Visakhapatnam

Researchers are investigating new treatments for metastatic cervical cancer, which is cancer that has spread beyond the cervix, the lower part of the uterus. This study evaluates the safety and effectiveness of the antibody drug conjugate sacituzumab tirumotecan sac-TMT combined with pembrolizumab and bevacizumab. The goal is to find out if these treatments, given together or with some variations, help patients live longer or delay cancer progression compared to standard care. The study has two parts. In Part 1, participants receive sac-TMT, pembrolizumab, and bevacizumab together to assess safety. In Part 2, all participants first get standard induction treatment with pembrolizumab, paclitaxel, and cisplatin or carboplatin, possibly with bevacizumab. Those whose cancer does not worsen then enter maintenance treatment, where they are randomly assigned to receive either pembrolizumab alone or sac-TMT plus pembrolizumab, with optional bevacizumab. Participants are involved for up to about 20 months during maintenance treatment after up to 4 months of induction. The study monitors safety by tracking side effects and treatment discontinuations. Effectiveness is measured by progression-free survival and overall survival up to several years. Quality of life and physical functioning are also assessed through questionnaires. Treatments and evaluations occur through regular intravenous infusions and periodic monitoring visits.

Researchers are evaluating the safety and immune response of the RSVpreF vaccine in adults living in India. This phase 3, multicenter, double-blinded, placebo-controlled study aims to learn how the vaccine affects adults, including those with certain stable chronic medical conditions that may increase their risk of respiratory syncytial virus RSV disease. The study is sponsored by Pfizer and focuses on prevention of RSV infection. Participants will be randomly assigned to receive either the RSVpreF vaccine or a placebo. The vaccine is given as an injection, and the study will monitor participants for local and systemic reactions within 7 days after vaccination, as well as adverse events through 1 month and serious adverse events for 3 months post-vaccination. The immune response will be measured by neutralizing antibody levels against RSV A and RSV B before vaccination and 1 month afterward. During the study, participants will be observed for safety and immune response through scheduled visits. Researchers will collect data on side effects, serious health events, and antibody levels. The study includes adults aged 18 and older who live independently and are ambulatory. Participation involves medical history review and physical exams as needed. The trial will continue until January 25, 2027, with assessments focused on vaccine safety and immune response over several months.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan Dato-DXd with or without Durvalumab compared to investigators choice chemotherapy combined with Pembrolizumab in patients with PD-L1 positive locally recurrent inoperable or metastatic triple-negative breast cancer TNBC. This Phase III, randomized, open-label, international study aims to determine if Dato-DXd with Durvalumab can improve progression-free survival and overall survival while assessing quality of life impacts in this patient population. Participants are assigned to one of three groups Dato-DXd with Durvalumab, investigators choice chemotherapy paclitaxel, nab-paclitaxel, or gemcitabine plus carboplatin combined with Pembrolizumab, or Dato-DXd alone. All study drugs are given by intravenous infusion. The study includes stratification by geographic region, disease-free interval, and prior PD-1PD-L1 treatment. Treatment continues with monitoring up to about 33 months for progression-free survival and safety, with some outcomes followed up to 64 months. Throughout the study, participants undergo assessments including imaging to measure tumor response using RECIST criteria, laboratory tests, and questionnaires to evaluate symptoms and quality of life. Researchers monitor time to disease progression, overall survival, response duration, and safety outcomes. Follow-up includes evaluation of subsequent therapies and pharmacokinetics. The total participation duration can be up to several years to capture long-term outcomes.

Researchers are evaluating the effects of Nuvastatic 300 capsule on reducing fatigue related to cancer treatment in adults with metastatic colon cancer who are undergoing first-line chemotherapy. The main goals are to determine if Nuvastatic 300 capsule can significantly reduce cancer-related fatigue compared to a placebo and to assess its safety and tolerability in this patient group. This is a phase III randomized, double-blind, placebo-controlled study sponsored by Natureceuticals Sdn Bhd. Participants will receive either Nuvastatic 300 capsules or placebo capsules, taken three times daily for six cycles lasting about 20 days each, totaling approximately 120 treatment days. All participants will continue their standard chemotherapy during the trial. Blood samples will be collected at screening and at the end of treatment to monitor health and treatment effects. During the study, participants will complete diaries and fatigue assessments according to the protocol. Researchers will measure reduction in cancer-related fatigue from screening to the end of treatment, as well as overall quality of life and functional improvements. The trial includes safety monitoring and will last about six months from screening through treatment completion.

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 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 combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

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 the safety and effectiveness of tirzepatide in adult participants in India who either have type 2 diabetes or are obese or overweight without type 2 diabetes. This phase 4, open-label study aims to understand how tirzepatide works in these groups over approximately 46 weeks. Participants will receive tirzepatide administered by subcutaneous injection. The study includes one treatment arm where all participants receive this medication. Research will focus on tracking serious adverse events related to the drug, as well as changes in body weight, blood sugar control HbA1c, and waist size over the study period. During the 46 weeks of participation, individuals will have regular visits for safety monitoring and assessments. Researchers will measure serious side effects, body weight reduction, HbA1c levels for those with diabetes, and waist circumference changes. This detailed monitoring helps evaluate the drugs impact and gather safety data throughout the treatment period.