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Researchers are evaluating the safety and potential benefits of VHB937 in people aged 50 to 85 years with early Alzheimer's disease, including those diagnosed with Mild Cognitive Impairment due to Alzheimer's or mild Alzheimer's disease. This Phase II, multicenter, randomized, double-blind, placebo-controlled study aims to assess how VHB937 affects memory, thinking abilities, daily activities, and brain changes, while also studying how the body processes and responds to the treatment. The study includes an initial 72-week double-blind phase followed by an extension period. Participants will receive either VHB937 solution for infusion or a placebo solution through infusion during the 72-week double-blind phase. The study compares these two groups to evaluate the effects and safety of VHB937 in early Alzheimer's disease. After the double-blind phase, participants may continue in an extension period for further observation. Treatment involves regular infusions under controlled conditions throughout the study. During the study, participants and their study partners will attend visits for assessments including memory and cognitive tests, evaluations of daily functioning, brain imaging, and biomarker analysis from cerebrospinal fluid or PET scans. Researchers will monitor safety, record any side effects, and track changes using the Clinical Dementia Rating scale (CDR) over 72 weeks. The study requires a reliable partner to accompany participants to visits, and overall participation includes monitoring during treatment and the extension phase to thoroughly assess VHB937's effects and safety.

Researchers are evaluating the safety and preliminary effectiveness of SAR445877, given alone or with other anticancer treatments, in adults aged 18 and older who have advanced, hard-to-remove, or metastatic solid tumors. This Phase 1/2 study includes multiple groups and aims to find appropriate doses and understand how well the treatment works, including combinations with cetuximab, ADG126, or bevacizumab. The study involves about 542 participants, including those in a Japan-specific group, reflecting a wide range of advanced solid tumor types. The study has two main parts. Part 1 focuses on dose escalation to identify safe and effective doses of SAR445877 given either every two weeks or weekly, alone or combined with other therapies. Part 2 involves expanding and optimizing doses to assess safety and early effectiveness in various tumor types and treatment combinations. Participants receive SAR445877 and other drugs by infusion. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping treatment. Participants will undergo screening for up to 28 days before starting treatment, then receive ongoing therapy with regular monitoring. Assessments include scans and tests to measure tumor response, safety evaluations for side effects including dose-limiting toxicities, and follow-up visits after treatment ends. The study tracks outcomes during treatment cycles and for up to two years in the expansion phase, with safety follow-up lasting 30 days after the last dose. Overall, the participation duration varies depending on individual course and response.

Researchers are evaluating the safety and tolerability of NKX019, an investigational allogeneic CD19-directed CAR natural killer (CAR NK) cell therapy, in participants with autoimmune diseases such as systemic sclerosis, idiopathic inflammatory myopathies, and antineutrophil cytoplasmic antibody-associated vasculitis. This Phase 1/2, open-label, multi-center, non-randomized study uses a dose escalation and dose expansion design to assess preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of NKX019 in these immune-mediated conditions. The study uses a "3+3" dose escalation design to determine recommended doses for further study. Participants receive a cycle that starts with lymphodepletion using fludarabine and cyclophosphamide (Flu/Cy), or cyclophosphamide alone if they are cytopenic, followed by three doses of NKX019. The trial includes multiple cohorts to enroll additional participants across different autoimmune disease indications and monitors treatment effects and safety throughout. Participants undergo screening and receive treatments under close observation. Researchers monitor safety outcomes including dose-limiting toxicities during the first 28 days after the initial NKX019 dose and treatment-emergent adverse events from the first dose until 30 days after the last treatment. The study collects data on clinical responses, laboratory tests, and immune effects throughout the treatment and follow-up periods, with participant involvement spanning screening, treatment, and safety monitoring phases.

This research aims to study the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug VX-670 in adults who have Myotonic Dystrophy Type 1 (DM1). The trial involves participants aged 18 to 64 years with a confirmed diagnosis of DM1, including a genetic test showing a specific CTG repeat count. The study is a Phase 1/2 trial designed to assess how the drug behaves and how well it is tolerated in this population. Participants will receive VX-670 or a placebo, both administered intravenously, in single and multiple dose escalations. The study is randomized, double-blind, and placebo-controlled to compare the effects of the drug against a non-active treatment. The treatment periods include initial dosing and extended follow-up to evaluate responses over time. During the study, researchers will monitor participants closely for any adverse events from the start up to 42 days in the initial phase and up to 168 days in the extended phase. Safety and tolerability will be the main focus, alongside collecting data on how the drug is processed by the body and its biological effects. Participants will undergo assessments to track these outcomes throughout their involvement in the trial.

Researchers are evaluating the effects of ASTX727 combined with iadademstat versus ASTX727 alone in patients with accelerated or blast phase Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), including subtypes like polycythemia vera and myelofibrosis. This phase II trial aims to compare the complete acute leukemia response rate within four 28-day treatment cycles and assess survival outcomes and transplant rates. The study also explores molecular changes and resistance pathways related to these treatments. Participants are randomly assigned to one of two groups: one receives ASTX727 alone, which is a combination of decitabine and cedazuridine taken orally once daily on days 1 through 5 of each cycle; the other group receives the same ASTX727 dosing plus iadademstat taken orally on days 1-5, 8-12, 15-19, and 22-26. Treatment cycles repeat every 28 days until disease progression or unacceptable side effects occur. The study includes a dose escalation phase before randomization. During the study, participants undergo buccal swab, blood sample collections, and bone marrow aspiration and biopsy to monitor disease and treatment effects. After stopping treatment for reasons other than disease progression, patients are followed up every three months; if stopping due to progression, follow-up occurs every six months. Researchers measure treatment response using established leukemia criteria and track safety and overall survival throughout the study.

Researchers are evaluating SEA-CD70, alone and combined with azacitidine, in adults with myeloid malignancies including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This phase 1, open-label study aims to find safe dosing levels, assess side effects, and explore whether these treatments work. The trial includes several parts, each focused on different patient groups and treatment combinations, including those who are relapsed, refractory, or untreated, and those unfit for standard chemotherapy. The study involves seven parts: dose-finding for SEA-CD70 alone (Part A) and with azacitidine (Part D), safety and tolerability expansions for SEA-CD70 monotherapy in MDS (Part B) and AML (Part C), and expansions for SEA-CD70 with azacitidine in untreated or relapsed/refractory MDS or MDS/AML (Parts E and F). Part G evaluates dosing and safety of SEA-CD70 with azacitidine and venetoclax in untreated AML patients unfit for standard chemotherapy. SEA-CD70 is given intravenously on days 1 and 15 of each cycle; azacitidine is administered subcutaneously or intravenously on days 1 through 7; venetoclax is taken orally daily with dose ramping. Participants will be monitored for side effects, laboratory abnormalities, and dose-limiting toxicities during and up to about two years after the last dose. Safety, tolerability, and antitumor activity will be evaluated through clinical assessments, laboratory tests, and patient monitoring throughout the study. The study duration varies by part, including dose escalation, expansion, and follow-up periods to assess long-term safety and efficacy outcomes.

Researchers are evaluating FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This trial aims to assess the safety, pharmacokinetics, and clinical effects of FMC-376 in patients whose tumors are locally advanced, unresectable, or metastatic. The study is conducted in three parts: Phase 1A (dose escalation), Phase 1B (dose expansion), and Phase 2 (cohort expansion), focusing on multiple dose levels in this patient population. Participants will receive FMC-376 as an oral capsule taken daily. The study explores different dosing schedules across the phases to determine optimal dosing and further evaluate the treatment's effects. The study is open-label, meaning both researchers and participants know which treatment is being administered. During the study, participants will be closely monitored for adverse events and dose limiting toxicities up to 21 days, with safety assessments continuing for approximately 24 months. Researchers will also assess pharmacokinetics and clinical activity of FMC-376. Participants must meet certain health and function criteria before and during the study to ensure safety and reliable results.

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Researchers are evaluating the safety, tolerability, and effectiveness of a drug called IBI363 in adults with advanced solid cancers that have not responded to previous treatments. This Phase 2, open-label study involves multiple centers and focuses on patients with melanoma, non-small cell lung cancer, colorectal cancer, and renal cell cancer. The goal is to better understand how well IBI363 works and how safe it is for these patients. IBI363 will be given as an intravenous infusion every two or three weeks. Participants will continue to receive the treatment until their disease worsens, they experience unacceptable side effects, they decide to stop, the treatment duration reaches 24 months, or another reason arises that requires stopping the study drug. This flexible treatment schedule allows close monitoring and adjustments as needed. During the study, participants will undergo regular assessments to monitor their response to treatment and safety, including evaluations over a period of up to two years to measure the objective response rate. Researchers will also observe side effects and overall wellbeing. The study includes ongoing follow-up to track how patients respond to IBI363 and to ensure their safety throughout the treatment period.

Researchers are evaluating the safety and effects of a medicine called Mevrometostat for treating adults with Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC), and Follicular Lymphoma (FL). This Phase 1 study includes three parts; Parts 1 and 2 have finished enrolling, while Part 3 is currently open and focuses on men with CRPC who have progressed after prior treatment. The study aims to understand the safety profile, toxicities, and preliminary effectiveness of Mevrometostat alone or combined with other treatments. Participants in Part 3 receive oral Mevrometostat and/or enzalutamide. Part 3 has two substudies: a Bioequivalence (BE) substudy where participants take three single doses of Mevrometostat in separate periods, and a Drug-Drug Interaction (DDI) substudy with two cohorts. Cohort 1 receives Mevrometostat twice daily and/or itraconazole once daily, while Cohort 2 receives Mevrometostat twice daily, enzalutamide once daily, and/or itraconazole once daily. After the assessment phase, all participants enter a maintenance phase taking Mevrometostat twice daily and enzalutamide once daily until their cancer no longer responds. Throughout the study, participants will have regular evaluations including monitoring for dose limiting toxicities, adverse events, laboratory abnormalities, vital signs, and disease response. The study will track radiographic progression-free survival until disease progression or death, up to approximately two years. This close monitoring aims to gather data on the safety, tolerability, and effects of the treatments over time.