Fairway

Researchers are evaluating the safety and effects of a drug called VHB937 in people with early Alzheimers disease. This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study that lasts 72 weeks, followed by an extension phase. The study aims to see if VHB937 can safely improve memory, thinking abilities, daily activities, and brain changes in individuals diagnosed with mild cognitive impairment or mild Alzheimers disease confirmed by specific biomarkers. Participants will receive intravenous infusions of either a low dose or high dose of VHB937, or a placebo. The study groups are assigned randomly and neither the participant nor the researchers know who receives which treatment during the 72-week double-blind period. After this, there is an extension phase to continue monitoring participants. During the study, participants will have regular assessments including memory and cognitive tests, evaluations of daily living activities, brain imaging, and blood tests to track how the body processes the drug and its immune response. Safety will be monitored by recording any adverse events throughout the study, which can last up to about 63 months. The main outcome measured is the change in the Clinical Dementia Rating scale over 72 weeks.

Researchers are evaluating SAR445877, alone or combined with other anticancer therapies, in adults with advanced unresectable or metastatic solid tumors. This Phase 12, open-label study aims to assess the safety and preliminary effectiveness of SAR445877 in various solid tumor types where standard treatments are not suitable or have failed. The study includes about 542 participants across multiple cohorts and tumor types. The study has two parts Part 1 is a dose escalation phase to find the best doses of SAR445877 given intravenously either every 2 weeks or weekly, alone or with other drugs such as cetuximab, ADG126, or bevacizumab. Part 2 is a dose expansion and optimization phase to further evaluate safety and early efficacy of SAR445877 at selected doses in monotherapy and in combination therapy across different cancer types, including non-small cell lung cancer, hepatocellular carcinoma, gastric cancer, colorectal cancer, and melanoma. Participants will undergo a screening period up to 28 days before starting treatment, which continues until disease progression, unacceptable side effects, or withdrawal. After treatment ends, there is a follow-up period until progression, new therapy, death, or withdrawal. Assessments include monitoring for side effects and tumor response using standard criteria. Researchers will also study pharmacokinetics, presence of anti-drug antibodies, and survival outcomes over up to 2 years.

Researchers are evaluating NKX019, an investigational allogeneic CAR NK cell therapy targeting CD19, in adults with various autoimmune diseases. This Phase 12 open-label, multi-center study aims to assess the safety and tolerability of NKX019, as well as preliminary efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity. The study includes participants with systemic sclerosis, idiopathic inflammatory myopathies, ANCA-associated vasculitis, and rheumatoid arthritis. Participants undergo a dose escalation phase following a 33 design to find the recommended dose for further study. Treatment cycles include lymphodepletion with fludarabine and cyclophosphamide, or cyclophosphamide alone for those with low blood cell counts, followed by three doses of NKX019. The study will expand to enroll more participants across different autoimmune conditions based on dose findings. During the study, participants will be monitored closely for adverse events and dose-limiting toxicities, especially within the first 28 days after the first NKX019 dose. Follow-up evaluations include laboratory tests, assessments of lung and muscle function, and immune response tracking for up to two years post-infusion. Researchers will also assess the impact of treatment on background therapies and measure drug levels and immune responses over time.

Researchers are evaluating the safety, tolerability, and how the body processes and responds to VX-670 in adults with Myotonic Dystrophy Type 1 DM1. This study is a Phase 12 trial that compares different doses of VX-670 to placebo in people diagnosed with DM1 who have a confirmed genetic test showing a specific repeat in their DNA. Participants will be randomly assigned to receive either single or multiple doses of VX-670 or matching placebo. The study has two parts Part A focuses on single ascending doses, while Part B includes both single and multiple ascending doses. The dosing levels in Part B will be based on results from Part A. Both VX-670 and placebo are given as intravenous solutions. During the study, participants will be monitored for adverse events up to 42 days in Part A and 168 days in Part B to assess safety and tolerability. Researchers will measure drug concentrations in blood plasma and muscle at various time points, including baseline, days 15, and 120. Muscle biopsies will be used to analyze changes in gene splicing. The total participation duration varies by study part, with detailed monitoring of drug effects and safety throughout.

Researchers are evaluating a drug called SEA-CD70, alone and combined with azacitidine, to assess its safety and potential effects in adults with myelodysplastic syndrome MDS and acute myeloid leukemia AML. This phase 1, open-label study aims to find appropriate dosing and understand side effects and antitumor activity in participants with relapsed or refractory disease as well as previously untreated higher-risk cases. The trial is sponsored by Seagen, a subsidiary of Pfizer, and includes several parts to address different patient groups and treatment combinations. The study consists of seven parts dose escalation and expansion of SEA-CD70 monotherapy for relapsedrefractory MDS and AML dose-finding and expansion of SEA-CD70 combined with azacitidine for relapsedrefractory and untreated higher-risk MDS or MDSAML and dose-finding 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 treatment cycle, azacitidine is given either subcutaneously or intravenously on Days 1 through 7, and venetoclax is taken orally daily with dose ramping. Participants will undergo safety and tolerability assessments, laboratory tests, and pharmacokinetic analyses through approximately two years after the last dose. Researchers will monitor adverse events, dose-limiting toxicities, and laboratory abnormalities. Secondary measures include response rates, remission durations, survival rates, and drug concentration levels. The study evaluates how well participants tolerate the treatments and examines the drugs effects on disease progression over up to four years.

Researchers are evaluating the drug FMC-376 in adults with advanced solid tumors that have a specific KRAS G12C mutation. This clinical trial is designed in three parts Phase 1A dose escalation, Phase 1B dose expansion, and Phase 2 cohort expansion, to study various dose levels in participants with these tumors. The trial focuses on tumors that are locally advanced, unresectable, or metastatic, including types like non-small cell lung cancer, colorectal cancer, and pancreatic cancer. Participants will receive FMC-376 orally as a daily capsule in 21-day cycles during the dose escalation, dose expansion, and cohort expansion phases. The study does not include placebo or blinded treatments. The trial aims to assess the safety, pharmacokinetics how the drug is absorbed and processed, and clinical activity of FMC-376 at multiple dose levels. During the study, participants will be monitored closely for dose-limiting toxicities within the first 21 days and adverse events for approximately 24 months. Researchers will measure drug levels in the blood, response rates, duration of response, disease control, progression-free survival, and overall survival. Participants will undergo regular assessments including laboratory tests and evaluations to track safety and treatment effects throughout the study period.

Researchers are evaluating the antitumor activity of amivantamab combined with lazertinib or with chemotherapy in participants who have common EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC. This Phase 2b open-label study aims to understand how well these combinations work as first-line or second-line treatments for this type of lung cancer. Participants will be assigned to one of two groups one group will receive amivantamab combined with lazertinib orally in 28-day cycles, and the other group will receive amivantamab combined with platinum-based chemotherapy carboplatin and pemetrexed given by intravenous infusion in 21-day cycles. Treatment will continue until disease progression, withdrawal, death, or investigator decision to stop treatment. During the study, participants will undergo regular assessments including monitoring for progression-free survival up to 4 years and 6 months. Additional evaluations include tracking dose changes, adverse events, overall survival, response rates, and time to treatment discontinuation. Safety and clinical outcomes will be closely observed throughout the treatment period and follow-up.

Researchers are evaluating IBI363, a study drug, in adults with advanced solid cancers that have not responded to previous treatments. This Phase 2, open-label, multicenter trial aims to assess the drugs effectiveness, safety, and tolerability in people with melanoma, non-small cell lung cancer, colorectal cancer, and renal cell cancer. Participants will receive IBI363 as an intravenous infusion every two or three weeks. They will continue treatment until their disease worsens, they experience intolerable side effects, they choose to stop, the treatment duration reaches 24 months, or other reasons require stopping. The study does not include a placebo group and is open-label, meaning both researchers and participants know the treatment. During the study, participants will undergo regular assessments including monitoring of tumor response for up to two years and safety evaluations for adverse events up to 90 days after the last dose. Dose-limiting toxicities will be observed during specific time frames depending on the dosage schedule. Participants overall health and disease status will be closely followed throughout the trial period, which starts in April 2024 and ends in December 2026.

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of mevrometostat (PF-06821497) administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. The study consists of three parts (Part 1, Part 2, and Part 3) along with the Japan and China monotherapy cohorts. Part 1 and Part 2 are closed for enrollment. Part 1 tested monotherapy in 3 cohorts (Parts 1A, 1B, and 1C); Part 2 tested combination therapy in Parts 2A (dose escalation), 2B and 2C (does expansion). Part 3 consists of the Bioequivalence (BE) and drug-drug interaction (DDI) substudies and are open for enrollment. The BE substudy will test between 2 mevrometostat formulation to confirm that they work in the body the same way. The DDI substudy will evaluate the effect of a strong CYP3A4 (an enzyme in your body that breaks down/ removes drugs) inhibitor on the PK of mevrometostat; a strong CYP3A4 inhibitor may slow down the breakdown/ removal of drugs in your body. The Sponsor may choose to delay or discontinue any cohorts or substudies.

Researchers are evaluating the safety, tolerability, how the body processes, and early anti-tumor effects of new drugs or drug combinations given around the time of surgery in adults with locally advanced gastric, gastroesophageal junction GEJ, or esophageal adenocarcinoma who have not been treated before. This phase II, open-label study includes multiple sub-studies to assess different novel treatments. Participants are assigned to sub-studies based on the recommended dose determined by a safety review. Participants receive one of three treatment plans that combine novel drugs and chemotherapy before surgery neoadjuvant and after surgery adjuvant. One group receives AZD0901 plus Rilvegostomig with either 5-FU or Capecitabine another receives Trastuzumab Deruxtecan T-DXd plus Rilvegostomig with 5-FU or Capecitabine the third group receives Rilvegostomig plus FLOT chemotherapy. After initial combination therapy, all groups continue with Rilvegostomig alone in the adjuvant phase. Treatments are given through intravenous infusions or orally, depending on the drug. During the study, participants undergo surgery as planned and are monitored for side effects, tumor response, and survival outcomes up to 38 months. Researchers collect data on adverse events, tumor shrinkage, surgery success rates, event-free and disease-free survival, and overall survival. Blood samples are taken to measure drug levels and immune responses. Participants are followed closely to assess treatment safety and effectiveness throughout the study period.