Navi Mumbai

Researchers are studying the effects of AP-Brain collagen peptide on attention, focus, stress, and memory in adults aged 35 to 70 who are stressed but otherwise healthy. The study aims to find out how different doses of AP-Brain affect brain function and to identify any side effects. The trial is a randomized, open-label, parallel design sponsored by Rousselot BVBA. Participants will take either a low dose one 1g tablet or a higher dose three 1g tablets of bovine-based AP-Brain collagen peptide once daily for 56 days. The study includes two groups receiving these different doses to compare their effects on cognitive abilities and stress levels. During the study, participants will visit the study center regularly for checkups. They will complete tests that measure attention, focus, and memory and answer surveys about stress. Blood samples will be collected, vital signs checked, and brain responses monitored to understand the impact of AP-Brain. The main outcome focuses on changes in attention and focus after 56 days of treatment.

Researchers are conducting a Phase I open-label study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose of AUR107 in adults with relapsed advanced malignancies. The study focuses on patients with selected advanced solid tumors, such as non-small cell lung cancer, gastric cancer, urothelial cancer, kidney cancer, colon cancer, and esophageal cancer, who have no curative or life-prolonging treatment options left. This first-in-human trial aims to find the best dose of AUR107 using a traditional dose-escalation design. Participants will receive oral AUR107 once daily at escalating doses ranging from 5 mg to 200 mg. The trial follows a 33 dose escalation design to evaluate safety and determine the optimal biological dose based on safety, pharmacokinetics, and pharmacodynamics data. The study is multicenter and includes dose expansion following dose escalation. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-related adverse events over 28-day cycles. Researchers will measure pharmacokinetic parameters such as maximum concentration, time to maximum concentration, area under the curve, mean residence time, and elimination half-life at various time points under fasting and fed conditions. Safety assessments and clinical evaluations will be conducted throughout the study, which is expected to continue until June 2027.

Researchers are evaluating the effectiveness and safety of brenipatide combined with standard care compared to a placebo plus standard care for treating schizophrenia in adults aged 18 to 55. This phase 2 clinical trial aims to better understand how brenipatide works alongside existing treatments in this population. Participants are randomly assigned to receive either brenipatide or placebo, both administered by subcutaneous injection, alongside their usual standard of care medications. The study includes a screening period lasting about one month, followed by a treatment period that can last up to 12 months, and then a follow-up period of approximately two months. During the trial, participants will attend scheduled visits to monitor their health, complete questionnaires, and maintain diaries about their medication use. Researchers will measure changes in body weight, neurocognitive function, schizophrenia symptom severity, and other clinical assessments. Safety is closely monitored throughout, and the total participation time may last up to about 15 months.

Researchers are evaluating the safety and effectiveness of brentuximab vedotin combined with doxorubicin, vinblastine, and dacarbazine AVD in adults with untreated stage 3 or 4 classical Hodgkin Lymphoma. This phase 4 study focuses on how well this combination works and monitors any side effects experienced by participants. The study is open-label and involves patients from India with confirmed Hodgkin Lymphoma. Participants will receive brentuximab vedotin at a dose of 1.2 mgkg through intravenous infusion on days 1 and 15 of each 28-day treatment cycle. Each infusion is given within one hour after receiving doxorubicin, vinblastine, and dacarbazine infusions. This treatment is provided for up to six cycles, lasting about six months in total. During the study, participants will have heart function tested by echocardiography and lung function assessed by pulmonary function tests. Researchers will review safety by tracking adverse events for up to 40 weeks and assess how well the treatment works by measuring remission rates and survival outcomes. After finishing treatment, participants will have a final health check two months later to monitor their status and overall well-being.

Researchers are evaluating if adding LY3537982 olomorasib to standard anti-cancer drugs improves treatment for participants with untreated advanced non-small cell lung cancer NSCLC that has a specific KRAS G12C gene change. This Phase 3 treatment study includes participants with locally advanced or metastatic NSCLC and aims to compare this combination against standard care. The study is sponsored by Eli Lilly and Company and could last up to 3 years depending on individual response and disease progression. Participants receive LY3537982 orally combined with pembrolizumab given intravenously in 21-day cycles. Some groups also receive chemotherapy drugs pemetrexed and platinum cisplatin or carboplatin intravenously. There are different dose levels and combinations being tested, including placebo groups for comparison. Treatment continues until specific discontinuation criteria are met. Parts of the study are randomized and double-blinded, with some parts non-randomized for safety lead-in. During the study, participants have regular assessments including imaging scans to measure tumor response, blood tests, and questionnaires about symptoms and quality of life. Researchers monitor side effects and survival outcomes. The main measures include progression-free survival and treatment-emergent adverse events over about one year, with overall survival followed for up to three years. Participants are closely followed throughout treatment and after to evaluate the effects and safety of the study medications.

Researchers are evaluating BMS-986365 compared to the investigators choice of therapy in men with Metastatic Castration-resistant Prostate Cancer. This phase 3, randomized trial aims to assess how well BMS-986365 works and how safe it is, focusing on radiographic progression-free survival. The study includes participants who have previously been treated with androgen receptor pathway inhibitors and have metastatic prostate cancer confirmed by imaging. Participants are randomized into groups receiving either one of two dose levels of BMS-986365 or an active comparator treatment chosen by the investigator, which includes either Docetaxel plus PrednisonePrednisolone or Enzalutamide or Abiraterone plus PrednisonePrednisolone. The study has two parts Part 1 compares the different doses and comparator arms, while Part 2 focuses on the selected BMS-986365 dose versus the investigators choice. Dosing schedules are specified but not detailed here. During the study, participants undergo regular assessments including imaging scans to evaluate cancer progression, pain and symptom questionnaires, blood tests, electrocardiograms, and monitoring for adverse events. Outcomes measured include progression-free survival, overall survival, response rates, pain progression, and quality of life changes. The study may last up to 4 years, with ongoing safety and efficacy evaluations throughout this time.

Researchers are evaluating the effectiveness and safety of combining Dato-DXd with rilvegostomig as an additional treatment compared to standard care in adults with high-risk muscle invasive urothelial carcinoma MIUC who have undergone radical surgery. This Phase III trial focuses on participants with residual disease at high risk of recurrence after surgery. The study aims to see if the new combination improves disease-free survival compared to current standard treatments. Participants are randomly assigned to one of three groups Arm 1 receives Dato-DXd plus rilvegostomig intravenously every three weeks for up to one year Arm 2 receives Dato-DXd alone on the same schedule Arm 3 receives standard care, which includes nivolumab, durvalumab, or a combination of enfortumab vedotin and pembrolizumab, given intravenously at intervals ranging from every two to four weeks for up to a year. Treatment duration and dosing can be adjusted based on tolerance and investigator assessment. During the trial, participants will have visits approximately every three weeks or as per standard care schedules, depending on their assigned group, for up to 12 months of treatment. Researchers will monitor disease recurrence and survival outcomes for up to 78 months from the first participants enrollment. Assessments include clinical evaluations and disease status monitoring to measure disease-free survival and overall survival. Participants will be followed closely to assess safety and effectiveness of the treatments over this extended period.

This research aims to evaluate the superiority of AZD2265 compared to standard care treatments in adult men with PSMA-positive metastatic castration-resistant prostate cancer mCRPC. The study focuses on measuring radiographic progression-free survival and overall survival to understand how well AZD2265 performs against existing therapies. Approximately 670 participants will be involved in this phase III randomized controlled trial sponsored by AstraZeneca. Participants will be randomly assigned to receive either AZD2265 or one of the standard care treatments chosen by the investigator, which may include cabazitaxel chemotherapy, switching androgen receptor pathway inhibitors ARPIs, or radium-223 therapy. Treatment continues until disease progression, unacceptable side effects, or other reasons for stopping. Tumor scans will be conducted during and after treatment to monitor disease status. Throughout the study, participants will undergo tumor evaluation scans regularly to detect progression or response. They will be followed for survival until the study ends in 2029. Safety and scientific integrity will be overseen by an independent committee. Researchers will assess various outcomes, including progression-free survival, PSA reductions, response rates, and bone event-free survival, with plasma levels of AZD2265 monitored during early treatment cycles.

Researchers are evaluating oral sodium copper chlorophyllin CHL in patients aged 12 to 65 years who are undergoing myeloablative total body irradiation TBI as part of conditioning before their first allogeneic hematopoietic stem cell transplantation HSCT. This Phase II, single-arm study aims to assess whether CHL can reduce the frequency and severity of oral mucositis, a common and painful complication of TBI that affects eating, increases pain medication use, and can lead to longer hospital stays and infections. Participants will receive 750 mg of oral sodium copper chlorophyllin once daily, either as a tablet or oral suspension, starting 48 hours before beginning TBI conditioning and continuing until 28 days after the transplant. Alongside this, they will undergo standard TBI-based conditioning and allogeneic HSCT as part of their routine medical care. The study focuses on the safety and effectiveness of CHL in reducing severe oral mucositis and related treatment toxicities. During the study, participants will have regular clinical assessments to monitor oral mucositis severity, treatment-related side effects, engraftment progress, and graft-versus-host disease. Blood and saliva samples will be collected at set times for analysis of inflammatory markers and drug levels. The primary measure is the occurrence of severe oral mucositis by 28 days post-transplant, with additional outcomes including duration of mucositis, use of nutrition and pain medications, and transplant complications. The total study period extends through 100 days post-transplant for some assessments.

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone Genotropin for treating children born Small for Gestational Age SGA or with Idiopathic Short Stature ISS. This randomized, open-label study involves pre-pubertal children who have not previously received growth hormone treatment. The study is planned to last 12 months, including a screening period of up to 30 days, and aims to measure growth outcomes in these children. The study includes two groups one with 140 children with SGA and another with 114 children with ISS. Both groups will be randomly assigned to receive either Somatrogon once weekly via a subcutaneous disposable prefilled pen or Genotropin daily subcutaneous injections using commercial growth hormone delivery devices. Treatment will continue for 12 months for all participants. Participants will be involved in regular visits to assess growth through measurements such as annual height velocity, height standard deviation scores, bone maturation, and levels of Insulin-like Growth Factor-1 IGF-1. Quality of life related to health will also be evaluated before and after treatment. Monitoring includes laboratory tests and maintaining stable hormone levels. The total participation duration includes the screening and 12 months of treatment, with assessments at multiple time points throughout the study.