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Researchers are evaluating a new treatment called ifinatamab deruxtecan (I-DXd) for men with metastatic castration-resistant prostate cancer (mCRPC). This study compares I-DXd to chemotherapy to see if it helps people live longer overall and live longer without their cancer worsening. It is a Phase 3, open-label trial focused on patients who have progressed on prior therapies and have evidence of metastatic disease. Participants receive either I-DXd through an intravenous infusion every 3 weeks or docetaxel chemotherapy administered every 3 weeks. Prednisone tablets are also given daily as part of the treatment plan. Before each I-DXd dose, premedication is provided to help prevent nausea and vomiting using a combination of drugs such as corticosteroids and anti-nausea medicines. Treatment continues until disease progression, unacceptable side effects, or other reasons to stop. During the study, researchers monitor overall survival and how long patients live without their cancer progressing, for up to about 36 months. Participants undergo tumor tissue collection, scans, and assessments to track disease status and side effects. Safety is closely watched throughout treatment. The study includes men aged 18 and older with confirmed prostate cancer and metastatic disease who have previously received certain hormone therapies but no prior taxane chemotherapy for mCRPC.

Researchers are evaluating the safety, tolerability, and pharmacokinetics/pharmacodynamics (PK/PD) of LY3962681 in both healthy volunteers and patients with Parkinson's disease. This study includes a Single Ascending Dose (SAD) phase with healthy volunteers and a Multiple Ascending Dose (MAD) phase involving Parkinson's patients to better understand the effects of the drug administered into spinal fluid. The study is a Phase 1 trial designed to gather important safety and dosage information for LY3962681 compared to a placebo (artificial cerebrospinal fluid). The study consists of two parts: the SAD study where healthy volunteers receive a single dose of LY3962681 or placebo via intrathecal (IT) injection, and the MAD study where Parkinson's patients receive two doses of LY3962681 or placebo spaced 12 to 24 weeks apart, also by IT injection. The treatment period lasts one day in the SAD study and two days in the MAD study. Follow-up for both parts extends up to 52 weeks after the last dose to monitor participants. Participants will undergo medical evaluations, including cognitive assessments and specific Parkinson's disease diagnostic tests for patients. The study monitors serious and treatment-emergent adverse events, as well as discontinuations due to side effects, for up to 76 weeks. Throughout the study, researchers will closely observe participants' safety, tolerability, and the body's processing of the drug to determine its effects over time.

Researchers are evaluating whether the drugs retatrutide and tirzepatide can prevent major adverse liver outcomes (MALO) in adults with metabolic dysfunction-associated steatotic liver disease (MASLD) who are at high risk. This Phase 3 trial enrolls about 4,500 adults with MASLD identified by non-invasive tests indicating an increased likelihood of developing serious liver problems. The study aims to understand how these treatments might affect liver health over time compared to a placebo. Participants will be randomly assigned to receive either retatrutide, tirzepatide, or a placebo, all given by subcutaneous injection. The study will last approximately 224 weeks, during which participants may attend 25 to 30 clinic visits for monitoring and assessment. After the main study, eligible participants can join an optional 2-year extension where all will receive either retatrutide or tirzepatide regardless of their original group. Throughout the trial, participants’ liver function and disease progression will be closely monitored through various health assessments. Researchers will track the time to the first major adverse liver event as the main outcome. Safety and health status will be evaluated regularly during clinic visits, ensuring thorough observation over the long study period.

Researchers are evaluating ALPS12 in a phase I, open-label, multicenter trial for patients with extensive-stage small cell lung cancer. The study aims to assess the safety, tolerability, how the drug moves through the body, immune response to the drug, and its preliminary anti-tumor effects. The trial includes two main parts: a dose-escalation phase and an expansion phase. Participants receive ALPS12 through an intravenous infusion. During the dose-escalation part, the study focuses on identifying dose-limiting toxicities and the pharmacokinetic profile over a 21-day cycle. The expansion part evaluates the anti-tumor activity of ALPS12 at selected doses based on tumor response. Another drug, obinutuzumab, is also given as an intravenous infusion. The study treatment and assessments continue for approximately 42 months or until treatment discontinuation. Throughout the study, participants undergo monitoring for adverse events, immunogenicity, and tumor assessments using established criteria. Safety and tolerability are closely tracked from screening until the end of the study. Researchers collect data on how the drug affects the tumor and the body over time. The total participation duration may be up to about 42 months, including all treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of bomedemstat (MK-3543) compared with the best available therapy (BAT) in adults with essential thrombocythemia (ET) who have not responded well to or cannot tolerate hydroxyurea. This phase 3 clinical trial aims to determine if bomedemstat provides a better durable clinicohematologic response in these participants. Participants will receive either bomedemstat as an oral capsule or one of the best available therapies, including anagrelide (oral capsule), busulfan (oral tablet), interferon alfa or its pegylated forms (subcutaneous solution), or ruxolitinib (oral tablet). The study involves a randomized, open-label design where treatments are compared directly. Throughout the study, participants will be monitored for their hematologic response up to about 52 weeks. Assessments include platelet and neutrophil counts before starting treatment to ensure eligibility. Safety and efficacy are tracked to evaluate the long-term impact of the treatments on ET.

Researchers are evaluating repotrectinib in adults and adolescents with advanced or metastatic solid tumors that have specific gene rearrangements (ALK, ROS1, NTRK1, NTRK2, or NTRK3). The study includes a Phase 1 dose escalation to determine safe dosage levels and side effects, and a Phase 2 expansion to assess the drug's overall response rate in different patient groups. The trial also investigates the drug's effect on liver enzymes in a substudy and measures outcomes like duration of response and survival. The treatment involves oral repotrectinib capsules given to participants. Phase 1 focuses on finding the maximum tolerated dose and recommended dose for Phase 2 by monitoring toxicities within 28 days of dosing. Phase 2 enrolls subjects into six groups based on prior treatments and tumor gene status, including those who are new to ROS1 or TRK targeted therapies and those who have received previous therapies. Each group receives repotrectinib to evaluate its effects in their specific conditions. Participants will undergo assessments including tumor measurements by imaging reviewed independently, laboratory tests, and monitoring for side effects. Researchers will track dose-limiting toxicities, response rates over two to three years, and survival outcomes. Safety and tolerability are closely observed during treatment. The study requires ongoing follow-up, including confirmation of tumor gene status and evaluation of response and progression over time.

Researchers are evaluating new treatment options for people with proficient mismatch repair (pMMR) endometrial cancer (EC) that is advanced or has come back after prior treatment. This type of cancer starts in the lining of the uterus and is considered advanced when it has spread locally or to other body parts and cannot be removed by surgery. The study aims to compare the effectiveness of sacituzumab tirumotecan (sac-TMT), an antibody drug conjugate, combined with pembrolizumab versus pembrolizumab alone, to see which approach helps people live longer without the cancer worsening. Participants first receive an induction phase of six cycles, each lasting three weeks, of pembrolizumab combined with carboplatin and either paclitaxel or docetaxel through intravenous infusions. Those whose cancer does not progress after this phase enter the maintenance treatment phase, where they are randomly assigned to receive either pembrolizumab plus sac-TMT or pembrolizumab alone. If the cancer does progress, participants may enter a subsequent treatment phase and be randomly assigned to pembrolizumab plus sac-TMT or sac-TMT alone. During the study, researchers monitor participants for progression-free survival and overall survival for up to approximately 44 and 54 months, respectively. Participants undergo regular imaging, assessments, and laboratory tests to evaluate cancer status and treatment effects. The study also tracks safety and tolerability throughout all phases, providing a comprehensive follow-up to understand treatment impact over time.

Researchers are evaluating sacituzumab tirumotecan as a second-line treatment for female participants with recurrent or metastatic cervical cancer who have previously received platinum chemotherapy and anti-PD-1/PD-L1 therapy. This study has two phases: a safety run-in to assess the safety and efficacy of sacituzumab tirumotecan, followed by a Phase 3 portion comparing sacituzumab tirumotecan to treatment chosen by physicians. The study aims to determine if sacituzumab tirumotecan improves overall survival, especially in participants with high TROP2 expression. Participants will receive intravenous infusions of sacituzumab tirumotecan during the safety run-in phase. In the Phase 3 portion, participants are randomized to receive either sacituzumab tirumotecan or one of several physician-chosen treatments including pemetrexed, tisotumab vedotin, topotecan, vinorelbine, gemcitabine, or irinotecan, all given by IV infusion. This setup allows comparison of sacituzumab tirumotecan monotherapy against standard second-line therapies. Throughout the study, participants will undergo evaluations for tumor response, adverse events, and overall survival, with monitoring lasting up to approximately 51 months for the safety run-in and about 43 months for the Phase 3 portion. Researchers will use imaging and tumor tissue analysis to assess measurable disease and TROP2 expression. Safety and treatment tolerability will be closely observed, including tracking discontinuations due to adverse events.

Researchers are evaluating the safety and effectiveness of sacituzumab tirumotecan with or without bevacizumab compared to standard care in women with platinum-sensitive recurrent ovarian, fallopian tube, or primary peritoneal cancer. This phase 3 study aims to learn how well patients tolerate these treatments and whether they live longer without their cancer worsening. The study focuses on those who have already undergone second-line platinum-based chemotherapy and have specific cancer stages and types. Participants receive sacituzumab tirumotecan and may also receive bevacizumab through intravenous infusion. Before sacituzumab tirumotecan, rescue medications such as H1 and H2 receptor antagonists, acetaminophen, dexamethasone, and steroid mouthwash are given to help manage side effects. The study includes multiple treatment phases and compares these interventions to standard care. These treatments are administered under close medical supervision throughout the study. During the study, participants are monitored for adverse events and treatment tolerability over approximately six weeks in the first part, followed by progression-free survival tracking for up to about four years. Assessments include physical exams, performance status evaluations, and safety monitoring. Researchers also collect tumor tissue samples and conduct laboratory tests to evaluate treatment effects. The total participation time involves ongoing observation to measure safety and effectiveness outcomes.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.