Health Research
and Clinical Studies

All IN for Health provides a list of hundreds of active health studies happening right here in Indiana. These health studies are conducted by faculty at Indiana University, Purdue University, and the University of Notre Dame.

All IN for Health provides a list of hundreds of active health studies happening right here in Indiana. These health studies are conducted by faculty at Indiana University, Purdue University, and the University of Notre Dame.

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Recently added/updated trials

A Phase 1b/2 Multisite Dose- and Regimen-finding and Expansion Study of WTX-330 in Adult Patients with Selected Advanced or Metastatic Solid Tumors or Non-Hodgkin Lymphoma

R
Rohan Maniar
18 years - 100 years
All genders
Phase 1/2
The primary objectives of the dose- and regimen-finding part of this study are the following: To evaluate the safety and tolerability of WTX-330 administered using a fixed dose regimen or a step-up dose regimen To determine the maximum initial dose of WTX-330 that may be used in the step-up dose regimen To determine whether the step-up dose regimen can increase WTX-330 exposure in patients due to improved tolerability To determine the maximum tolerated dose (MTD) of WTX-330 and/or recommended dose for expansion (RDE) for each regimenThe primary objectives of the dose expansion part of this study are the following: To further characterize the safety and tolerability of WTX-330 To evaluate the antitumor activity of WTX-330 as measured by overall response rate (ORR; complete response [CR] + partial response [PR]) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, immune ORR (immune-ORR [iORR]; immune CR [iCR] + immune PR [iPR]) by immune RECIST (iRECIST), or Lugano classification (Cheson et al., 2014) for non-Hodgkin lymphoma (NHL)The secondary objectives of WTX-330x2102 (both parts of study) are the following: To characterize the PK profile of WTX-330 (i.e., both parent compound and free IL-12) To characterize the IFNγ profile after treatment with WTX-330 To evaluate changes in immunological biomarkers in blood samples and tumor biopsies at baseline and after administration of WTX-330 To evaluate the antitumor activity of WTX-330 as measured by duration of response (DOR) and progression-free survival (PFS) by RECIST 1.1, iRECIST, or Lugano classification (Cheson et al., 2014) for NHL. To evaluate the immunogenicity of WTX-330 (i.e., the potential to generate an antidrug antibody [ADA] responseThe secondary objectives of WTX-330x2102 (dose expansion only) are the following: To determine the impact of WTX-330 on overall survival (OS)Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:IU Clinical Trials Office Email: iutrials@iu.edu Phone: (317) 278-5632

A Pivotal Study of Voro Urologic Scaffold for the Treatment of PostProstatectomy Stress Urinary Incontinence

M
Michael Koch, MD
45 years - 100 years
Male
The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.  Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:IU Clinical Trials Office Email: iutrials@iu.edu Phone: (317) 278-5632

Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P-CD19CD20-ALLO1 in Subjects with Selected Relapsed/Refractory B cell Malignancies

H
Huda Salman
18 years - 100 years
All genders
Phase 1
Phase 1 study comprised of open-label, dose escalation and expansion cohort study of P-CD19CD20-ALLO1 allogeneic T stem cell memory (Tscm) CAR-T cells in subjects with relapsed/refractory B cell malignancies.Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:IU Clinical Trials Office Email: iutrials@iu.edu Phone: (317) 278-5632

A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Lumateperone in the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients 5 to 17 Years of Age

L
Leslie Hulvershorn, MD, MSc
13 years - 17 years
All genders
Interventional
This is a multicenter study in pediatric patients aged 13 to 17 years with a primary diagnosis of Autism Spectrum Disorder associated with irritability to evaluate the efficacy of high and low doses of lumateperone compared to placebo for the treatment of irritability associated with Autism Spectrum Disorder and to determine the safety and tolerability of high and low doses of lumateperone compared to placebo.THIS STUDY IS ENROLLING BY INVITATION ONLY

A Phase 1 Study of GEN2 in Adult Patients with Locally Advanced or Metastatic Solid Tumor Malignancies

K
Kathy Miller, MD
18 years - 100 years
All genders
Phase 1
Protocol GVO-1102 is a phase 1, open label, multi-center study in adult patients with locally advanced or metastatic solid tumors. GEN2 is a non-replicating off-the-shelf gene therapy vector product being developed as a cancer immunotherapy to activate a patient's immune system against their personal cancer antigens (neoantigens). The vector payload encodes for a suicide gene, an enhanced viral thymidine kinase enzyme (HSV-eTK), which in the presence of a prodrug, valganciclovir, causes the tumor to release patient specific tumor antigens. These neoantigens in the presence of a human immune modulator cytokine, granulocyte-macrophage colony-stimulating factor (hGM-CSF), results in the generation of immune effector cells. These effector cells maintain continually amplifying therapeutic immune responses as more tumor cells are killed and release antigen and will potentially kill any new tumor metastases that arise.Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:IU Clinical Trials Office Email: iutrials@iu.edu Phone: (317) 278-5632

An Interventional Efficacy and Safety Phase 3 Double-blind 2-arm Study to Investigate IV Followed by Oral Fosmanogepix Compared With IV Caspofungin Followed by Oral Fluconazole in Adult Participants With Candidemia and/or Invasive Candidiasis

N
Nicolas Barros, MD
18 years - 100 years
All genders
Phase 3
Interventional
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Fosmanogepix) for the potential treatment of candidemia and/or invasive candidiasis, a life-threatening fungal infection caused by several species of yeast called Candida.The study is seeking patients who have a diagnosis of candidemia and/or invasive candidiasis.THIS STUDY IS ENROLLING BY INVITATION ONLY

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone in the Treatment of Pediatric Patients With Schizophrenia or Bipolar Disorder

L
Leslie Hulvershorn, MD, MSc
10 years - 17 years
All genders
Phase 3
Interventional
This study investigates the safety and tolerability of an investigational medication in young people with schizophrenia or bipolar disorder. Schizophrenia is a mental disorder that affects how a person thinks, feels, and behaves. Bipolar disorder is a condition that causes extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). THIS STUDY IS ENROLLING BY INVITATION ONLY - This study is enrolling patients with schizophrenia, including patients who have previously participated in the lumateperone open-label pediatric pharmacokinetic (PK) study (Study ITI-007-020), Patients with bipolar disorder who have previously participated in the lumateperone open-label pediatric PK study (Study ITI-007-030), and patients with bipolar disorder who are enrolling directly from a lead-in efficacy study.