Clinical trials: Phase 1
Advanced Solid Tumor
Study of Lunresertib Alone or in Combination With RP-3500 or Zedoresertib (Debio 0123) in Patients With Advanced Solid Tumors
The primary purpose of this study is to assess the safety and tolerability of lunresertib alone and in combination with RP-3500 or in combination with zedoresertib in patients with eligible advanced solid tumors, determine the…
- Trial name
- MYTHIC (NCT04855656)
- Testing
- Lunresertib, RP-3500, Zedoresertib
- Where
- 26 sites in United States, Canada and 3 more
- Volunteers
- 464 people
- Sponsor
- Debiopharm International SA
Malignant Glioma
A Study of the Drug Selinexor With Radiation Therapy in Patients With Newly-Diagnosed Diffuse Intrinsic Pontine (DIPG) Glioma and High-Grade Glioma (HGG)
This phase I/II trial tests the safety, side effects, and best dose of selinexor given in combination with standard radiation therapy in treating children and young adults with newly diagnosed diffuse intrinsic pontine glioma…
- Trial name
- NCT05099003
- Testing
- Biopsy Procedure, Magnetic Resonance Imaging, Radiation Therapy
- Where
- 129 sites in United States, Australia and 2 more
- Volunteers
- 132 people
- Sponsor
- National Cancer Institute (NCI)
Duchenne Muscular Dystrophy
A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Males With Duchenne Muscular Dystrophy (DMD)
The primary objective of this study is to evaluate the safety and tolerability of a single dose of INS1201 via IT administration in ambulatory male participants with DMD.
- Trial name
- ASCEND (NCT06817382)
- Testing
- INS1201
- Where
- 10 sites in United States
- Volunteers
- 12 people
- Sponsor
- Insmed Gene Therapy LLC
Healthy
A Study to Evaluate Safety, Tolerability, and Immunogenicity of V350A and V350B in Healthy Participants (V350-001).
Epstein Barr virus (EBV) is a virus which can cause infectious mononucleosis and is associated with certain kinds of cancer and multiple sclerosis.
- Trial name
- NCT06655324
- Testing
- V350A, V350B
- Where
- 9 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
WHIM, Warts
Base-Edited Hematopoietic Stem/Progenitor Cell Gene Therapy for Treatment of CXCR4-WHIM
Background: Warts, hypogammaglobulinemia, infections and myelokathexis syndrome (WHIMs) is a rare disorder that affects the immune system. People with WHIMs can have severe infections all over their body.
- Conditions
- WHIM, Warts, Hypogammaglobulinemia, Immunodeficiency
- Trial name
- NCT07775313
- Testing
- Busulfan, Palifermin, Plerixafor
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Neuroblastoma (NBL), Ewing Sarcoma
GD2IL18CART Combined With Bevacizumab for Relapsed and Refractory GD2-positive Solid Tumors
This study will test a CAR T-cell treatment combined with bevacizumab in children and young adults with relapsed or refractory neuroblastoma, Ewing sarcoma, or osteosarcoma.
- Conditions
- Neuroblastoma (NBL), Ewing Sarcoma, Osteosarcoma
- Trial name
- GD2CART-BEV (NCT07897968)
- Testing
- Chimeric Antigen Receptor (CAR) Therapy Infusion, Bevacizumab (Avastin)
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Universität Münster
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia
Alpha/Beta CD19+ Depleted Haploidentical Transplantation + Zometa for Pediatric Hematologic Malignancies and Solid Tumors
This phase I trial studies the safety of transplantation with a haploidentical donor peripheral blood stem cell graft depleted of TCRαβ+ cells and CD19+ cells in conjunction with the immunomodulating drug, Zoledronate, given in…
- Conditions
- Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Hodgkin Lymphoma, Non-Hodgkin Lymphoma
- Trial name
- NCT02508038
- Testing
- TCRαβ+/CD19+ depleted Haploidentical HSCT, Zoledronate
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- University of Wisconsin, Madison
Neurofibromatosis 1, Neurofibromatosis Type 1
AZD6244 Hydrogen Sulfate for Children With Nervous System Tumors
Background: Plexiform neurofibromas are tumors that grow in and around nerves. The only way to treat them is with surgery. Some of these tumors cannot be completely removed.
- Conditions
- Neurofibromatosis 1, Neurofibromatosis Type 1, NF1, Neurofibroma, Plexiform
- Trial name
- NCT01362803
- Testing
- AZD6244
- Where
- 4 sites in United States
- Volunteers
- 99 people
- Sponsor
- National Cancer Institute (NCI)
X-linked Severe Combined Immunodeficiency (XSCID)
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
This Phase I/II clinical trial will study the safety and potential benefits of gene therapy for up to 35 people aged 2 to 50 with X-linked severe combined immunodeficiency (XSCID), a rare genetic condition that makes it difficult…
- Trial name
- NCT01306019
- Testing
- Campath, Palifermin, Busulfan
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Somatostatin Receptor Positive, NETs
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following…
- Conditions
- Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor
- Trial name
- KinLET (NCT06441331)
- Testing
- Lutetium Lu 177-Edotreotide, Amino Acid Solution
- Where
- 9 sites in United States, France and 1 more
- Volunteers
- 20 people
- Sponsor
- ITM Solucin GmbH
Aspartylglucosaminuria, Aspartylglucosamidase (AGA) Deficiency
Safety and Efficacy of scAAV9/AGA Gene Therapy in Participants With Aspartylglucosaminuria (AGU)
The goal of this clinical trial is to learn if the treatment is a safe, tolerable, and efficacious treatment for adults and children with Aspartylglucosaminuria (AGU).
- Trial name
- NCT07530796
- Testing
- scAAV9/AGA
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Rare Trait Hope
Advanced Solid Tumors, Ewing Sarcoma
A Phase 1/1B Study of ST-01156, a Small Molecule RBM39 Degrader, in Patients With Advanced Solid Malignancies
A Phase 1/1B Study of ST-01156 in Patients with Advanced Solid Malignancies
- Conditions
- Advanced Solid Tumors, Ewing Sarcoma, Hepatocellular Carcinoma (HCC), Biliary Tract Cancer (BTC)
- Trial name
- NCT07197554
- Testing
- ST-01156
- Where
- 6 sites in United States
- Volunteers
- 171 people
- Sponsor
- SEED Therapeutics, Inc.
Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD)
Microbiota Modulation for Psychiatry Patients
The investigators aim to confirm pilot study findings (REB 119638) on the effects of delayed release apple cider vinegar (drACV).
- Conditions
- Depression - Major Depressive Disorder, Generalized Anxiety Disorder (GAD), Anxiety
- Trial name
- ACV-MTPIES-002 (NCT07899424)
- Testing
- Dietary Supplement: Acetate (Apple Cider Vinegar)
- Volunteers
- 62 people
- Sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Glioblastoma (GBM), Diffuse Midline Glioma (DMG)
Intrathecal Azacitidine and Nivolumab in Patients With Recurrent High-grade Glioma
This is a single-arm open-label phase 1 dose escalation/expansion trial assessing the safety and efficacy of concurrent intrathecal azacitidine and intrathecal nivolumab in recurrent high-grade glioma.
- Conditions
- Glioblastoma (GBM), Diffuse Midline Glioma (DMG), Astrocytoma, IDH-Mutant, Grade 4, Diffuse Hemispheric Glioma, H3 G34-Mutant
- Trial name
- NCT06896110
- Testing
- Nivolumab, Azacitidine (AZA), lumbar puncture
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Andrew P. Groves
Catecholaminergic Polymorphic Ventricular Tachycardia
A Study of SGT-501 Gene Therapy in Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT)
This is a Phase 1b, Multicenter, Open-Label, Dose Finding Study to Investigate the Safety and Tolerability of a Single Intravenous Dose of SGT-501 in participants with catecholaminergic polymorphic ventricular tachycardia (CPVT).
- Trial name
- ARTEMIS (NCT07148089)
- Testing
- SGT-501
- Where
- 5 sites in United States, Canada
- Volunteers
- 18 people
- Sponsor
- Solid Biosciences Inc.
Nicotine Vaping, Nicotine Use Disorder
Testing the Feasibility and Acceptability of Social Media and Digital Therapeutics to Decrease Vaping Behaviors
Use of vaping products (e.g., electronic nicotine delivery systems, e-cigarettes) has been increasing rapidly, particularly among teens and young adults.
- Trial name
- NCT05994209
- Testing
- quitSTART Mobile Application, Chatbot Feature in quitSTART Mobile Application
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- Washington University School of Medicine
B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma
Gene Therapy for CD19-Positive Hematologic Malignancies (SENTRY-CD19)
This is a Phase 1/2, first-in-human, open-label, dose-escalating trial designed to assess the safety and efficacy of VNX-101 in patients with relapsed or refractory CD19-positive hematologic malignancies.
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Large B-cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
- Trial name
- NCT06533579
- Testing
- Dose Level 1, VNX-101, Dose Level 2, VNX-101, Dose Level 3, VNX-101
- Where
- 11 sites in United States
- Volunteers
- 32 people
- Sponsor
- Vironexis Biotherapeutics Inc.
Primary Extra-cranial Solid Tumor, Recurrent or Refractory Glypican 3 (GPC3)
A Study of Codrituzumab in Children and Young Adults With Solid Tumors and Have Not Responded to Treatment or Have Come Back After Treatment
The purpose of this study to find out whether codrituzumab is a safe treatment that causes few or mild side effects in children and young adults who have solid tumors that express the protein GPC3.
- Trial name
- NCT04928677
- Testing
- Codrituzumab
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
A Study of Sonrotoclax (BGB-11417) in Children With Relapsed or Refractory Acute Myeloid Leukemia and B-cell Acute Lymphoblastic Leukemia
The goal of this clinical trial is to learn if sonrotoclax (BGB-11417) is safe and may help treat children and adolescents with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) that has come back after treatment…
- Conditions
- Relapsed Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, B-cell Acute Lymphoblastic Leukemia, Pediatric Cancer
- Trial name
- NCT07770698
- Testing
- sonrotoclax, Azacitidine, Inotuzumab ozogamicin
- Volunteers
- 30 people
- Sponsor
- BeOne Medicines
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