Visakhapatnam

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) with or without durvalumab compared to the investigator's choice chemotherapy combined with pembrolizumab in patients who have PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC). This Phase III, randomized, open-label, international study aims to see if adding durvalumab to Dato-DXd can help patients live longer without their cancer worsening or simply live longer compared to standard chemotherapy with pembrolizumab. The study also examines how the treatments and cancer impact patients' quality of life. Participants will be randomly assigned to one of three treatment groups: Dato-DXd plus durvalumab, Dato-DXd alone, or investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin) combined with pembrolizumab. All treatments are given by intravenous infusion. The study design includes stratification based on geographic location, disease-free interval history, and prior PD-1/PD-L1 treatment for early-stage TNBC. During the study, participants will have regular assessments to monitor their disease status using RECIST 1.1 criteria and undergo imaging reviewed by blinded independent central review. Researchers will track progression-free survival, quality of life, safety, and other health measures over an anticipated period of up to 33 months. Participants must provide tumor samples for PD-L1 testing, and safety monitoring will continue throughout the study.

Researchers are investigating whether ziltivekimab can treat people living with heart failure and inflammation. The study compares ziltivekimab, a new medicine not yet approved anywhere, to a placebo, an inactive substance that looks like the medicine but contains no active drug. Participants have an equal chance of receiving either treatment. The study is expected to last up to one year and four months and focuses on people with heart failure who also have systemic inflammation. Participants will receive either ziltivekimab or placebo by monthly injections under the skin. The doses are given once a month throughout the study period. The study lasts for 12 months of treatment following randomization, during which the effects of the medicine compared to placebo will be closely monitored. During the study, participants will undergo various assessments including a heart failure questionnaire called the Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure symptoms and physical function over the 12 months. Other evaluations may include walking tests and heart function tests. Safety and health will be monitored regularly to understand how participants respond to the treatments and to track any side effects or changes in heart failure symptoms.

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adult patients with relapsed advanced solid tumors. These tumors include non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer. Participants must have no available curative or life-prolonging treatments and have exhausted all effective local therapies. Participants will receive oral AUR107 once daily. The study uses a traditional 3+3 dose escalation design to assess safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The treatment period focuses on finding the best dose and assessing how the drug behaves in the body. During the study, participants will be monitored for dose limiting toxicities and treatment-related adverse events over 28 days. Researchers will evaluate pharmacokinetics parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and half-life at specified days. Safety assessments, disease measurements, and tolerability will be closely followed to understand the effects of AUR107.

Researchers are conducting a Phase 1, open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR108 in adult patients with relapsed advanced lymphomas. This study focuses on patients with Non-Hodgkin lymphoma and Hodgkin lymphoma who have exhausted effective local treatments and have no curative or life-prolonging options available. The trial uses a traditional 3+3 dose escalation design to evaluate AUR108 as a single oral agent. Participants will receive oral AUR108 with a schedule of dosing for 3 days followed by 4 days without dosing each week. The study includes dose escalation to determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The research will monitor treatment-related adverse events and measure drug levels and effects over time. During the study, participants will undergo safety assessments including monitoring for dose-limiting toxicities and treatment-related adverse events, pharmacokinetic evaluations at specified time points, and clinical evaluations for disease response. The study duration averages about one year with ongoing safety follow-up. Researchers will collect data on adverse events, drug concentration, and patient health to evaluate the treatment's safety and dosing parameters.

Researchers are evaluating the effectiveness, safety, and tolerability of a combination treatment including adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to a placebo combined with pembrolizumab and platinum-doublet chemotherapy. This study focuses on adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. The trial is a randomized, double-blind, phase 3 study designed to provide insights into treatment options for this specific lung cancer type. Participants receive either adagrasib plus pembrolizumab alongside platinum-doublet chemotherapy drugs such as carboplatin or cisplatin and pemetrexed, or they receive a placebo plus pembrolizumab and the same chemotherapy regimen. The dosages and schedules of these drugs are specified and administered on predetermined days. The trial compares these two treatment groups to understand better the impact of adding adagrasib to the existing pembrolizumab and chemotherapy treatment. Throughout the study, participants are closely monitored for progression-free survival and overall survival, assessed up to seven years using standardized criteria for tumor response. Regular imaging scans such as CT or MRI are used to measure disease status. Safety and tolerability are also evaluated during the study, with ongoing assessments to track adverse effects and treatment response. The total duration of follow-up allows for long-term observation of treatment outcomes and participant health.

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effectiveness of adding LY3537982 (olomorasib) to standard anti-cancer drugs compared to standard treatment alone in participants with untreated advanced non-small cell lung cancer (NSCLC) that has a specific KRAS G12C gene mutation. This pivotal Phase 3 trial includes participants with locally advanced or metastatic NSCLC and considers their programmed death-ligand 1 (PD-L1) expression levels. The study includes multiple parts: Dose Optimization, Part A, and Part B are randomized, while Safety Lead-In for Part B and Part C are non-randomized. Treatments being assessed include LY3537982 taken orally, pembrolizumab administered intravenously, and standard chemotherapy drugs such as cisplatin, carboplatin, and pemetrexed given intravenously. Participants receive these treatments according to their assigned groups based on their PD-L1 expression and tumor histology. Participants will be monitored with regular assessments including measuring disease progression, safety evaluations, and treatment emergent adverse events for up to approximately one year, with overall study participation potentially lasting up to three years depending on individual response and health status. Outcome measures focus on progression-free survival and safety, capturing any adverse events from the start of treatment until disease progression or death.

Researchers are evaluating the safety and effectiveness of tirzepatide in adult participants in India who have either type 2 diabetes or who are obese or overweight without type 2 diabetes. This Phase 4, open-label study aims to better understand how this medication works in these populations over approximately 46 weeks. Participants will receive tirzepatide as an injection under the skin (subcutaneous administration) throughout the study period. The study includes adults with type 2 diabetes who have had the condition for at least one year and meet specific blood sugar and body mass index (BMI) criteria, as well as adults who are obese or overweight without type 2 diabetes but with certain related health conditions. This is a single-arm study, meaning all participants receive tirzepatide without comparison to another treatment. During the 46 weeks of participation, researchers will monitor participants for any serious side effects related to the medication and assess its overall safety. Participants will undergo regular evaluations including physical health assessments and laboratory tests to track the effects of tirzepatide. The primary outcome is to count the number of participants experiencing serious adverse events considered related to the study drug from the start through week 46.

Researchers are evaluating the effectiveness and safety of T1695 compared to Ciclosporin in treating participants aged 4 to under 18 years with moderate to severe Vernal Keratoconjunctivitis (VKC). This phase 2 study focuses on individuals who have a high clinical severity of VKC based on the Bonini scale. The goal is to better understand how these two treatments perform in improving this eye condition. Participants will be assigned to receive either T1695 ophthalmic suspension or Ciclosporin ophthalmic emulsion. They will be required to instill the assigned medication as directed. Several diagnostic tests will be performed, including slit lamp examinations, assessment of far best corrected visual acuity (BCVA), and corneal fluorescein staining using a modified Oxford scale. Fluorescein dye will be used to evaluate the corneal staining to measure disease severity and treatment response. Throughout the study, participants will undergo regular eye examinations and visual acuity assessments. The primary outcome is the change in corneal fluorescein staining grade from baseline to Day 29 (Week 4) using the modified Oxford scale. Safety and any adverse effects will be closely monitored during the study period. The total participation age range is from 4 up to 17 years old, with informed consent obtained prior to enrollment.

This trial investigates the effectiveness of Pumitamig compared to Pembrolizumab in adults with advanced Non-Small Cell Lung Cancer (NSCLC) who have not received prior treatment and whose tumors express PD-L1 at 50% or higher. The study targets individuals with locally advanced or metastatic NSCLC, focusing on those with measurable disease and good performance status. It is a Phase 3 randomized, double-blind study designed to compare these two treatments as first-line options for this patient group. Participants will receive either Pumitamig or Pembrolizumab at specified doses on scheduled days. The treatments are given as monotherapy, meaning each participant receives only one of these drugs throughout the study. The study does not mention additional treatment phases or extensions, focusing on the direct comparison of these two drugs for initial treatment. Throughout the study, researchers will assess how long participants live without their cancer worsening, using standardized criteria over about three years. Overall survival will also be tracked for up to five years. Participants will be monitored regularly to evaluate their response to treatment and overall health. Safety and effectiveness outcomes will be gathered through medical assessments consistent with clinical trial standards for NSCLC.