Zion

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.

This research involves both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood and immune system. It focuses on using unlicensed cryopreserved cord blood units (CBUs) for transplantation, aiming to study how well these unlicensed CBUs support recovery after transplant. The study also looks at important outcomes such as infection transmission, infusion reactions, survival rates, and graft-versus-host disease. Participants will receive transplants using these unlicensed cord blood units as part of a multicenter access and distribution protocol. The study is conducted at multiple U.S. transplant centers under the care of transplant physicians. The transplantation process involves administering these CBUs to patients with hematologic malignancies and other relevant conditions. Patients will be monitored for neutrophil recovery at 60 and 100 days post-transplant to assess engraftment success. Researchers will also evaluate infection rates, serious infusion reactions, survival one year after transplant, and incidences of acute and chronic graft-versus-host disease. Platelet recovery will be tracked as well. The study involves regular assessments to follow patients’ health and transplant outcomes over time.

This research investigates how using cannabis (also known as marijuana, weed, or THC) affects the quality of life for patients with multiple myeloma who are undergoing chemotherapy. It aims to compare the experiences of cannabis users and non-users, focusing on potential benefits and harms related to cannabis use. The study uses specific tools like the Functional Assessment of Cancer Therapy-Multiple Myeloma (FACT-MM) and symptom assessments to better understand these effects over time. Participants are divided into two groups. One group completes surveys and provides blood samples regularly throughout the study, while healthcare providers complete separate surveys about their care practices. This observational study does not involve giving any new treatments but monitors patients receiving their usual cancer-directed therapies, including any cannabis use. During the study, patients complete questionnaires about their quality of life and symptoms, and medical professionals assess any side effects. The study measures outcomes over up to one year, tracking changes in quality of life and any therapeutic benefits or adverse effects linked to cannabis. Researchers monitor these factors through patient reports and medical evaluations to better understand the impact of cannabis in this patient group.

Researchers are evaluating the safety, tolerability, how the body processes, and the anti-tumor activity of a drug called BGB-B2033 alone and in combination with tislelizumab, with or without bevacizumab. This first-in-human Phase 1 study includes participants who have locally advanced or metastatic hepatocellular carcinoma, alpha-fetoprotein-producing gastric cancer, extragonadal yolk sac tumors or non-dysgerminomas, and glypican-3-positive squamous non-small cell lung cancer. Participants will receive BGB-B2033 through intravenous infusion either alone or combined with tislelizumab, and sometimes with bevacizumab given by intravenous infusion as well. The study evaluates different dosing levels to find the maximum tolerated dose and the recommended dose for Phase 2. Treatment will be monitored over approximately two years in various parts of the study. During the study, participants will have tumor tissue samples collected and undergo assessments including safety monitoring for adverse events, evaluations of tumor response by an independent review committee, and tests to understand drug effects and dosing. The study will measure overall response rates and track safety and tolerability over up to about two years, with ongoing monitoring of health and treatment effects.

Researchers are evaluating the safety and effectiveness of divarasib combined with pembrolizumab compared to pembrolizumab with pemetrexed and either carboplatin or cisplatin. The study focuses on adults with advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This is a Phase III trial aiming to improve first-line treatment options for these patients. Participants will receive one of two treatment combinations. One group will take divarasib orally once daily along with pembrolizumab given through an intravenous infusion every three weeks. The other group will receive pembrolizumab with pemetrexed and either carboplatin or cisplatin, all administered by intravenous infusion every three weeks. Treatment schedules and dosages are carefully monitored during the study. Throughout the study, participants will be regularly assessed for progression-free survival and overall survival, with follow-up lasting up to approximately five years. Researchers will perform various evaluations including tumor measurements and safety monitoring. This long-term observation helps to understand the treatments' effects and safety over time, supporting informed decisions for future lung cancer therapies.

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

This research evaluates two forms of carmustine, VI-0609 (carmustine with propylene glycol) and BiCNU (carmustine with ethanol), as part of the BEAM high-intensity chemotherapy conditioning regimen in adults with Hodgkin or Non-Hodgkin lymphoma undergoing autologous hematopoietic cell transplantation (AHCT). The study is a phase 2 multicenter trial comparing these two drug formulations to understand their effects in lymphoma treatment. Participants receive either VI-0609 or BiCNU within the BEAM chemotherapy regimen before undergoing AHCT. Both drug forms are administered as part of the conditioning process designed to prepare patients for the transplant by reducing lymphoma cells. The study closely monitors infusion-related reactions and toxicity levels during and after treatment. During the trial, participants are assessed for infusion-related toxicities within 24 hours after receiving the drug and for unacceptable toxicities from the start of the BEAM regimen through 30 days post-transplant. Researchers track clinical and laboratory results including heart and lung function, and monitor overall patient safety. The study includes follow-up to evaluate the treatment impact and patient recovery over time.

Researchers are evaluating the overall survival of males with chemotherapy-naefve metastatic castration-resistant prostate cancer (mCRPC). This phase 3 randomized study compares treatment with xaluritamig plus abiraterone to the investigator's choice of docetaxel, cabazitaxel, or abiraterone. Participants must have confirmed prostate adenocarcinoma with metastatic lesions and evidence of disease progression despite prior androgen receptor pathway inhibitor therapy. The study includes two treatment groups: one receiving intravenous xaluritamig combined with oral abiraterone acetate, and the other receiving the investigator's choice of chemotherapy drugs docetaxel or cabazitaxel administered intravenously, or abiraterone taken orally. Participants intended for cabazitaxel must have had up to six cycles of prior docetaxel in the metastatic hormone-sensitive setting. Treatments are administered per protocol during the randomized phase. Participants will be monitored for overall survival for up to approximately 51 months. Eligibility requires adequate organ function and good performance status. The study excludes those with prior chemotherapy in the mCRPC setting, certain prior therapies, unresolved toxicities, or CNS metastases. Researchers will assess survival outcomes along with safety and treatment tolerability throughout the study duration.

Researchers are evaluating two surgical procedures, bilateral salpingectomy and bilateral salpingo-oophorectomy, to see how well they reduce the risk of ovarian cancer in women who have BRCA1 gene mutations. The study aims to determine if removing just the fallopian tubes (bilateral salpingectomy) is almost as effective as removing both the fallopian tubes and ovaries (bilateral salpingo-oophorectomy) in lowering ovarian cancer risk. This trial also assesses symptoms related to estrogen loss, quality of life, sexual function, cancer-related distress, decision-making about surgery, and treatment side effects in these patients. Participants choose between two groups: one group undergoes bilateral salpingectomy and may have their ovaries removed later, while the other group undergoes bilateral salpingo-oophorectomy. Both groups receive pelvic or transvaginal ultrasounds or pelvic MRI scans during screening, and blood samples are collected throughout the trial. Ancillary studies include quality-of-life assessments and questionnaires. The study also collects tissue and blood samples for future research. After surgery, participants have follow-up visits at 10 to 60 days, then at 6, 12, and 24 months, and annually for up to 20 years. Researchers monitor the time until any high-grade serous carcinomas develop, specifically ovarian, primary peritoneal, or fallopian tube cancers. They also track menopausal symptoms, sexual function, quality of life, cancer distress, medical decisions about surgery, and any adverse events during this long-term follow-up.

Researchers are evaluating the safety and effectiveness of GDC-4198 alone and in combination with giredestrant compared to abemaciclib combined with giredestrant in participants with locally advanced or metastatic estrogen receptor-positive (ER+), HER2-negative breast cancer. The study includes two phases: Phase Ib focuses on assessing the safety and how the body processes GDC-4198 alone and with giredestrant, while Phase II compares the activity and safety of the combination of GDC-4198 plus giredestrant against abemaciclib plus giredestrant. Participants must have breast cancer that has progressed during or after treatment with a CDK4/6 inhibitor and approved endocrine therapy. During the study, participants will receive oral doses of GDC-4198, giredestrant, or abemaciclib depending on their assigned group. Phase Ib evaluates GDC-4198 alone and combined with giredestrant, while Phase II randomizes participants to receive either GDC-4198 plus giredestrant or abemaciclib plus giredestrant. Treatment cycles and dosing details are monitored throughout the study to assess safety and drug behavior. Participants will be monitored for adverse events and dose-limiting toxicities during the first 28 days of treatment in Phase Ib, with safety tracked up to 36 months. Phase II will measure progression-free survival over up to 36 months. Assessments include medical evaluations, safety monitoring, and tracking of disease progression. The overall participation time may last up to three years, with regular visits and evaluations to ensure participant safety and collect study data.