Edgewood

Researchers are evaluating (Z)-endoxifen as a potential treatment for premenopausal women with estrogen receptor-positive (ER+) and HER2-negative breast cancer. This phase 2 open-label study includes two parts: a pharmacokinetic (PK) phase to understand how the body processes the drug and a treatment phase to assess the drug's effects on tumor growth. The study aims to see if (Z)-endoxifen can slow or stop tumor growth by measuring changes in a biomarker called Ki-67. Participants are premenopausal women who meet specific cancer and health criteria. Participants in the PK part will take (Z)-endoxifen capsules daily at varying doses (20 mg, 40 mg, or 80 mg). Some will also receive a monthly injection of goserelin, a drug that temporarily stops estrogen production in the ovaries. The treatment cohort will receive both (Z)-endoxifen and goserelin. Tumor tissue samples will be collected by breast biopsy after about 4 weeks to assess the Ki-67 biomarker. Participants showing tumor response may continue treatment for up to 24 weeks or until they undergo surgery. Throughout the study, participants will have blood draws to measure drug levels and tumor markers, breast biopsies, imaging scans, and safety assessments. The main outcomes include measuring (Z)-endoxifen levels after 4 weeks, the rate of Ki-67 reduction, and tumor response after 24 weeks. Study participation lasts up to 6 months, including treatment, surgery, and a follow-up visit one month after surgery.

Researchers are investigating new treatments for extensive-stage small cell lung cancer (ES-SCLC), a type of lung cancer that has spread within or beyond the lungs. This trial evaluates the safety and effectiveness of combining two study medicines, gocatamig and ifinatamab deruxtecan (I-DXd), with or without standard chemotherapy and immunotherapy. Gocatamig is a T-cell engager therapy that helps the immune system target cancer cells, while I-DXd is an antibody drug conjugate designed to deliver cancer-killing agents directly to tumor cells. Participants will receive different treatment combinations based on the study part and arm to which they are assigned. Treatments include intravenous administration of gocatamig, I-DXd, atezolizumab, carboplatin, and etoposide. Rescue medications may be given as needed to manage side effects such as cytokine release syndrome or infusion reactions. Participants may be assigned to various treatment groups either per investigator choice or randomized, with some receiving maintenance treatments after initial induction therapy. Throughout the study, participants will be monitored for safety, including the occurrence of adverse events and dose-limiting toxicities, for up to about 58 months. Researchers will also assess tumor response by measuring cancer size changes. Other evaluations include biopsies, imaging scans, and clinical assessments to determine how well participants tolerate the treatments and how their cancer responds. The total duration of participation and follow-up will vary depending on the study phase and treatment arm.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

Researchers are conducting an open-label Phase 1 study to evaluate the safety and tolerability of LNCB74, an antibody drug conjugate, in participants with advanced or metastatic solid tumors. The study aims to find the maximum tolerated dose and recommend a dose for Phase 2. Participants have advanced unresectable or metastatic solid tumors such as ovarian, breast, endometrial, biliary tract, or non-small cell lung cancer. Participants will receive LNCB74 intravenously in 21-day cycles. Treatment will continue unless there are unacceptable side effects or clear disease progression. This study includes dose escalation and dose expansion phases to assess different dosing levels. The study drug targets the B7-H4 protein and is given as monotherapy. During the study, participants will undergo assessments to monitor safety and determine the recommended Phase 2 dose over up to 24 months. Researchers will evaluate side effects, disease status, and organ function. Tumor tissue samples will be collected for analysis. Participants will be followed closely for adverse events and treatment response throughout the study duration.

Researchers are evaluating a personalized management strategy for people with symptoms suggesting coronary artery disease (CAD). The study compares this strategy, which uses AI-based software to analyze coronary plaque from CT scans, against the usual care based on current guidelines. The goal is to see if this new approach improves diagnosis certainty, risk factor control, and referral efficiency for invasive coronary angiography with appropriate percutaneous coronary intervention (PCI). This is a prospective, randomized, open-label trial focusing on symptomatic patients suspected of having CAD. Participants assigned to the personalized management group will undergo a coronary CT angiography (CCTA) at the start. The images from these scans are processed using Cleerly Labs and Cleerly ISCHEMIA software to assess coronary plaque. This information is used to guide medical and interventional treatment decisions. The usual care group will receive standard diagnostic and treatment approaches based on American Heart Association/American College of Cardiology guidelines. During the study, which lasts about one year, researchers will monitor participants to evaluate the effectiveness and efficiency of these management strategies. They will measure outcomes such as improved diagnosis certainty, better control of CAD risk factors, and more appropriate use of invasive procedures like PCI. Safety and adherence will also be followed throughout the study period to understand the overall impact of the personalized approach compared to usual care.

Researchers are evaluating a new approach to prevent cardiovascular events in patients at increased risk due to age and conditions like type 2 diabetes, prediabetes, or metabolic syndrome but without known symptomatic cardiovascular disease. The study compares a Cleerly Coronary Artery Disease (CAD) Staging System-based care strategy with standard risk factor-based care to see if the former can better reduce cardiovascular events. The Cleerly system uses imaging to visualize and quantify coronary artery disease and guides personalized treatment and education based on this assessment. The trial uses the Cleerly CAD Staging System device, which employs a proprietary algorithm to detect and stage coronary artery disease and generate a risk score to guide treatment decisions. Participants receive either this stage-based care or the usual care based on traditional risk factors. The study is prospective, randomized, and pragmatic, designed to follow patients over an average of 3.5 years to compare cardiovascular event outcomes between these two care approaches. Participants will be monitored through cardiovascular event tracking throughout the study period. Data collected includes imaging results, risk scores, and treatment adherence to evaluate the impact of the care strategies. The primary outcome is the comparison of cardiovascular event risk between the Cleerly stage-based care and risk factor-based care groups. The study also includes ongoing safety monitoring and personalized management by a cardiologist-led team via digital communication devices.

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.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

This research aims to compare intismeran autogene combined with pembrolizumab versus placebo with pembrolizumab as an additional treatment after surgery for people with stage II, IIIA, or IIIB (with nodal involvement) non-small cell lung cancer (NSCLC) that has been fully removed with clear margins. The study is a phase 3 trial investigating whether the combination including intismeran autogene improves disease-free survival compared to the placebo combination. Participants will receive either intismeran autogene by intramuscular injection plus pembrolizumab by intravenous infusion or a placebo injection plus pembrolizumab. The treatments are given after surgery and standard platinum-based chemotherapy. No more than 24 weeks can pass from surgery to the first pembrolizumab dose. The study evaluates these treatments as adjuvant therapy to reduce cancer recurrence. During the trial, researchers will monitor participants for disease-free survival for up to approximately 78 months. Participants undergo regular assessments including medical evaluations to track cancer status and treatment effects. The study excludes those with prior neoadjuvant therapy, certain infections, or other cancer treatments that might interfere. Safety and long-term outcomes are carefully observed throughout the study period.

Researchers are evaluating nemtabrutinib compared with the investigator's choice of ibrutinib or acalabrutinib in adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received any prior therapy. This Phase 3 study aims to determine if nemtabrutinib is not worse than ibrutinib or acalabrutinib in terms of objective response rate and if it is better regarding progression-free survival, both assessed using standardized disease criteria by independent review. Participants will be randomly assigned to receive one of the three oral treatments: nemtabrutinib, ibrutinib, or acalabrutinib. The study compares the effectiveness of nemtabrutinib against the other two drugs chosen by the investigator to treat first-line CLL/SLL. Treatment continues with monitoring over months to assess response and disease progression. During the study, participants will undergo evaluations based on the International Workshop on Chronic Lymphocytic Leukemia criteria, including blinded independent central reviews of their disease status. Researchers will track objective response rates up to about 33 months and progression-free survival up to around 104 months. Participants will also be monitored for safety and treatment adherence throughout the trial period.