Amravati

Researchers are evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of an oral drug called AUR108 in adult patients with relapsed advanced lymphomas, including Non-Hodgkin and Hodgkin lymphoma. This Phase 1, open-label, first-in-human study focuses on patients who have no available curative or life-prolonging treatments left and have exhausted all effective local therapies. The study uses a traditional dose-escalation design to determine the best dose of AUR108 based on safety and biological data. Participants will receive AUR108 orally with doses planned at 50, 90, 150, 220, and 300 mg in a cycle of 3 days of dosing followed by 4 days off each week. The study follows a 33 dose-escalation method to evaluate safety and drug behavior in the body and to select the optimal biological dose. This is a multicenter trial with dose expansion planned after the initial dose-escalation phase. During the study, participants will be closely monitored for dose-limiting toxicities during the first 28-day cycle and treatment-related adverse events throughout the trial, which may last about a year. Researchers will collect blood samples to measure drug levels and effects at multiple time points, including days 1, 8, and 17. Participants will undergo safety assessments, organ function tests, and evaluations of their lymphoma status to track treatment impact and side effects over time.

Researchers are evaluating the effects of Dato-DXd combined with osimertinib or Dato-DXd alone compared to platinum-based doublet chemotherapy in people with EGFR-mutated locally advanced or metastatic non-small cell lung cancer NSCLC whose disease progressed after prior osimertinib treatment. This Phase III, open-label, randomized study aims to compare progression-free survival among these treatments to better understand options for this condition. Participants are randomly assigned to one of three groups Dato-DXd plus osimertinib, Dato-DXd alone, or platinum-based doublet chemotherapy. Dato-DXd is given as an intravenous infusion every 3 weeks, osimertinib is taken orally daily, and chemotherapy involves pemetrexed combined with carboplatin or cisplatin every 3 weeks for four cycles, followed by maintenance pemetrexed. Treatments continue until disease progression, unacceptable side effects, or other reasons to stop. Throughout the study, participants undergo regular assessments including radiological scans to monitor tumor response using RECIST v1.1 criteria, safety evaluations, and health status measurements. After stopping treatment, an end-of-treatment visit occurs within 35 days, followed by safety follow-up 28 days after the last dose. The study primarily measures progression-free survival over up to 2.5 years, with additional outcomes including overall survival, response rates, quality of life, and pharmacokinetics monitored for up to 3.5 years.

Researchers are evaluating the safety and effectiveness of darolutamide alongside standard androgen deprivation therapy ADT in Indian men with high-risk non-metastatic castration-resistant prostate cancer nmCRPC. This type of prostate cancer continues to progress despite very low testosterone levels. The study aims to collect detailed safety data and compare it with previous research involving darolutamide, which did not include Indian participants. Participants will take darolutamide tablets orally twice daily along with their ongoing ADT. They will have visits every 16 weeks from the start until their cancer worsens, they develop medical issues, leave the study, or the study ends. During these visits, various tests and assessments will be performed, including blood and urine sampling, physical exams, heart activity monitoring with ECG, and evaluation of daily living abilities using the ECOG performance status. Throughout the study, researchers will monitor adverse events, lab abnormalities, vital signs, and changes in participants health status up to approximately 15 months. They will also assess changes in prostate-specific antigen PSA levels and track the time to additional cancer treatments. Participants may continue darolutamide after the trial if they benefit from it. The total study duration extends up to the primary completion date in April 2027.

Researchers are evaluating the safety and effectiveness of sovateltide also known as PMZ-1620 or IRL-1620 as a potential treatment for acute cerebral ischemic stroke. This phase IV, multicenter, randomized, double-blind study focuses on adults aged 18 to 78 who have experienced an ischemic stroke confirmed by imaging. Sovateltide is being studied because it may activate brain stem cells, promote new neuron and blood vessel growth, prevent cell death, and improve blood flow after stroke, all of which could help brain repair and recovery. The study involves 160 patients split into two groups. One group receives three intravenous doses of sovateltide on days 1, 3, and 6, alongside standard stroke treatment. Each dose is 0.3 micrograms per kilogram of body weight, given over one minute with about three hours between doses, totaling 0.9 micrograms per kilogram daily on those days. The other group receives an equal volume of normal saline on the same schedule plus standard treatment. Patients are monitored closely during the study period for safety and treatment effects. Participants will be followed for three months with three study visits during this time. Researchers will assess stroke severity and recovery using scales like the NIH Stroke Scale, Modified Rankin Scale, and Barthel Index. Safety is tracked by recording adverse events and lab tests, vital signs, and physical exams. The main outcome is the proportion of patients experiencing adverse events within 90 days. The study also evaluates changes in stroke-related scores, quality of life, risk of stroke recurrence, and mortality.