Puyallup

Researchers are evaluating zanidatamab combined with chemotherapy to treat people with early-stage HER2-positive breast cancer. This Phase 2 study focuses on patients with Stage II or III invasive breast carcinoma that is confirmed to be HER2-positive. The purpose is to assess the safety and effectiveness of this combination treatment before surgery. Participants receive zanidatamab and chemotherapy drugs such as paclitaxel, docetaxel, carboplatin, trastuzumab, and pertuzumab, all administered intravenously. After completing neoadjuvant therapy, participants agree to undergo either a mastectomy or breast-conserving surgery. The study is open-label and conducted at multiple centers. During the study, researchers monitor the participants' response by measuring the number who achieve a pathological complete response within 8 months. They also ensure participants have adequate organ function, track heart function with imaging, and evaluate treatment safety. Participants are regularly assessed to support study goals and monitor any side effects.

Researchers are evaluating the safety and effectiveness of a combination therapy using amivantamab and olomorasib in adults with metastatic non-small cell lung cancer (NSCLC) that has a specific KRAS G12C mutation. This mutation involves a change in the KRAS gene within tumor cells, and the study aims to find the best dose of the combination therapy and how well it can slow or stop tumor growth in this patient group. The study is a Phase 1/2 trial focusing on participants who have already received prior treatments such as platinum-based chemotherapy and immunotherapy. The study involves administering amivantamab and olomorasib to participants to evaluate their combined effects. Participants must have measurable tumors that have not been previously treated with radiation and may include those with stable brain metastases under specific conditions. The trial allows participants who have had previous cancers if those cancers are unlikely to interfere with the study results. Treatment doses will be adjusted to find the recommended dose for Phase 2, and the study includes both dose-finding and efficacy evaluation phases. Participants will be monitored for adverse events and dose-limiting toxicities for up to about three years and two months. Researchers will assess the confirmed objective response rate to the therapy during this period. Eligibility evaluations include tumor measurements and clinical assessments such as performance status. Safety and treatment effects will be closely tracked throughout the study duration to understand the therapy's impact and tolerability in this patient population.

Researchers are evaluating treatments for participants with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantation. This Phase 3 study compares if the combination of belantamab mafodotin, lenalidomide, and dexamethasone (BRd) can extend progression-free survival or increase the number of participants achieving minimal residual disease negative status compared with the combination of daratumumab, lenalidomide, and dexamethasone (DRd). Participants will receive either BRd or DRd treatment. Belantamab mafodotin, lenalidomide, and dexamethasone will be administered in the BRd group, while daratumumab, lenalidomide, and dexamethasone will be given in the DRd group. The study will monitor participants over approximately 7 years to assess long-term outcomes. During the study, participants will undergo assessments to measure progression-free survival and minimal residual disease status. Researchers will collect clinical data, laboratory tests, and safety information throughout the treatment and follow-up periods. The total duration of participation may last up to about 7 years to evaluate long-term effects and outcomes of the treatments.

Researchers are evaluating the safety and effectiveness of Dato-DXd in patients with metastatic hormone receptor-positive, HER2 IHC 0 breast cancer that cannot be treated with chemotherapy. This Phase IIIb, multinational, open-label study focuses on patients whose cancer is locally advanced, inoperable, or metastatic and has not responded to endocrine therapy. About 100 participants will receive Dato-DXd at a dose of 6 mg/kg by intravenous infusion every 3 weeks, up to a maximum dose of 540 mg for those weighing 90 kg or more. Treatment will continue until the cancer progresses as assessed by imaging criteria (RECIST 1.1), unacceptable side effects occur, or the participant chooses to stop. Tumor biopsies and blood samples will be collected at baseline, during treatment, and at progression to study biomarkers. Tumor imaging will be done every 8 weeks for the first 48 weeks, then every 12 weeks thereafter until disease progression or new anticancer therapy starts. Participants will undergo regular evaluations including tumor imaging, laboratory tests, and biomarker analyses. The main outcome measured is progression-free survival, defined as the time from the first dose until cancer progression or death, assessed up to about 24 months. Safety and tolerability will be closely monitored throughout the study, which is expected to enroll over 18 months with data cutoff about 6 months after the last participant is dosed.

This research aims to evaluate the safety and effectiveness of a drug called DII235 in adults who have high levels of lipoprotein(a), a condition linked to lipoprotein disorder. The study focuses on adults aged 18 to 80 years who also have evidence of atherosclerotic cardiovascular disease or type 2 diabetes. This is a Phase 2 study designed to identify the best dose of DII235 and understand its impact on lipoprotein(a). Participants will be randomly assigned to receive either DII235 or a placebo in a controlled, double-blind manner to ensure unbiased results. The study involves administering DII235 or a saline placebo as solutions for injection. The trial is designed as a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study. Participants will receive different doses of DII235 or the placebo, and their responses will be compared over time to evaluate the drug's effects on lipoprotein(a) levels. The dosing and treatment schedules are carefully monitored to assess the safety, tolerability, and appropriate dosage levels of DII235. Participants will be followed and evaluated through various assessments, including measuring the percentage change from their baseline lipoprotein(a) levels between Day 60 and Day 180, and also between Day 60 and Day 360 for different doses. Safety and tolerability will be closely monitored throughout the study duration. The trial includes regular laboratory testing and clinical evaluations to track participant health and treatment response. Overall participation in the study spans several months to capture both short-term and longer-term effects of the treatment.

Researchers are evaluating a drug called sigvotatug vedotin alone and in combination with pembrolizumab, with or without chemotherapy, to determine its safety and effects in people with various advanced solid tumors. This Phase 1 study includes participants with specific cancers like non-small cell lung cancer, head and neck squamous cell cancer, HER2-negative breast cancer, esophageal cancers, ovarian cancer, and others. The trial aims to find out the side effects of sigvotatug vedotin and whether it can treat these solid tumors effectively. The study is divided into four parts. Part A focuses on finding the right dose of sigvotatug vedotin. Part B tests the safety and effectiveness of that dose. Parts C and D look at the safety and effectiveness of sigvotatug vedotin combined with pembrolizumab alone or with chemotherapy drugs carboplatin or cisplatin. Participants receive these drugs intravenously, with pembrolizumab given every 3 or 6 weeks and chemotherapy every 3 weeks depending on the drug. During the study, participants undergo tumor biopsies, physical exams, and disease assessments to monitor treatment effects. Researchers track side effects, lab abnormalities, and dose-limiting toxicities for up to 30-37 days after the last dose of sigvotatug vedotin, and for up to 3 years after pembrolizumab treatment. The study follows participants with regular safety monitoring and evaluations of tumor response throughout the trial.

Researchers are investigating the effects of QCZ484 in patients with mild to moderate hypertension. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to evaluate the efficacy, safety, and pharmacodynamics of QCZ484 compared to a placebo, using various doses administered subcutaneously every 6 months. Participants will receive multiple doses of QCZ484 or a saline placebo through subcutaneous injections over a 12-month treatment period. The study will carefully test different dose levels to identify the optimal dosing strategy for patients with hypertension. Throughout the study, participants will be monitored for changes in their mean 24-hour systolic blood pressure measured by ambulatory blood pressure monitoring at baseline and after 3 months. Safety and tolerability will also be assessed, including regular laboratory tests and clinical evaluations. The trial includes detailed assessments to ensure participants understand and comply with study procedures during the entire duration.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are evaluating the addition of olaparib, a PARP inhibitor, as maintenance therapy following surgery and chemotherapy in patients with pancreatic cancer that has been surgically removed and who have a pathogenic mutation in BRCA1, BRCA2, or PALB2 genes. This phase II randomized, double-blind study aims to determine if olaparib can improve relapse-free survival compared to placebo in these patients, who have completed perioperative chemotherapy and have no evidence of recurrent disease. Participants are randomly assigned to receive either olaparib or a placebo orally twice daily in 28-day cycles for up to 12 cycles, as long as there is no disease progression or unacceptable side effects. Throughout the treatment period, patients undergo imaging tests such as CT scans or MRI and blood sample collections. After completing the treatment cycles, patients are followed up at 30 days, every 4 months for the first year, and then every 6 months for up to 10 years after randomization to monitor their health and disease status. During the study, researchers assess relapse-free survival by documenting any return of cancer or death from 22 to 44 months after randomization. They also collect blood samples and perform imaging tests to monitor the disease and evaluate treatment effects. Safety is carefully monitored, and patients must have recovered from previous treatments before starting the study. The study includes long-term follow-up to observe survival outcomes and any differences based on genetic mutations or prior chemotherapy regimens.