Amravati

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 investigating the safety and effectiveness of Dato-DXd combined with osimertinib or alone compared to platinum-based doublet chemotherapy in treating adults with epidermal growth factor receptor-mutated (EGFRm) locally advanced or metastatic non-small cell lung cancer (NSCLC). This Phase III, open-label study includes participants whose disease has worsened despite prior osimertinib treatment. The goal is to evaluate progression-free survival (PFS) over up to 2.5 years. Participants are randomly assigned to one of three groups: Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd and chemotherapy drugs (pemetrexed, carboplatin, or cisplatin) are given by intravenous infusion, while osimertinib is taken orally. Treatment continues until the cancer progresses based on imaging, unacceptable side effects occur, or other reasons require stopping treatment. After stopping the study drugs, participants will have an end-of-treatment visit within 35 days and safety follow-up about one month later. During the trial, researchers will monitor participants with radiological scans and assess progression-free survival. Safety evaluations will continue after treatment ends to detect any side effects. The study includes adults aged 18 to 130 years with good performance status and adequate organ function who have progressed on prior osimertinib therapy. The total study duration includes treatment and follow-up periods to ensure thorough assessment of treatment effects and safety.

Researchers are evaluating the safety of darolutamide combined with standard androgen deprivation therapy (ADT) in Indian men who have high-risk non-metastatic castration-resistant prostate cancer (nmCRPC). This type of prostate cancer does not spread to other parts of the body but progresses despite very low levels of male hormones called androgens. The study focuses on men whose prostate-specific antigen (PSA) levels rise quickly, indicating potential tumor growth. Darolutamide works by blocking androgens from attaching to cancer cell proteins, and this study aims to learn about its safety in Indian participants, comparing results to a previous study that did not include Indian patients. All participants will take darolutamide tablets orally twice daily, with a total daily dose of 1200 mg. They will continue standard ADT, which lowers androgen levels. Participants will visit the study center every 16 weeks until their cancer worsens, medical issues develop, they leave the study, or the study ends. If the trial stops, participants may continue darolutamide if it benefits them. During the study, researchers will collect blood and urine samples, perform physical exams, check vital signs, assess heart health with ECG, and evaluate daily living abilities using ECOG performance status. They will monitor medical problems called adverse events (AEs), including lab test results, physical findings, heart function, vital signs, and changes in daily living abilities over about 15 months. These safety and effectiveness results will help understand how darolutamide works in real-world conditions for this group.

Researchers are evaluating the safety and effectiveness of sovateltide (PMZ-1620, IRL-1620) as a potential treatment for acute cerebral ischemic stroke. This prospective, multicenter, randomized, double-blind, parallel phase IV study focuses on patients who have experienced a stroke caused by a blockage in the brain's blood flow. The study explores how sovateltide may support brain repair by activating neuronal progenitor cells, promoting new blood vessel growth, preventing cell death, and increasing cerebral blood flow after ischemia. Participants will be divided into two groups of 80 patients each. One group will receive intravenous sovateltide alongside standard stroke treatment, while the other group will receive normal saline with standard treatment. Sovateltide or saline will be administered in three doses as IV boluses on day 1, day 3, and day 6, with doses spaced about three hours apart on day 1. The entire study will last about 18 months, including approximately 15 months for patient enrollment. During the 3-month follow-up period, each participant will attend three study visits. Researchers will monitor safety by tracking adverse and serious adverse events and assessing laboratory tests, vital signs, and physical exams. Effectiveness will be evaluated using stroke-related scales such as the NIH Stroke Scale, Modified Rankin Scale, and Barthel Index. All participants or their representatives will provide informed consent, and statistical analyses will compare outcomes between the treatment and control groups.