West Perth

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Primary immune thrombocytopenia (ITP) is a condition in which the immune system mistakenly destroys platelets, the cells that help stop bleeding. This leads to a low platelet count, making it easier to bruise or bleed. The trial investigates the long-term safety, tolerability, and effectiveness of mezagitamab in adults with chronic primary ITP who have previously participated in certain mezagitamab studies. It also examines how the body processes mezagitamab over time. Participants who completed the previous mezagitamab studies TAK-079-3002 or TAK-079-1004 and meet specific criteria will receive mezagitamab as a subcutaneous injection during this continuation study. The study is open-label and multicenter, focusing on continued treatment based on protocol requirements. The medication is given under medical supervision, and participants return to the study clinic several times throughout the study. During their participation, individuals will undergo regular assessments including monitoring for treatment-emergent adverse events and serious adverse events up to approximately 108 weeks. Researchers will track safety by noting any adverse events that lead to permanent withdrawal from mezagitamab. The study includes physical evaluations, laboratory tests, and ongoing safety monitoring to understand how well participants tolerate the treatment and how effective it is over the long term.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

Researchers are evaluating the effectiveness and safety of pirtobrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study focuses on two parts: Part 1 tests three different doses of pirtobrutinib in participants who have had 1 to 3 prior treatments, including a covalent Bruton tyrosine kinase (BTK) inhibitor. Part 2 evaluates pirtobrutinib alone in participants who have not received prior treatment but have a specific genetic deletion called 17p. This is a phase 2, open-label, randomized study. Pirtobrutinib is given orally to participants in both study parts. Participants in Part 1 receive one of three dose levels, while those in Part 2 receive pirtobrutinib monotherapy. Part 1 participation lasts about 3 years, and Part 2 participation can last up to 2 years. The study compares the effects of different doses and treatment histories to better understand pirtobrutinib’s impact on CLL/SLL. Throughout the study, researchers monitor participants' overall response to treatment from the start up to 3 years. They assess safety and side effects, and participants are required to be able to swallow oral medication and have a performance status that allows them to participate. The study includes regular evaluations to determine how well the treatment controls the disease and to track any adverse events over the course of the study periods.

Chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) are types of blood cancers that can cause symptoms like enlarged lymph nodes, spleen, or liver, night sweats, weight loss, and fever. People with these conditions have shorter life expectancy, creating an urgent need for new treatments to extend life and control symptoms. This research evaluates the safety and effectiveness of a drug called BGB-16673 compared to other treatments chosen by doctors in participants previously treated with both Bruton tyrosine kinase inhibitors (BTKi) and B-cell leukemia/lymphoma 2 protein inhibitors (BCL2i). Participants with relapsed or refractory CLL or SLL will be randomly assigned to receive either BGB-16673 taken orally or one of the investigator's chosen treatments, which include idelalisib plus rituximab (for CLL only), bendamustine plus rituximab, or venetoclax plus rituximab retreatment. The study plans to include approximately 250 participants worldwide. Treatments are given according to the assigned group to compare how well each controls disease progression. During the study, researchers will monitor participants for about 36 months to measure progression-free survival, which is the length of time patients live without their disease worsening. Participants will undergo assessments including imaging and laboratory tests to evaluate their health and treatment response. Safety and effectiveness will be closely followed throughout the study period to better understand the potential benefits and risks of BGB-16673 compared to other treatment options.

Primary immune thrombocytopenia (ITP) is a condition where the immune system mistakenly destroys platelets, cells that help stop bleeding, leading to a low platelet count and increased risk of bruising or bleeding. This study is evaluating whether mezagitamab, given under the skin, can effectively maintain stable platelet counts in adults with chronic primary ITP compared to a placebo. The study is a Phase 3, randomized, double-blind trial designed to assess the efficacy and safety of mezagitamab in this patient population. Participants will receive mezagitamab injections or placebo injections administered subcutaneously for up to 6 months. Those who complete this study or do not respond to treatment by week 16 may have the option to join a continuation study to receive open-label mezagitamab if eligible. The study includes careful monitoring during treatment, with multiple visits to the study clinic throughout the treatment period. During the study, participants will undergo various assessments to monitor their platelet counts and overall health. Researchers will measure the percentage of participants who achieve a durable platelet response up to week 24. Safety and response to treatment will be regularly evaluated through clinical visits and laboratory tests. The total participation duration includes the initial treatment phase and potential extension in the continuation study for those who qualify.

Researchers are evaluating the effectiveness and safety of pirtobrutinib (LOXO-305) compared to ibrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The study includes participants who may have had prior treatment as well as treatment-nave participants with a specific genetic deletion (17p deletion). The study is a Phase 3, open-label, randomized trial designed to assess these treatments in different patient groups over varying durations. Participants receive either oral pirtobrutinib or oral ibrutinib. Part 1 compares these two drugs in participants with or without prior therapy, and participation can last up to six years. Part 2 focuses on pirtobrutinib alone in treatment-nave participants with 17p deletions, with participation lasting up to two years. The study carefully monitors responses to treatment, including complete and partial remissions. Throughout the study, participants undergo regular assessments to track their response to therapy, including measuring overall response rates from the start of treatment until disease progression or new treatments begin. Safety and organ function are monitored, and laboratory tests help evaluate blood counts and kidney function. The study aims to provide detailed information on how well the treatments work and their safety over the long term.

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.

Multiple myeloma is a cancer affecting plasma cells in the blood, usually found in bones and bone marrow, causing bone pain, fractures, infections, weak bones, and kidney failure. This research aims to evaluate the safety, effectiveness, and how the body processes an investigational drug called Etentamig in adults with multiple myeloma. The study includes participants with newly diagnosed, relapsed, or refractory multiple myeloma and is divided into four substudies to explore different patient groups and treatment combinations. Participants receive Etentamig through intravenous infusions either alone or combined with other treatments such as daratumumab, lenalidomide, dexamethasone, or carfilzomib. The study features dose escalation phases where doses are gradually increased, followed by dose expansion phases where the established doses are administered alone or with other drug combinations. Around 440 adults will join this study, which lasts approximately 130 months and is conducted at about 50 sites worldwide. Throughout the study, participants will attend regular clinic or hospital visits for medical assessments, blood tests, and side effect monitoring. Questionnaires will also be used to evaluate how the treatment affects participants. The primary focus is on tracking adverse events and dose-limiting toxicities over various periods depending on the substudy. This study may require a greater time and treatment commitment compared to standard care, ensuring close monitoring of safety and treatment responses.

Researchers are evaluating how well sonrotoclax combined with obinutuzumab or rituximab compares to venetoclax plus rituximab in treating adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This phase 3, open-label study will also assess the safety of these treatment combinations. The study is sponsored by BeOne Medicines, previously known as BeiGene, and involves multiple centers. Participants will receive one of the following treatments: sonrotoclax taken orally with intravenous obinutuzumab, sonrotoclax taken orally with intravenous rituximab, or venetoclax taken orally with intravenous rituximab. The treatments are given according to the study protocol, and participants are randomly assigned to one of these groups. The study monitors how these combinations work over time. During the study, participants will be regularly assessed through evaluations such as imaging, laboratory tests, and physical exams to monitor disease progression and treatment effects. Researchers will measure progression-free survival, which is how long participants live without disease worsening, with follow-up lasting up to about 51 months. Safety is also closely monitored to understand any side effects. The total duration of participation depends on the individual treatment and follow-up schedules.