Indianapolis, IN Paid Clinical Trials

Protocol GVO-1102 is a phase 1, open label, multi-center study in adult patients with locally advanced or metastatic solid tumors. This study includes two parts: dose escalation and dose expansion. In the dose escalation phase, GEN2 will be administered at increasing dose levels via intravenous infusion or intratumoral injection on Days 1, 3 and 8 every 4 weeks. Valganciclovir will start dosing on Day 12 and continue for 10 days (through Day 21). Once a recommended dose has been defined in approximately 35-45 patients, the dose expansion phase will initiate to further assess intravenous administration of GEN2 in specific tumor types. Approximately 15 patients per tumor type will be enrolled in the intravenous dose expansion phase. Read Less

The main objective of this study is to explore the efficacy of avacopan in participants affected by AAV. Read Less

This study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer. Read Less

The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD). Read Less

The goal of this clinical trial is to evaluate the safety and tolerability of the study drug WTX-330 when administered using a fixed dose regimen or a step-up dose regimen in adult patients with selected advanced or metastatic solid tumors or lymphoma. In addition to safety and tolerability, the study aims to: * determine the maximum initial dose of WTX-330 that may be used in the step-up dose regimen * determine whether the step-up dose regimen can increase WTX-330 exposure in patients due to improved tolerability * determine the maximum tolerated dose (MTD) of WTX-330 and/or recommended dose for expansion (RDE) for each regimen * evaluate the antitumor activity of WTX-330 * characterize the pharmacokinetic (PK) profile of WTX-330 * characterize the interferon gamma (IFNγ) profile after treatment with WTX-330 * evaluate changes in immunological biomarkers * determine the impact of WTX-330 on overall survival (OS) Study participants will participate in a dose- and regimen-finding phase (Part 1) followed by a dose expansion phase (Part 2) where they will be assigned to one of three arms (A, B and C). Read Less

Ifetroban prevents and treats lung fibrosis due to multiple causes (bleomycin, genetic, radiation). The safety and efficacy of oral ifetroban will be assessed in patients with IPF. Read Less

This phase I trial tests the safety, side effects, and best dose of ex vivo expanded natural killer cells in treating patients with cancerous (malignant) tumors affecting the upper part of the brain (supratentorial) that have come back (recurrent) or that are growing, spreading, or getting worse (progressive). Natural killer (NK) cells are immune cells that recognize and get rid of abnormal cells in the body, including tumor cells and cells infected by viruses. NK cells have been shown to kill different types of cancer, including brain tumors in laboratory settings. Giving NK cells from unrelated donors who are screened for optimal cell qualities and determined to be safe and healthy may be effective in treating supratentorial malignant brain tumors in children and young adults. Read Less

This multi-center comparative prospective cohort study is designed to assess the real world clinical impact, including safety and test performance, of Galleri®, a blood-based multi-cancer early detection (MCED) test. The study will seek to enroll approximately 20% of the study participants from under-represented minority populations (e.g., racial / ethnic minority groups, socioeconomically disadvantaged populations, rural populations). Read Less

The program involves a virtual intervention to be delivered by RN or SW care coordinators over one year. Every care partner will receive monthly virtual visits during the first 3 months and then quarterly or more depending on assessed need. The intervention relies on a tailored approach in which patient and caregiver needs are identified during visits using validated assessment tools and addressed with standardized protocols. Protocols include management of behavioral/psychological symptoms of dementia, caregiver stress, medication management, comorbidity management and advance care planning. Read Less

Hidradenitis suppurativa (HS) is a chronic and often painful inflammatory skin disease which includes the forming of lumps, abscesses and scars in areas of the skin such as under the breasts, under armpits, inner thighs, groin and buttocks. This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS . Lutikizumab is an investigational drug being developed for the treatment of HS. During Period 1 of the study, participants will placed in 1 of 2 groups called treatment arms. There is a 1 in 2 chance that participants will be assigned to placebo. Around 1280 adult and adolescent participants with moderate to severe HS will be enrolled in the study at approximately 275 sites world wide. During Period 2, participants that were part of the lutikizumab treatment arm in Period 1 will be re-randomized to 1 of 2 lutikizumab treatment arms. Participants that were part of the Placebo arm in Period 1 will start Period 2 with an initiation of lutikizumab followed by a re-randomization to 1 of 2 lutikizumab treatment arms. In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive subcutaneous injections of lutikizumab every week or every other week for 36-weeks. Participants that were randomized to the placebo arm in Period 1 will receive subcutaneous injections of lutikizumab every week for 16 weeks, then either every week or every other week for 20 weeks. Period 3 is the Long Term Extentsion (LTE) and through Week 68, participants will continue to receive lutikizumab SC using the same assigned dosing regimen from the end of Period 2 for 16 weeks followed by open-label lutikizumab EOW for 140 weeks. Participants in the US that complete Periods 1 \& 2 will have the option to enroll in a 156-week open-label Sub-Study that will assess the long term safety and efficacy of lutikizumab in a prefilled pen. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires and diaries. Read Less

The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits. Read Less

The main purpose of the study is to assess whether the study drug, LY4066434, is safe and tolerable when administered to participants with locally advanced or metastatic solid tumors with certain KRAS mutations. LY4066434 will be given alone or in combination with other treatments. The study will have 2 parts: monotherapy dose escalation and dose optimization. The study is expected to last up to approximately 5 years. Read Less