately 78 months. Progression-free survival is the primary outcome, measured by a blinded independent review committee. Participants are expected to have measurable disease and adequate organ function at enrollment, with ongoing assessments to track treatment effects and adverse events.

This research aims to evaluate the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). The study is a Phase 3, open-label, randomized trial sponsored by BeOne Medicines. The goal is to better understand treatment options for patients whose disease has returned or did not respond to earlier therapies involving cBTKi. Participants will receive either BGB-16673 or pirtobrutinib, both given orally. The study compares these two treatments to assess their safety and efficacy. The treatment period and dosing details are managed as per the trial protocol to evaluate the outcomes of each drug. The study includes ongoing monitoring and assessments to observe treatment effects over time. During the study, participants will be closely followed for up to approximately 3 years to measure progression-free survival, as assessed by an independent review committee. Researchers will conduct regular evaluations including imaging and laboratory tests to track disease status and safety. Participants' health will be monitored throughout the study to identify any side effects or changes in condition.

Researchers are evaluating the effectiveness and safety of a fixed-duration treatment combining sonrotoclax (BGB-11417) plus zanubrutinib (BGB-3111) compared to a fixed-duration treatment of venetoclax plus acalabrutinib in adults with previously untreated chronic lymphocytic leukemia (CLL). This Phase 3 study focuses on patients who have not received prior therapy and aims to compare these treatment options for this condition. The study carefully monitors disease progression and treatment response over time. Participants will receive oral medications in one of two groups: sonrotoclax plus zanubrutinib or venetoclax plus acalabrutinib. These treatments are taken by mouth, and the study lasts for a fixed duration, with no additional details on dosing schedules provided. The goal is to understand how these combinations work in treating CLL when given to patients who have not been treated before. During the study, participants will be regularly assessed through imaging tests such as CT or MRI scans to measure disease status. Researchers will track progression-free survival up to about 70 months and evaluate the rate of minimal residual disease with high sensitivity up to approximately 16 months. Participants must have adequate bone marrow and organ function and an ECOG performance score of 0 to 2. Safety and treatment effects will be closely monitored throughout the study.

Researchers are evaluating BG-C9074, a new antibody drug conjugate, alone and combined with other cancer treatments in patients with advanced solid tumors. This first-in-human study focuses on identifying safe doses, how the drug behaves in the body, and early signs of its ability to fight tumors. The trial includes patients with specific types of advanced cancers who have previously received standard treatments and have tumors that cannot be removed by surgery or cured by other therapies. Participants receive BG-C9074 delivered through intravenous infusion either alone or together with other anticancer drugs like tislelizumab or bevacizumab. The study includes dose-finding phases to determine the maximum tolerated dose and recommended doses for further study. Treatments are given over varying timelines, with some phases lasting up to three years to assess safety and response rates. Throughout the study, participants undergo regular monitoring for side effects and treatment responses, including scans to measure tumor changes. Researchers also collect safety data over about three years, tracking adverse events and serious adverse events. The trial measures overall response rates to the therapies and determines optimal dosing strategies to guide future research.

Researchers are evaluating BG-T187, an EGFR×MET trispecific antibody, alone and combined with other therapeutic agents in participants with advanced solid tumors. This first-in-human, Phase 1a/1b open-label, multicenter study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and early antitumor activity of these treatments in patients whose tumors are advanced, metastatic, and unresectable. Participants will receive BG-T187 administered subcutaneously, either alone or in combination with other agents given intravenously. The study includes dose escalation and dose expansion phases to identify maximum tolerated doses, recommended doses for expansion, and the best Phase 2 dose. Various therapeutic combinations will be explored during the approximately two-year study duration. During the study, participants will be closely monitored for adverse events, serious adverse events, and overall response rates. Researchers will evaluate pharmacokinetic and pharmacodynamic data, tumor response, and safety outcomes over about two years. The study also involves regular assessments of measurable lesions and organ function to ensure treatment safety and effectiveness.