Saint Paul

Researchers are studying metastatic castration-resistant prostate cancer mCRPC to find new treatment options. This trial evaluates if the study medicine ifinatamab deruxtecan I-DXd or MK-2400 helps people live longer overall and experience slower cancer growth or spread compared to chemotherapy. The study is a Phase 3 trial comparing I-DXd with standard chemotherapy for mCRPC patients. Participants are randomly assigned to receive either I-DXd at 12 mgkg every 3 weeks through intravenous infusion or docetaxel chemotherapy at 75 mgm2 every 3 weeks combined with daily prednisone pills. Treatment continues until the disease progresses, unacceptable side effects occur, or treatment is stopped for other reasons. Premedication is given before each dose of I-DXd to help prevent nausea and vomiting. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess overall survival and radiographic progression-free survival for up to about 36 months. Additional measures include response rates, time to pain progression, PSA progression, and adverse events. The study tracks safety, treatment effects, and quality of life over a long follow-up period to better understand the potential benefits and risks of I-DXd compared to chemotherapy.

Researchers are evaluating the safety, tolerability, and effectiveness of Navepegritide TransCon CNP in infants with genetically confirmed achondroplasia ACH who are younger than 2 years old. This Phase 2, multicenter, double-blind, randomized, placebo-controlled trial aims to compare weekly doses of Navepegritide with a placebo over a 52-week period to understand its impact on growth and safety in this population. Participants receive once-weekly subcutaneous injections of either 100 bcgkg Navepegritide or a placebo for 52 weeks. The study is randomized in a 21 ratio, with some infants receiving the active drug and others receiving placebo injections. After the 52-week treatment period, there is an open-label extension phase allowing continued evaluation. During the study, infants will be monitored through medical history reviews, physical exams, vital signs, ECGs, imaging, and lab tests to evaluate safety and growth changes. The main outcomes measured are the safety and tolerability of Navepegritide and its effect on growth over 52 weeks. Parents or caregivers will administer weekly injections and follow study instructions, including vitamin D supplementation where applicable. The total participation time includes the initial 52 weeks of treatment followed by further observation during the extension period.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab, both combined with platinum-based doublet chemotherapy, as a first-line treatment for patients with locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC whose tumors express PD-L1 at levels of 1% or higher. This Phase III, randomized, double-blind, global study aims to compare these treatments to improve outcomes for this patient group. Participants will receive either rilvegostomig or pembrolizumab, each given intravenously on Day 1 of every 21-day cycle, combined with platinum-based doublet chemotherapy either carboplatin or cisplatin also given on Day 1 of each cycle for up to four cycles. After chemotherapy cycles, patients continue with rilvegostomig or pembrolizumab monotherapy combined with pemetrexed maintenance. The study follows patients for up to approximately six years to monitor treatment effects and safety. During the study, participants undergo assessments including imaging scans to measure tumor size, blood tests to evaluate organ function, and questionnaires about symptoms and quality of life. Researchers monitor overall survival and progression-free survival as primary outcomes, alongside other measures such as response duration and physical functioning. Safety is closely observed throughout, with study visits scheduled regularly during treatment and follow-up periods, lasting up to six years in total.

Researchers are studying DB-1311BNT324 in adults with advanced solid tumors that have progressed after standard treatments or have no standard options available. This Phase 12a trial aims to evaluate the safety, tolerability, and early effectiveness of DB-1311BNT324, including its use alone or combined with new hormone therapies in prostate cancer. The study also investigates drug interactions with lopinavirritonavir and itraconazole. Participants receive intravenous doses of DB-1311BNT324 every three weeks at different dose levels to identify the best tolerated dose and recommended dose for further study. The trial includes various groups with specific tumor types, such as small cell lung cancer, non-small cell lung cancer, esophageal cancer, prostate cancer, melanoma, liver cancer, cervical cancer, ovarian cancer, head and neck cancer, and rare tumors. Some groups receive DB-1311BNT324 alone, while others receive it combined with oral hormone therapies or other drugs. During the study, participants undergo regular safety checks including vital signs, blood tests, heart function tests, and cancer status assessments. Researchers monitor side effects, serious adverse events, and tumor responses up to about one year after treatment. The main goal is to find the maximum tolerated dose and assess the drugs safety and preliminary antitumor activity. Participants health and cancer are closely followed throughout and after treatment.

Researchers are evaluating the safety and effectiveness of KarXT combined with KarX-EC in adults aged 55 to 90 who experience agitation related to Alzheimers Disease. This Phase 3 study aims to understand how these medications impact agitation symptoms in this population, using recognized criteria to confirm Alzheimers diagnosis and agitation severity. Participants will be randomly assigned to receive either the combination of KarXT and KarX-EC or a placebo. Dosing is specified for certain days, and the study includes a 14-week treatment period during which agitation and other symptoms will be closely monitored. The study design includes a quadruple-blind method to reduce bias. During the study, participants and their caregivers will attend regular visits where the researchers will assess changes in agitation using tools like the Cohen-Mansfield Agitation Inventory and Clinical Global Impressions-Severity scale. Safety will also be carefully monitored through various assessments including vital signs, lab tests, ECGs, and movement scales. Participant involvement extends up to 18 weeks to capture any adverse events and treatment effects.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are evaluating the efficacy, safety, and tolerability of elecoglipron compared with placebo in adults who have type 2 diabetes mellitus T2DM with impaired kidney function. Participants are also on dapagliflozin 10 mg as part of their guideline-directed medical therapy for chronic kidney disease CKD, along with other glucose-lowering medications. This Phase III study aims to understand how elecoglipron performs in this specific group of patients. Participants will be randomly assigned to one of three groups elecoglipron at dose level 1, elecoglipron at dose level 2, or placebo. All treatments are given orally once daily alongside background dapagliflozin 10 mg. The study uses a parallel design and includes a 40-week treatment period during which participants take their assigned medication. During the study, participants will have their blood sugar control measured through Hemoglobin A1c HbA1c levels from baseline to Week 40, which is the primary outcome. Additional assessments include body weight changes, blood pressure, fasting plasma glucose, and time to needing additional diabetes medication. Safety and tolerability will be monitored throughout the study, which lasts up to 40 weeks for each participant.

Researchers are conducting a Phase 3 pediatric study to create a framework for evaluating the safety and effectiveness of drugs for managing obesity or overweight conditions in children and teens. The study focuses on participants who have struggled to lose weight despite structured diet and exercise programs. The goal is to assess treatments for long-term weight management in this young population. Participants will receive either the study drug Orforglipron or a placebo orally. The interventions will be detailed in specific substudies, called ISAs, which may start independently as new treatments become available. Results from all ISAs will be reported once all are completed, providing insights into the treatments effects on pediatric obesity or overweight. During the study, participants will be evaluated from baseline to week 72, with the primary outcome measuring the number of participants assigned to each ISA. Participants will undergo assessments including body mass index evaluations based on age- and gender-specific growth charts, and monitoring for weight-related health conditions. Safety and efficacy data will be collected throughout the study duration, which extends to March 2027.

Researchers are evaluating the long-term clinical outcomes of anterior vertebral body tethering AVBT, a minimally invasive growth modulation technique recently approved by the FDA for treating scoliosis in skeletally immature children. The study focuses on how AVBT affects three-dimensional spine growth compared to normal controls, whether it maintains the major Cobb angle at or below 50 degrees at skeletal maturity, and the complications related to the procedure and device. Participants will undergo AVBT surgery as clinically indicated after completing all pre-operative assessments. This procedure aims to control curve progression by applying compression on the convex side of the spinal deformity. The study follows patients for up to five years to monitor spine growth, curve maintenance, and any complications associated with the surgery and the device. During the study, participants will have regular assessments to evaluate three-dimensional spine growth and spinal curve measurements. Researchers will compare these outcomes to those of normal controls and track any surgery or device-related complications over a five-year period. The study involves follow-up visits to ensure ongoing monitoring of participant health and treatment effects.

This trial enrolls participants from previous studies evaluating adagrasib either alone or combined with other cancer therapies in patients with non-small cell lung cancer, colorectal cancer, and other advanced solid tumors. It is an open-label continuation study designed to provide long-term treatment for cancer patients who have already participated in those parent trials. The study is sponsored by Mirati Therapeutics Inc. and focuses on treatment of solid tumors. Participants receive adagrasib and may also receive other cancer drugs such as pembrolizumab, cetuximab, pemetrexed, docetaxel, irinotecan, leucovorin, oxaliplatin, and fluorouracil. The dosing and schedule are specified but depend on the parent study protocols. This trial includes multiple experimental arms reflecting different treatment combinations or regimens, continuing treatment for eligible patients who showed clinical benefit in the parent studies. During the study, participants are monitored for adverse events up to 90 days after their last dose or if they discontinue treatment. Researchers track serious adverse events, treatment-related discontinuations, and deaths related to adverse events. Participation involves ongoing treatment and safety assessments, with the study lasting until the primary completion date in February 2028. The study does not include healthy volunteers and involves adults aged 18 years and older.