Chisinau

Researchers are evaluating a medicine called MK-1045 in adults aged 18 to 75 who have systemic lupus erythematosus (SLE) or rheumatoid arthritis (RA). The study aims to learn about the safety of MK-1045 and how well people tolerate it at different doses. Participants with SLE must have had their diagnosis for at least 6 months and meet specific classification criteria while taking at least one background therapy. Those with RA must also have had their diagnosis for at least 6 months and meet established classification criteria. The study involves giving MK-1045 through an intravenous infusion. This is a Phase 1 dose escalation study, meaning participants receive increasing doses of the medicine to assess safety and how the body processes it. The study monitors participants over multiple parts; the first part observes adverse events up to about 12 weeks, and subsequent parts continue monitoring for up to approximately 52 weeks. Participants may discontinue the study drug if they experience adverse events. During the study, researchers will track adverse events and reasons for stopping the medicine, collect information on how the medicine behaves in the body, and monitor participants’ health throughout. Safety and tolerability are the main outcomes, and the study includes ongoing evaluations for up to a year after starting treatment. Participants will have regular check-ins to assess their condition and any side effects while using MK-1045.

Researchers are conducting a Phase I/II, multi-site, open-label study to evaluate the safety, effectiveness, and optimal dosing of the investigational treatments BNT323 combined with BNT327 in adults with advanced breast cancer. This includes those with hormone receptor-positive or negative types, HER2-positive, HER2-low, HER2-ultralow, HER2-null breast cancer, or triple-negative breast cancer. The study aims to understand how these treatments work alone and together in this patient population. The study has two parts: Part 1 involves dose escalation where participants with chemotherapy-pretreated advanced breast cancer receive BNT323 and BNT327 together to find the recommended Phase 2 dose. Part 2 is an expansion phase that tests the safety and effectiveness of the chosen dose, including randomized comparisons of combination therapy at different doses and monotherapies. Participants may be assigned to one of four treatment arms, with dosing administered via intravenous infusion. Participants will be monitored for dose-limiting toxicities during the first 21 days of treatment, as well as adverse events up to 90 days after the last dose. Tumor response will be assessed for up to 36 months. Evaluations include heart function tests, tumor imaging, safety assessments, and tracking of side effects. The study carefully monitors treatment safety, effectiveness, and participant health throughout the trial duration.

Researchers are evaluating a combination treatment using BNT326 and BNT327 in adults with advanced or metastatic non-small cell lung cancer (NSCLC), including those with relapsed, progressive, or treatment-nafve disease. This multi-site, open-label study includes dose-finding and dose-expansion phases to investigate the safety, tolerability, and preliminary effectiveness of this combination therapy. The study targets patients whose tumors are advanced, metastatic, or recurrent with no curative treatment options available and includes participants with different genomic alterations. The study is divided into several parts: Part 1 is a dose escalation phase to find safe dose levels of BNT326 with BNT327; Part 2a expands the dose to further evaluate safety and initial efficacy; Part 2b focuses on dose optimization and understanding the contributions of each component. Participants receive intravenous infusions of BNT326 and BNT327, with some cohorts possibly receiving additional treatments such as pembrolizumab or standard chemotherapy. Treatment continues until disease progression, unacceptable side effects, withdrawal, or a maximum of 24 months. Dose levels for certain cohorts are determined based on earlier phase data, and some parts include randomization to different treatment groups. Participants undergo a screening period before starting treatment, followed by treatment, safety follow-up, efficacy follow-up, and long-term survival monitoring, totaling about 36 months. Researchers assess dose-limiting toxicities within the first 21 days of treatment and monitor adverse events, treatment interruptions, and objective response rates up to 36 months. Tumor measurements, safety labs, imaging, and patient health status are regularly evaluated. The study tracks tolerability and efficacy while ensuring participant safety throughout treatment and follow-up.

Researchers are evaluating the safety and effectiveness of oral AP1189 combined with methotrexate (MTX) in adults with early rheumatoid arthritis (RA) who have not previously taken disease-modifying anti-rheumatic drugs (DMARDs). This phase II, randomized, double-blind, placebo-controlled study aims to understand how different doses of AP1189 affect disease activity and inflammation in participants with active RA symptoms. The study involves four groups of 60 participants each, receiving either AP1189 at doses of 40 mg, 70 mg, 100 mg, or a placebo, all alongside oral methotrexate. Treatments are given daily for 12 weeks. Participants will be randomly assigned to one of these groups to compare the dose response and safety of AP1189 combined with methotrexate versus methotrexate alone. Participants will attend scheduled visits to monitor their disease activity, safety, and tolerability of the treatment. Assessments include measuring changes in the Disease Activity Score 28 using C-Reactive Protein (DAS28-CRP) at week 12. The study also involves physical exams, joint assessments, blood tests for inflammation markers and antibodies, and safety monitoring. The total treatment period lasts 12 weeks, with ongoing evaluations throughout this time.

Researchers are investigating BGB-16673, a targeted protein degrader aimed at treating various B-cell cancers including marginal zone lymphoma, follicular lymphoma, mantle cell lymphoma, chronic lymphocytic leukemia, Waldenström macroglobulinemia, and diffuse large B-cell lymphoma. The study includes both Phase 1 and Phase 2 parts to determine safe and effective dosing and to evaluate the drug's response in patients. The trial is conducted under the new company name BeOne Medicines, previously known as BeiGene. The treatment involves oral administration of BGB-16673. Phase 1 focuses on dose escalation and safety expansion to identify the maximum tolerated dose and recommended dose for expansion over approximately 28 days to 3 years. Phase 2 includes expansion cohorts to assess overall response rates over about 3 years. Participants may have prior treatments including Bruton tyrosine kinase inhibitors and other anticancer therapies depending on their cancer type and study phase. Participants will be monitored closely with assessments of adverse events from the first dose until 30 days after the last dose or before starting new therapy, whichever comes first, for up to 47 weeks. The study measures tolerability, dosing recommendations, and treatment response. Eligibility assessments include performance status and measurable disease, with safety and response evaluations continuing through both phases for up to three years.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of WVE-007, a stereopure siRNA oligonucleotide, in adults living with overweight or obesity. This Phase 1 study focuses on adults aged 18 to 60 years who have a body mass index (BMI) between 28 and 35 kg/m2, aiming to understand how the drug behaves and is tolerated when given in increasing single doses. Participants will receive ascending single subcutaneous doses of WVE-007 or placebo under a randomized, double-blind, placebo-controlled design. The study carefully monitors the effects of these doses to assess safety and how the body processes the drug. The treatment period includes administration of the drug and observation for any reactions or effects, with dose adjustments as planned. Throughout the study, participants will undergo medical history reviews, physical exams, and clinical lab tests to monitor health status and any adverse events from the first day through the end of the study. The main measurement is the proportion of participants experiencing adverse events. This study helps inform the safety profile and biological activity of WVE-007 in adults with overweight or obesity over the course of the trial.

Researchers are evaluating the safety and tolerability of subcutaneous VIS171 combined with standard care in adults with autoimmune diseases such as Systemic Lupus Erythematosus (SLE), Alopecia Areata (AA), and immune-mediated Focal Segmental Glomerulosclerosis (FSGS). This is a Phase 1 open-label trial designed to study how the body processes VIS171, its immune effects, and any side effects over a period of up to 9 to 12 months for each participant. Participants will receive VIS171 as a subcutaneous injection along with their standard treatment. The trial includes specific groups based on their autoimmune condition and disease characteristics, such as confirmed SLE diagnosis, scalp involvement in AA, or prior biopsy and history of nephrotic syndrome for FSGS. The treatment period and follow-up will extend up to approximately 45 weeks, during which safety and immune responses are closely monitored. Throughout the study, participants will undergo assessments to track any treatment-emergent adverse events, their severity, and overall safety of VIS171. Researchers will also evaluate pharmacodynamics, pharmacokinetics, and immunogenicity. The study requires regular visits for laboratory tests, clinical evaluations, and adherence monitoring to ensure participant safety and collect comprehensive data over the trial duration.

Researchers are evaluating CRB-701, an antibody-drug conjugate targeting nectin-4, in adults with advanced solid tumors that express nectin-4. This Phase 1/2 clinical trial aims to find a safe and effective dose of CRB-701 and to determine which cancers might respond to this treatment. The study includes three parts focusing on safety, dosing, and effectiveness, especially for tumors resistant to other treatments or lacking standard therapies. The study is divided into three parts. Part A involves escalating doses of CRB-701 alone to identify the maximum tolerated dose and recommended dose for further study. Part B tests two dose levels of CRB-701 alone and combined with an anti-PD-1 checkpoint inhibitor to optimize dosing. Part C further explores CRB-701 alone or with anti-PD-1 in up to seven groups of participants. Treatments are given by intravenous infusion. Participants will attend clinic visits for infusions and undergo various tests including blood work, CT or MRI scans, and other assessments to monitor tumor response and safety. The main outcomes measured are dose safety, tolerability, and objective tumor response over periods ranging from 21 days to up to 6 months. Ongoing monitoring includes safety assessments and evaluation of treatment effects over time.

Researchers are evaluating plamotamab in adults with moderately to severely active rheumatoid arthritis (RA) to determine its safety, tolerability, how the body processes the drug (pharmacokinetics), how the drug affects the body (pharmacodynamics), and the immune response it may trigger. This Phase 1b open-label study involves about 68 participants assigned to different dose groups to optimize dosing. Participants will receive plamotamab by subcutaneous injection under the skin. The study is a dose-escalation trial where doses are adjusted to find the best balance between effectiveness and safety. This process helps understand how different doses perform in people with active RA. During the study, researchers will monitor participants through assessments including safety evaluations, laboratory tests, and tracking how the drug behaves in the body. They will measure outcomes up to 52 weeks to observe the drug’s effects and any side effects. Participants will be closely followed throughout the treatment period to ensure safety and tolerability.

Researchers are conducting a Phase 2, multicenter platform study to evaluate the safety and effectiveness of several investigational treatments for adults with moderately to severely active Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. The study focuses on assessing multiple experimental oral or injectable therapies to better understand their effects on these conditions. Participants will receive one of the study drugs, MT-501 or MT-201, as part of this evaluation. The study aims to gather data on how these treatments perform in terms of safety, how the body processes them (pharmacokinetics), and their biological effects (pharmacodynamics). Treatment effects will be measured over a period of up to 13 weeks. During the study, participants will be monitored for any side effects, serious adverse events, and laboratory test changes. Researchers will also assess the participants' clinical remission status and improvements seen through endoscopic evaluations at 12 to 13 weeks. The total involvement duration includes screening and treatment periods, with careful tracking of outcomes and safety throughout.