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Researchers are evaluating the safety and preliminary effectiveness of T3011, a treatment given directly into tumors, alone and combined with pembrolizumab, an intravenous medication, in adults with advanced or metastatic solid tumors. This Phase 1/2a open-label study focuses on several types of cancers including melanoma, head and neck squamous cell carcinoma, sarcoma, cutaneous squamous cell carcinoma, and non-small cell lung cancer. The study aims to find the best dose of T3011 and understand its safety when used alone or with pembrolizumab. The study begins with a Phase 1 dose escalation to test increasing doses of T3011 using a 3+3 design. After determining the recommended dose, Phase 2a Part 1 will evaluate T3011 alone in different cancer types across multiple arms, while Phase 2a Part 2 will assess the combination of T3011 with pembrolizumab in participants with metastatic non-small cell lung cancer. T3011 is given as an intratumoral injection up to 4mL every two weeks, and pembrolizumab is given intravenously every three weeks when combined. A rollover arm allows participants whose disease progresses on T3011 alone to receive the combination treatment. Participants will be closely monitored for safety and treatment effects for up to two years from the first dose of T3011. Assessments include tumor measurements, biopsies, laboratory tests, and evaluation of adverse effects. The study records the tolerability of escalating doses and the combination treatment, tracking disease progression and response. Participants must attend scheduled visits for injections, monitoring, and evaluations throughout the study period.

Researchers are evaluating the safety, tolerability, and therapeutic effects of a combination treatment using BNT113 and pembrolizumab compared to pembrolizumab alone for patients with unresectable recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) that is positive for human papillomavirus 16 (HPV16+) and expresses the PD-L1 protein with a combined positive score of 1 or higher. This Phase II/III trial includes patients whose cancer cannot be treated with local therapies and who have not received prior systemic anticancer therapy for their current disease condition. The trial consists of two parts. Part A is a non-randomized Safety Run-In Phase to confirm the safety and tolerability of BNT113 combined with pembrolizumab at the selected dose. Part B is a randomized phase that compares BNT113 plus pembrolizumab against pembrolizumab alone as first-line treatment. Patients in Part A continue their treatment without randomization. Treatments are given by intravenous injection or infusion, and patients may receive either combination therapy or monotherapy for up to 24 months. There is also an optional pre-screening phase to test tumor samples for HPV16 DNA and PD-L1 expression before entering the main trial. Participants undergo regular assessments including tumor measurements based on RECIST 1.1 criteria confirmed by independent review. Researchers monitor treatment-emergent adverse events for up to 27 months in Part A and evaluate overall survival and progression-free survival for up to 48 months in Part B. Tumor tissue samples are collected before treatment to confirm eligibility. The study involves ongoing safety monitoring and efficacy evaluations throughout the treatment and follow-up periods.

Researchers are evaluating the safety and effectiveness of trontinemab in people aged 50 to 90 with early symptoms of Alzheimer's disease, ranging from mild cognitive impairment to mild dementia. This Phase III clinical trial focuses on those who show evidence of Alzheimer's pathology and have a recent history of cognitive decline. The study aims to measure changes in cognitive function over 72 weeks. Participants will be randomly assigned to receive either intravenous trontinemab or a placebo. The trial is designed as a double-blind, placebo-controlled study, meaning neither participants nor researchers know who receives the active drug or placebo. The treatment period lasts up to 72 weeks, during which participants will undergo various assessments to monitor their cognitive status and safety. During the study, participants will complete clinical tests including cognitive assessments and imaging such as MRI, PET scans, or cerebrospinal fluid analysis to confirm Alzheimer's pathology. A study partner will assist participants as needed. Researchers will track changes from the start of the study through week 72 using tools like the Clinical Dementia Rating. Safety monitoring and adherence to study procedures will also be closely observed throughout the trial.

Researchers are evaluating intratumoral ONM-501 alone and in combination with cemiplimab, a PD-1 checkpoint inhibitor, in patients with advanced solid tumors and lymphomas. This phase 1, multicenter, open-label study aims to find the maximum tolerated dose, minimum effective dose, and recommended dose for expansion of ONM-501. The study includes patients whose tumors are advanced, nonresectable, or recurrent, and for whom no standard therapy is available. The trial has three parts: monotherapy dose escalation, combination therapy dose finding, and combination therapy dose expansion in specific tumor types. ONM-501 is given as intratumoral injections once weekly for three weeks followed by three weeks without treatment, in 21-day cycles. Cemiplimab is administered intravenously at 350 mg every three weeks during the combination phases. The dose escalation uses accelerated titration and a "Rolling 6" enrollment method to allow staggered patient entry. Participants will be closely monitored for treatment-emergent adverse events, dose-limiting toxicities, and serious adverse events for up to about 24 months. Assessments include physical exams, laboratory tests, and tumor measurements. The expansion phase will enroll patients into one to three indication-specific groups based on the recommended doses found. Safety and tolerability will be key outcomes throughout the study duration.

Researchers are evaluating the long-term safety, tolerability, and lasting effects of ALKS 2680 tablets in adults aged 18 to 70 years with Narcolepsy Type 1, Narcolepsy Type 2, or Idiopathic Hypersomnia. This study continues from earlier trials and aims to monitor how well the treatment works and how safe it is over an extended period. Participants receive daily oral doses of ALKS 2680 tablets in varying strengths ranging from 4 mg to 18 mg. The study is an open-label, long-term extension, meaning all participants know they are receiving ALKS 2680 as they continue treatment after completing a prior parent study. The dose is administered once daily, and the study focuses on ongoing monitoring rather than comparing to a placebo. During the study, participants are regularly assessed for any treatment-emergent adverse events up to 100 weeks. Safety evaluations include clinical assessments, laboratory tests, and monitoring for any new health issues. Researchers track the ability to tolerate the medication and the durability of its effect on symptoms. This long-term follow-up helps ensure comprehensive understanding of the treatment's impact over time.

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are investigating how CDR132L, a potential new medicine, affects the structure and function of the heart in people living with heart failure with reduced or mildly reduced ejection fraction and left ventricular hypertrophy. This Phase 2 study compares CDR132L to a placebo, where participants receive either treatment randomly. The study aims to evaluate changes in a specific biomarker, microRNA-132-3p, over 24 weeks, with the total study duration lasting about 60 weeks. Participants will receive either CDR132L or a placebo through an intravenous infusion once every 4 weeks for a total of 48 weeks. The treatments are given under a double-blind design, meaning neither the participants nor the researchers know who receives which treatment until the study ends. This allows for a fair comparison of the effects of CDR132L versus placebo on heart structure and function. During the study, participants will undergo regular assessments including laboratory tests to measure heart-related biomarkers and imaging tests such as echocardiography to monitor heart structure and function. Researchers will track changes from baseline to week 24 in microRNA-132 levels and continue monitoring participants through the 60-week study period to evaluate safety and treatment effects. Ongoing clinical evaluations and safety checks will help ensure participant well-being throughout the trial.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating multiple treatment combinations in a Phase Ib/II, open-label, multicenter, randomized umbrella study for women with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+) breast cancer. The study focuses on three groups: those with HER2-negative breast cancer who progressed after treatment with cyclin-dependent kinase 4/6 inhibitors; those with HER2-positive breast cancer who progressed after standard anti-HER2 therapies; and those with HER2-negative, PIK3CA-mutated breast cancer resistant to endocrine therapy. The study is designed to allow new treatment arms to open, existing arms to close, or patient populations to change based on clinical activity or toxicity. Participants will receive various oral drugs including Giredestrant, Abemaciclib, Ipatasertib, Inavolisib, Ribociclib, Everolimus, Samuraciclib, Palbociclib, and intravenous drugs like Atezolizumab. One treatment arm includes a fixed-dose subcutaneous combination of pertuzumab and trastuzumab. Treatments are given in cycles of either 21 or 28 days and continue until unacceptable side effects or disease progression. Some arms have specific dosing schedules, such as daily oral doses or intravenous infusions on certain days of each cycle. During the study, participants will be monitored through assessments including tumor measurements using RECIST v1.1 criteria to evaluate response, and tracking of any adverse events according to standardized criteria for up to six years. Researchers will collect tumor specimens for biomarker testing and assess safety through clinical evaluations. The study measures the percentage of participants showing complete or partial tumor response and records treatment side effects from baseline until 30 days after the last dose.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.