Cluj Napoca

Researchers are evaluating if combining the medicines calderasib and subcutaneous pembrolizumab can more effectively treat people with non-small cell lung cancer NSCLC that has a KRAS G12C mutation. The study aims to find out whether patients receiving calderasib with pembrolizumab live longer without their cancer growing or spreading compared to those receiving pembrolizumab with chemotherapy. This is a Phase 3 clinical trial focusing on first-line treatment for advanced or metastatic nonsquamous NSCLC. Participants are assigned to one of two groups. One group receives subcutaneous pembrolizumab plus berahyaluronidase alfa every 6 weeks for up to 18 cycles about 2 years along with oral calderasib until treatment discontinuation criteria are met. The other group receives the same pembrolizumab and berahyaluronidase alfa regimen plus chemotherapy with pemetrexed and either carboplatin or cisplatin infusions during the early cycles. Treatment continues based on individual response and tolerability. During the study, participants will have regular visits for treatment and monitoring. Researchers will assess progression-free survival, overall survival, response rates, and quality of life using questionnaires and symptom scores over several years. Safety will be monitored through adverse event reporting. The trial lasts up to about 7 years with ongoing evaluation of health outcomes and side effects to understand the impact of these treatment combinations.

Researchers are studying treatments for locally advanced or metastatic colorectal cancer mCRC that cannot be removed by surgery and has a specific KRAS G12C gene mutation. This trial aims to evaluate if adding the targeted therapies calderasib and cetuximab to the standard chemotherapy regimen mFOLFOX6 can provide better outcomes compared to mFOLFOX6 with or without bevacizumab. The study focuses on the safety and tolerability of these combinations and whether they can help people live longer without their cancer growing or spreading. Participants will be assigned to one of two groups. One group will receive calderasib orally, cetuximab every two weeks, and mFOLFOX6 chemotherapy including oxaliplatin, leucovorin or levofolinate calcium, and 5-fluorouracil every two weeks. The other group will receive mFOLFOX6 chemotherapy with or without bevacizumab every two weeks, based on the investigators decision. Treatments will continue until certain stopping criteria are met. During the study, participants will be monitored for side effects and treatment tolerance, with regular assessments of cancer progression. Researchers will measure outcomes such as dose-limiting toxicities, adverse events, progression-free survival, and overall survival. Quality of life will also be evaluated through questionnaires. The study may last up to several years, with monitoring continuing for safety and effectiveness throughout the treatment period and follow-up.

Researchers are evaluating a study medicine called MK-1045 in adults with systemic lupus erythematosus SLE or rheumatoid arthritis RA. The main goal is to learn about the safety and tolerability of MK-1045 when given at different dose levels. This is a phase 1 clinical trial focused on treatment and led by Merck Sharp & Dohme LLC. Participants will receive MK-1045 through intravenous infusion. The study has three parts Part 1 involves single doses at various levels, Part 2 includes three step-up doses over three weeks as prime, step-up, and target doses, and Part 3 offers optional dose expansion with similar dosing. This sequential study uses randomized allocation without masking. During the study, participants will be monitored for adverse events and treatment discontinuations up to approximately 52 weeks depending on the study part. Researchers will also measure how the drug behaves in the body and its effect on peripheral B cell counts. Participants will have regular assessments including safety and pharmacokinetic evaluations throughout the study period, which runs up to July 2029.

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are investigating new treatments for high-risk, early-stage breast cancer, specifically targeting two types triple-negative breast cancer TNBC and hormone receptor-low positiveHER2-negative breast cancer. These cancers are characterized by low or no HER2 protein and low hormone receptor presence. The study aims to evaluate if adding sacituzumab tirumotecan sac-TMT to pembrolizumab and chemotherapy can better reduce cancer cells in tumors and lymph nodes and improve the length of time patients live without cancer progression compared to pembrolizumab with chemotherapy alone. Participants in this trial receive one of two treatment plans. One group gets sacituzumab tirumotecan intravenously every two weeks plus pembrolizumab every three weeks for 12 weeks, followed by pembrolizumab with carboplatin and paclitaxel for another 12 weeks. After 3 to 6 weeks, surgery and optional radiation therapy take place, followed by pembrolizumab for about 28 weeks. Participants with remaining disease may receive additional treatments chosen by their doctors, including olaparib, capecitabine, doxorubicin, epirubicin, or cyclophosphamide. The other group receives chemotherapy drugs carboplatin and paclitaxel with pembrolizumab initially, then pembrolizumab with cyclophosphamide and doxorubicin or epirubicin, followed by surgery, optional radiation, and pembrolizumab for about 28 weeks, with similar additional options for residual disease. During the study, participants undergo core needle biopsies, receive intravenous infusions of study drugs, and have surgery and possible radiation therapy. Researchers assess outcomes such as the percentage of participants with no detectable cancer cells at surgery pathological complete response, event-free survival up to about 92 months, and overall survival up to nearly 10 years. Quality of life and side effects are monitored through questionnaires and adverse event tracking. The study lasts several years, with various assessments throughout treatment and follow-up periods to gather comprehensive data on treatment effects and safety.

This research aims to evaluate elafibranor, a study drug, compared to a placebo in adults with Primary Biliary Cholangitis PBC and cirrhosis, a liver disease causing bile duct damage and scarring. The trial focuses on whether elafibranor can better prevent worsening of the disease, including progression leading to liver transplant or death, and also assesses long-term safety and symptom impact such as itching and tiredness. Participants will be randomly assigned to take either an 80 mg tablet of elafibranor or a matching placebo tablet once daily, orally, with or without food. This double-blind treatment period can last up to 3.5 years for each participant, with tablets taken at approximately the same time each morning. The study is designed to compare these two groups over the long term. During the study, participants will undergo regular assessments including physical exams, vital signs, electrocardiograms, laboratory tests, and symptom questionnaires at intervals up to 3.5 years. Researchers will measure liver function tests, symptom scales, liver stiffness, and clinical outcomes related to disease progression. Safety is monitored through adverse event tracking and laboratory parameters, with follow-up extending to four weeks after the last dose. Overall participation may last up to 3.5 years.

Researchers are evaluating whether retatrutide and tirzepatide can prevent major adverse liver outcomes in adults with metabolic dysfunction-associated steatotic liver disease MASLD who are at high risk based on non-invasive tests. This Phase 3 randomized controlled trial aims to assess these treatments compared to placebo in about 4,500 adults over approximately 224 weeks. The study is sponsored by Eli Lilly and Company and focuses on liver disease progression and related health measures. Participants will be randomly assigned to receive retatrutide, tirzepatide, or placebo, all administered by subcutaneous injection. The trial includes two placebo groups corresponding to each experimental drug. After completing the main study, eligible participants may join a 2-year extension where all will receive either retatrutide or tirzepatide regardless of their initial assignment. During the study, participants may attend around 25 to 30 clinic visits for health monitoring, study procedures, and assessments of liver function and disease status. Researchers will measure the time to major adverse liver outcomes, changes in liver fibrosis scores, liver stiffness, liver fat content, liver enzyme levels, body weight, and cardiovascular events. Monitoring will continue from baseline through study completion, with detailed evaluations at multiple timepoints including week 104.

Researchers are investigating CRB-701, an antibody-drug conjugate targeting nectin-4, in adult patients with advanced solid tumors that express this protein. This three-part, open-label Phase 12 trial aims to determine a safe and effective dose of CRB-701 and to understand which cancers might respond to this treatment. The study explores safety, pharmacokinetics, and efficacy to guide future cancer therapies. Participants will receive CRB-701 through intravenous infusion over 30 minutes. The trial includes several dosing groups that range from dose escalation to dose optimization, sometimes combined with an anti-PD-1 drug. Part A focuses on escalating doses to find the maximum tolerated dose, Part B tests dose levels alone or with anti-PD-1 to optimize treatment, and Part C explores the recommended dose in multiple tumor cohorts. During the study, participants will attend clinic visits for infusions and undergo blood tests, CT or MRI scans, and other assessments to monitor tumor response and safety. Researchers will measure the safety, tolerability, and objective response rate to evaluate the treatments effect on tumors over periods ranging from 21 days to up to 6 months. The total study duration and monitoring will capture data on efficacy and side effects to support further research.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of increasing doses of WVE-007, a stereopure siRNA oligonucleotide, in adults living with overweight or obesity. The study includes two parts Part A focuses on single ascending doses in adults with overweight or obesity, and Part B involves repeated doses in two groups of adults with obesity who have pre-Type 2 diabetes or Type 2 diabetes. This Phase 12a study is randomized, double-blind, and placebo-controlled to carefully assess the investigational treatment.

Researchers are studying budoprutug, an investigational humanized antibody that targets CD19 cells, in adults aged 18 to 65 with active and seropositive systemic lupus erythematosus SLE who have not responded adequately to standard treatments. This Phase 1b open-label study focuses on assessing the safety and tolerability of budoprutug, as well as its behavior in the body and early signs of effectiveness. Participants will receive a single intravenous infusion of budoprutug at one of several ascending dose levels. The study will monitor how the drug affects B cell counts and antibody levels in the blood over time following the infusion. Multiple dose groups will be evaluated to understand safety and the drugs movement and action in the body. Throughout the study, participants will be closely observed for treatment-emergent adverse events and changes in vital signs and laboratory tests up to 24 weeks after dosing. Researchers will also measure budoprutugs concentration in the blood and immune responses, including the presence of anti-drug antibodies. The total monitoring period helps ensure comprehensive safety and pharmacological data collection.