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Researchers are evaluating 177Lu-BetaBart, a 177Lu-labeled anti-B7-H3 monoclonal antibody, in patients with various relapsed or refractory solid tumors that are locally advanced, inoperable, or metastatic. This Phase 1/2a study aims to understand the safety, tolerability, how the drug moves through and affects the body, and early signs of anti-tumor activity. Eligible participants include adults 18 and older with cancers such as castration-resistant prostate cancer, colorectal cancer, lung cancers, head and neck cancer, ovarian, cervical, endometrial, triple negative breast cancer, and esophageal squamous cell carcinoma who have shown disease progression after recent treatments. The study has two main parts: a Phase 1 dose escalation phase to find the maximum tolerated or recommended dose using a Bayesian design, and a Phase 2a dose expansion phase at that recommended dose to confirm safety and observe preliminary anti-tumor effects. Participants receive 177Lu-BetaBart through intravenous infusions every six weeks. Each phase includes a screening period, treatment and imaging period, and a safety and long-term follow-up period to closely monitor outcomes and side effects. During the study, participants undergo assessments including imaging for disease evaluation, laboratory tests for organ function and drug effects, and monitoring of side effects for up to 30 weeks. Key outcomes include determining the suitable dose for future studies, tracking adverse events, and measuring anti-tumor activity through objective response rates and biochemical responses in prostate cancer. Pharmacokinetics, radiation dosimetry, and biokinetics of the drug are also measured at specified time points. Safety and tolerability are evaluated continuously, with follow-up to monitor long-term effects and overall health.

Researchers are evaluating the safety and effectiveness of two drugs, 64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA, in men with prostate cancer that has spread and no longer responds to hormone-lowering treatments. This study focuses on cancers that express a protein called PSMA and aims to find safe and effective dosing while monitoring how the drugs behave in the body. Participants will go through different study phases. In the initial dosimetry phase, a single dose of 200 MBq of 64Cu-SAR-bisPSMA is given. Later phases involve receiving multiple doses of 64Cu-SAR-bisPSMA or 67Cu-SAR-bisPSMA, with doses and number of administrations varying by phase and participant group. The dose escalation phase tests increasing doses of 67Cu-SAR-bisPSMA, followed by a cohort expansion phase with up to six doses of the recommended 67Cu-SAR-bisPSMA dose. During the study, participants will undergo PET/CT scans to track drug distribution and dosimetry within 48 hours of dosing. Researchers will measure prostate-specific antigen (PSA) levels and radiographic responses over up to five years to evaluate treatment effects. Safety will be monitored through assessments of vital signs, ECGs, laboratory tests, and recording any adverse events. The total study duration can extend up to five years for long-term follow-up.

Researchers are studying the safety and effects of a medicine called Ritlecitinib for adults with moderate to severe hidradenitis suppurativa (HS), a condition causing long-lasting painful red skin lumps. The study focuses on participants who have not responded well to antibiotics or could not tolerate them. This is a phase 2, randomized, double-blind, placebo-controlled trial to evaluate how well Ritlecitinib works compared to a placebo. Participants will be randomly assigned to receive either Ritlecitinib or a placebo pill that looks the same but contains no medicine. Those in the treatment group will take an oral loading dose once daily for 8 weeks, followed by a maintenance dose once daily for another 8 weeks. The placebo group will receive matching placebo pills on the same schedule. The total study duration is about 16 weeks. During the study, participants will attend about 10 clinic visits including screening, Day 1, and follow-ups every 1, 2, or 4 weeks until week 16. At each visit, health status will be checked through physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will also use an electronic diary on their mobile phones to record daily medication intake and HS symptoms. The main measurement is the proportion of participants achieving a 50% reduction in HS symptoms by week 16. Safety and other symptom improvements will also be monitored.

Researchers are evaluating litifilimab (BIIB059), a monoclonal antibody, in adults with active cutaneous lupus erythematosus (CLE). This includes those with subacute or chronic CLE, with or without systemic lupus erythematosus (SLE), who have not responded well or tolerated antimalarial treatments. The study aims to assess how litifilimab affects skin disease activity using scoring tools such as CLA-IGA-R and CLASI, as well as its safety and impact on quality of life. The study has two parts: Part A and Part B. After screening, participants are randomly assigned to receive either litifilimab or a placebo injection under the skin every four weeks for 24 weeks in a double-blind setup. After this, all participants receive litifilimab for another 28 weeks. Those who finish may join a long-term extension study or enter a safety follow-up lasting up to 24 weeks. Treatment involves regular injections and monitoring during these periods. Participants will undergo assessments of skin symptoms, immune responses, and quality of life using questionnaires. Researchers will measure outcomes like the percentage of participants achieving low skin redness scores and significant reductions in skin disease activity. Safety monitoring continues through the study and follow-up, with total participation lasting up to 80 weeks.

Researchers are evaluating new treatment options for people with locally advanced or metastatic colorectal cancer that cannot be removed by surgery and has a specific gene mutation called KRAS G12C. This study aims to learn about the safety and tolerance of adding calderasib and cetuximab, two targeted therapies, to a chemotherapy regimen called mFOLFOX6. The study also compares how long participants live without their cancer growing or spreading when receiving the combination treatment versus standard chemotherapy with or without bevacizumab. The study has two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil given every two weeks. The other group will receive mFOLFOX6 chemotherapy every two weeks, with or without bevacizumab or a bevacizumab biosimilar, based on the investigator's choice. Treatment continues until certain criteria are met for stopping. Participants will be closely monitored through up to approximately 44 months or longer for side effects, treatment discontinuation, and how long their cancer remains stable without worsening. Researchers will also assess survival, quality of life using questionnaires, and response to treatment over several years. Safety and efficacy data will be collected throughout the study duration, which includes follow-up assessments up to 5 years.

Researchers are evaluating a new medicine called ifinatamab deruxtecan (I-DXd) for treating men with metastatic castration-resistant prostate cancer (mCRPC). The study aims to find out if people receiving I-DXd live longer overall and have longer periods without cancer growth or spread compared to those receiving chemotherapy. This is a Phase 3, open-label trial sponsored by Merck Sharp & Dohme LLC. Participants in the study will be randomly assigned to receive either I-DXd at a dose of 12 mg/kg every 3 weeks or a combination of docetaxel chemotherapy (75 mg/m² every 3 weeks) with daily prednisone. I-DXd is given by intravenous infusion every 3 weeks until the disease progresses or side effects prevent continued treatment. Premedication is given before I-DXd to help prevent nausea and vomiting. During the study, participants will be closely monitored for overall survival and radiographic progression-free survival for up to about 36 months. Researchers will also assess several other outcomes including response rates, time to progression, pain progression, prostate-specific antigen changes, and side effects. Safety and treatment tolerability will be tracked throughout, and participants’ health will be regularly evaluated with scans and other tests.

Researchers are investigating new treatments for Pulmonary Arterial Hypertension (PAH), a condition where the blood vessels in the lungs thicken and narrow, causing high blood pressure in the lungs and making it difficult for the heart to work properly. PAH can lead to breathing difficulties and reduced activity levels. While current treatments help manage symptoms, they do not stop the disease from progressing. Sotatercept is a study medicine designed to target specific proteins involved in PAH, and this long-term follow-up study aims to assess its safety and tolerability when used alongside standard PAH treatments over an extended period. Participants who have completed previous sotatercept PAH studies may join this open-label follow-up study. Those from blinded studies will start sotatercept at 0.3 mg/kg by subcutaneous injection every three weeks and may increase to 0.7 mg/kg. Participants from unblinded studies will continue their current dose and may also increase to 0.7 mg/kg. The study focuses on monitoring sotatercept use combined with background PAH therapy to observe long-term effects. Throughout the study, participants will undergo regular assessments including tracking adverse events, laboratory tests for blood and chemistry markers, body weight, blood pressure, and electrocardiograms up to approximately 7 years. Additional measurements include walking distance tests, heart function markers, and risk scores related to PAH. Safety monitoring and tolerance to the medication will be closely observed over time to better understand sotatercept’s long-term impact in managing PAH.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL), a fast-growing blood cancer affecting immature B-cells. This phase 2 study compares the effects of zilovertamab vedotin combined with R-CHP chemotherapy versus polatuzumab vedotin combined with R-CHP in people newly diagnosed with this type of lymphoma. The goal is to see if the cancer responds better to one treatment over the other. Participants will be randomly assigned to receive either zilovertamab vedotin or polatuzumab vedotin, both given by intravenous infusion on the first day of each 3-week cycle for up to six cycles (about 4 months). Alongside these drugs, participants will receive cyclophosphamide, doxorubicin, and rituximab or a rituximab biosimilar by IV infusion, plus prednisone or prednisolone orally for five days each cycle. Those with high-risk DLBCL may receive two additional cycles of rituximab or its biosimilar. During the study, participants will have scans and tests to measure cancer response using established criteria over up to 31 months. Researchers will also monitor survival rates, quality of life, and side effects for up to several years. Safety assessments and treatment adherence will be tracked throughout the study and follow-up periods, ensuring thorough evaluation of each treatment's impact.

Researchers are investigating new treatments for advanced ovarian cancer that is non-HRD positive. The study aims to find out if maintenance treatment with sacituzumab tirumotecan (sac-TMT), alone or combined with bevacizumab, helps people live longer without their cancer worsening compared to standard care. This is a phase 3 trial involving participants who have completed surgery and first-line platinum-based chemotherapy. Participants will be assigned randomly to one of two groups. One group will receive sac-TMT infusions every two weeks on days 1, 15, and 29 of a six-week cycle, potentially combined with bevacizumab infusions every three weeks on days 1 and 22 for up to 22 cycles. The other group will receive either bevacizumab alone on the same schedule or be observed without treatment, depending on their assigned standard care option. Treatment continues until cancer progression, unacceptable side effects, or other reasons to stop. During the trial, participants will have regular visits for treatment and monitoring, including assessments of cancer progression and side effects. Researchers will measure how long participants live without cancer worsening (progression-free survival) for up to about 49 months and monitor overall survival and quality of life for up to about 78 months. Various health questionnaires will be used to track physical function, symptoms, and well-being. Safety and treatment tolerability will also be carefully evaluated throughout the study period.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 years who have early symptomatic Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. The study is a phase III trial designed to compare trontinemab with a placebo to better understand its impact on cognitive decline in Alzheimer's patients. Participants will be randomly assigned to receive either intravenous (IV) trontinemab or an IV placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. Treatment and monitoring will continue for 72 weeks, during which various cognitive and biological measures will be assessed. Throughout the study, participants will undergo regular assessments including cognitive tests like the Clinical Dementia Rating, Sum of Boxes (CDR-SB), and the Mini-Mental State Examination (MMSE). Brain imaging scans such as amyloid and tau PET scans, as well as MRI, will be used to observe changes in brain pathology. Researchers will also monitor safety by tracking adverse events, infusion reactions, and the presence of antibodies against trontinemab. Participants will be supported by a study partner and will be closely followed during the entire study period.