Richmond

Researchers are evaluating the effectiveness of N-acetylcysteine NAC in improving treatment outcomes for people with alcohol use disorder. This phase 4, double-blind, randomized, placebo-controlled trial aims to address the limited efficacy of current medications for alcohol dependence and explore personalized medicine strategies based on individual differences. The study is sponsored by the University of Sydney and involves 280 participants who have heavy drinking habits and a desire to reduce or stop drinking. Participants will be randomly assigned to receive either NAC at a dose of 2400 mg per day administered as 600 mg capsules taken twice twice daily for a total of 12 weeks along with standard medical management, or a matched placebo with the same schedule and standard care. The trial uses quadruple masking to keep participants, care providers, investigators, and outcome assessors unaware of group assignments. Treatment lasts for 12 weeks, followed by monitoring. During the study, participants will be assessed over 24 weeks for outcomes including the number of heavy drinking days, changes in liver function, and absence of heavy drinking days. Researchers will conduct interviews and monitor adherence, cognition, and safety. Participants must have stable housing and be able to consent and complete research interviews in English. Safety monitoring includes exclusion of unstable medical or psychiatric conditions and pregnancy screening. The total study duration includes the 12 weeks of treatment and follow-up assessments to measure drinking behavior and liver function.

Researchers are evaluating DR-01, a non-fucosylated human immunoglobulin G1 monoclonal antibody, in adult patients with large granular lymphocytic leukemia or various cytotoxic lymphomas. This first-in-human, multicenter Phase 12 study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and anti-tumor activity of DR-01 in these patient populations. The study is sponsored by Dren Bio and involves sequential dose escalation and expansion cohorts to find the optimal treatment regimen. Participants will receive DR-01 at different starting doses ranging from 0.3 mgkg to 10 mgkg, following one of three dosing schedules during the first month bi-weekly dosing, dosing on days 1, 8, 15, and 29, or dosing on days 1-5, 15, and 29. After the first month, dosing continues monthly with doses adjusted up to 10 mgkg for up to 25 cycles. Dose escalation and de-escalation cohorts are included, and optimized dosing regimens are evaluated separately for leukemia and lymphoma subjects in expansion phases. Throughout the study, participants will be monitored for adverse events, dose-limiting toxicities, and overall response rates using disease-specific criteria. Safety and pharmacological assessments will occur up to 25 months, with special focus on the first 28 days for dose-limiting toxicities and up to 6 months for dose optimization. Participants will undergo regular evaluations including clinical assessments and tissue biopsies when applicable. The study aims to determine the best dosage while closely monitoring safety and treatment effects over two years.

Researchers are evaluating oral Nuvisertib TP-3654, a PIM inhibitor, in a Phase 12 open-label trial for patients with intermediate or high-risk primary or secondary myelofibrosis. The study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of Nuvisertib. Participants include those who have been previously treated with JAK inhibitors, those currently on ruxolitinib with suboptimal response, and patients treated with other JAK inhibitors except momelotinib. The trial includes three treatment arms Nuvisertib alone, Nuvisertib combined with ruxolitinib, and Nuvisertib combined with momelotinib. Patients will receive oral doses with dose escalation to determine safe and effective levels. Each arm enrolls specific patient groups based on prior treatments and response. The study monitors drug effects and interactions when used alone or in combination with other JAK inhibitors. Participants will be closely monitored for dose-limiting toxicities, adverse events, spleen volume reduction, symptom improvement, and other pharmacokinetic measures. Regular assessments include symptom scoring, imaging scans for spleen size, laboratory tests, and cardiac monitoring. The study duration and follow-up extend to evaluate both safety and preliminary activity, with careful tracking of treatment effects over time.

Ovarian cancer is a serious disease with a high number of new cases and deaths worldwide. This study evaluates the safety and disease activity changes of mirvetuximab soravtansine combined with carboplatin, bevacizumab, or bevacizumab alone in female participants with ovarian cancer confirmed to express folate receptor alpha FR. The trial is a Phase 2 study involving approximately 400 participants worldwide, assessing different treatment combinations given by intravenous infusion. Participants will be assigned to one of three substudies and receive treatment in groups called arms. Substudy 1 includes arms where participants receive one of two doses of mirvetuximab soravtansine with bevacizumab or bevacizumab alone. Substudy 2 involves mirvetuximab soravtansine with carboplatin followed by mirvetuximab soravtansine alone. Substudy 3 combines mirvetuximab soravtansine, bevacizumab, and carboplatin followed by mirvetuximab soravtansine with bevacizumab. Treatments are given by intravenous infusion, and the study duration ranges up to approximately 40 months depending on the substudy. Participants will attend regular visits at hospitals or clinics where they will receive infusions and undergo medical assessments including blood tests and scans. Researchers will monitor treatment-emergent adverse events, ocular events, overall response, progression-free survival, and other outcomes up to about 40 months. The study includes careful safety monitoring and evaluation of disease activity during and after treatment to assess the effects and safety of these drug combinations.

Researchers are evaluating surzetoclax, an investigational drug, alone or combined with other anti-myeloma agents, in adults with relapsed or refractory multiple myeloma MM. The study aims to assess safety and changes in disease activity, including adverse events and response to treatment. This phase 12 trial includes participants who have previously received multiple therapies and have limited treatment options. The study has two substudies. Substudy 1 has a dose escalation phase testing surzetoclax combined with daratumumab and dexamethasone, followed by a dose expansion phase where participants receive surzetoclax with daratumumab and dexamethasone or with daratumumab, pomalidomide, and dexamethasone. Substudy 2 involves Japanese participants receiving various doses of surzetoclax alone. The total duration of participation may last about 4.5 years. Participants will attend regular visits for medical assessments, blood tests, and monitoring of side effects throughout the study. Researchers will measure dose-limiting toxicities and adverse events up to approximately 4.5 years, along with response rates, progression-free survival, duration of response, and overall survival. The study includes frequent safety and disease activity checks to evaluate the treatments impact over time.

Researchers are evaluating elritercept for its ability to reduce the need for red blood cell RBC transfusions and its safety compared to epoetin alfa in adults with very low, low, or intermediate risk myelodysplastic syndromes MDS who require regular blood transfusions. The study aims to understand if elritercept improves tiredness, lowers transfusion burden, enhances quality of life, and elicits an immune response. Participants receive either elritercept or epoetin alfa injections. Elritercept is given as a subcutaneous injection starting at 3.75 mgkg every 4 weeks, with possible dose increases to 5.0 mgkg. Epoetin alfa is administered as a subcutaneous injection starting at 450 IUkg once weekly, with possible dose escalation up to 1050 IUkg. The study follows participants for approximately 5 years to monitor treatment effects and safety. During the trial, participants are regularly assessed for transfusion independence, hemoglobin levels, fatigue, quality of life, and hematological improvements. Researchers monitor blood samples for drug concentration and immune response. Safety is evaluated through medical history, lab tests, and adverse event tracking. The main outcome is the proportion of participants achieving RBC transfusion independence for at least 12 weeks during the first 24 weeks. The study uses questionnaires and clinical assessments to measure fatigue and quality of life.

Researchers are evaluating the effectiveness and safety of standard chemotherapy with or without the drug INCB161734 in participants who have metastatic pancreatic ductal adenocarcinoma PDAC with a KRAS G12D mutation and have not received prior treatment for metastatic disease. This phase 3 study compares two groups to understand whether adding INCB161734 to chemotherapy improves outcomes in this condition. Participants will receive either oral INCB161734 tablets combined with chemotherapy chosen by their doctor either mFOLFIRINOX or GemNabP or a placebo tablet combined with the same chemotherapy options. The treatments are given according to the study protocol, and the study is conducted in a randomized, double-blind design to fairly compare the effects of INCB161734 plus chemotherapy versus placebo plus chemotherapy. During the study, participants will be monitored for overall survival, progression-free survival, and tumor response up to about two to three years. Researchers will also assess treatment side effects, quality of life using questionnaires, and other health outcomes. Participants will have regular visits for assessments, and safety will be closely tracked throughout the study period, which lasts until the study completion date in 2029.

Researchers are evaluating the effectiveness of glofitamab alone compared to an investigators choice of treatments for adults with relapsed or refractory mantle cell lymphoma MCL. This phase III trial focuses on patients whose lymphoma has returned or not responded after previous treatments, including those who have received BTK inhibitors. The study aims to determine which treatment better controls the disease and improves patient outcomes. Participants in the glofitamab group will first receive two intravenous doses of obinutuzumab before starting glofitamab infusions every 21 days for up to 12 cycles. Those in the comparison group will receive either bendamustine plus rituximab for up to six 28-day cycles or rituximab combined with daily oral lenalidomide for 28-day cycles until their disease progresses. Tocilizumab may be given intravenously as needed to manage side effects like cytokine release syndrome. Throughout the study, participants will undergo regular assessments including scans to measure tumor size, blood tests, and quality of life questionnaires. The main measure is progression-free survival up to about 24 months, with additional evaluations of response rates, overall survival, symptom changes, and drug levels. Safety monitoring and long-term follow-up will occur during this period to track treatment effects and patient well-being.

Researchers are evaluating the efficacy and safety of SAR441566 in adults with moderate-to-severe ulcerative colitis, a chronic inflammatory bowel condition. This Phase 2, multinational, randomized, double-blind, placebo-controlled study aims to assess how different doses of SAR441566 affect clinical remission in participants. The study includes participants aged 18 to 75 years who have active moderate-to-severe ulcerative colitis confirmed by endoscopy and who have previously received treatment for the condition. Participants will be randomly assigned to receive one of three different dose regimens of SAR441566 or a matching placebo. The medication is administered orally as tablets. The study includes a screening period of up to 28 days, followed by a main treatment period lasting 52 weeks. This treatment period is divided into a 12-week induction phase and a 40-week maintenance phase, followed by a 2-week follow-up after treatment ends. Additionally, eligible participants may enter an open-label extension period lasting up to 40 weeks. During the study, participants will attend up to 12 visits in the main treatment phase and up to 8 visits during the open-label period. Researchers will assess clinical remission using the modified Mayo Score at Week 12, along with various secondary measures such as endoscopic remission, patient-reported outcomes, and safety evaluations. Blood samples will be taken to measure drug concentrations, and adverse events will be monitored throughout the study. The total participation duration can be up to 59 weeks, including screening, treatment, and follow-up.

Researchers are evaluating the safety and tolerability of elranatamab combined with iberdomide in patients with relapsed or refractory multiple myeloma, a cancer of plasma cells. This phase 1b study includes two parts the first part assesses safety and tolerability, while the second part determines the appropriate dose of this combination for patients whose disease has returned or not responded to prior treatments. Participants receive elranatamab as a shot under the skin and take iberdomide by mouth once daily for 21 days in each 28-day treatment cycle. The study includes a non-randomized dose escalation phase and a randomized dose assignment phase. Treatment continues until disease progression, unacceptable side effects, or participant choice to stop. Both parts of the study monitor participants closely for treatment effects. During the study, participants will have regular assessments including monitoring for side effects, laboratory tests, and evaluations of disease response and progression. The main outcomes include the number of participants with dose-limiting toxicities and adverse events related to treatment, measured during the first cycle and up to 90 days after the last dose. Long-term measures such as response rates, survival times, and drug concentrations will be followed for up to two years. This information will help understand treatment safety and appropriate dosing.