336 recruiting in this snapshot
First-in-human or early safety and dose studies. Small groups. Not designed to prove a treatment works.
On a ClinicalTrials.gov record, Phase 1 (and Early Phase 1) usually means the main questions are safety, dose, and how the body handles the product. Groups are small. Some phase 1 studies enroll people with the disease; others enroll healthy volunteers.
A phase 1 listing is not evidence that the product is effective for you. It is also not an FDA approval. Read eligibility, visit burden, and the consent form with the study team.
PlainTrials applies this label only when the registry Phase field contains PHASE1 or EARLY_PHASE1. We do not reclassify studies.
Asthma is a heterogeneous disorder in which multiple potential inflammatory pathways contribute to airway obstruction. The biological basis for airway inflammation is the subject of intensive investigation.
NCT00595491 · Official ClinicalTrials.gov record · Benjamin Medoff
Background: \- The blood-brain barrier separates the brain from the rest of the body. Epilepsy is a neurological disease that causes seizures.
NCT02531880 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
The specific aims of the study are: Primary: To determine the presence and regional distribution of microglial activation, as assessed by Fluorine-18 (18F) labeled "Peripheral Benzodiazepine Receptor 06" (PBR06) -PET, in subjects with active Relapsing Remitting Multiple Sclerosis (RRMS), Secondary Progressive Multiple Sclerosis (SPMS), and Alzheimer's Disease (AD) as compared to healthy controls Secondary: 1. To assess the relationship between microglial activation and clinical variables including disease severity and comorbidities (such as pain, fatigue and/or depression), as well as clinical MRI findings (such as lesions and atrophy) 2.
NCT02649985 · Official ClinicalTrials.gov record · Brigham and Women's Hospital
Background: Most medications that treat depression take weeks or months to work. Researchers want to develop fast-acting treatments.
NCT03065335 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to find the highest tolerable dose of gemcitabine that can be given by inhalation (breathing it as a mist) to patients with solid tumors that have spread to the lungs from other parts of the body.
NCT03093909 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center
Background: Crohn s disease (CD) is an inflammatory bowel disease. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.
NCT03167437 · Official ClinicalTrials.gov record · National Institute of Allergy and Infectious Diseases (NIAID)
This is an umbrella study evaluating the how well it works and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages.
NCT03424005 · Official ClinicalTrials.gov record · Hoffmann-La Roche
This phase I study is designed to establish the safety, maximally tolerated dose (MTD) and recommended phase II dose (RP2D) of the ERK inhibitor ulixertinib (BVD-523) when combined with the CDK4/6 inhibitor palbociclib.
NCT03454035 · Official ClinicalTrials.gov record · UNC Lineberger Comprehensive Cancer Center
This is a Phase I/II, multicenter, open-label, dose escalation/dose-expansion study to measure the tolerability, safety, and the maximum tolerated dose (MTD) of ruxolitinib when given with fixed dose nivolumab in patients with relapsed or refractory classical Hodgkin lymphoma (cHL).
NCT03681561 · Official ClinicalTrials.gov record · Veronika Bachanova
Some people who have what doctors currently call schizophrenia or bipolar disease may actually have a brain disease caused by auto-antibodies. Auto-antibodies are produced when the normal defense mechanism of the body goes wrong and begins to attack the body, similar to "friendly fire." Auto-antibodies attack brain receptors and then the person who has this problem begins to have hallucinations and other manifestations of schizophrenia, like feeling that people can see what they are thinking and also feeling that other people do not like them.
NCT03971487 · Official ClinicalTrials.gov record · The Methodist Hospital Research Institute
The main purpose of this study is to determine the safety, tolerability (how the body reacts to the drug\[s\]) and effectiveness (ability to treat the cancer) of REGN5678 (Nezastomig) alone, or in combination with cemiplimab. The goal of Part 1 (dose escalation) is to determine a safe dose(s) of REGN5678 when it is given alone or in combination with cemiplimab.
NCT03972657 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals
Background: Most drugs that treat mood disorders take a long time to work. Certain receptors in the brain might help ketamine work.
NCT03973268 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
Background: Sickle cell disease can often be treated with blood stem cell transplants. This study will give a second transplant to people whose disease has returned but still have some donor cells in their body.
NCT04008368 · Official ClinicalTrials.gov record · National Heart, Lung, and Blood Institute (NHLBI)
This pilot study will assess the safety and feasibility of using an implantable microdevice to measure local intratumor response to chemotherapy and other clinically relevant drugs in malignant brain tumors. * The device involved in this study is called a microdevice.
NCT04135807 · Official ClinicalTrials.gov record · Oliver Jonas
This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.
NCT04192344 · Official ClinicalTrials.gov record · Abbisko Therapeutics Co, Ltd
This is a Phase 1/2, open-label, non-randomly assigned, 4-part trial to determine the safety profile and identify the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of INBRX 106 administered as a single agent or in combination with the anti-PD-1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®). KEYTRUDA is a registered trademark of Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA.
NCT04198766 · Official ClinicalTrials.gov record · Inhibrx Biosciences, Inc
Background: Metastasis is the spread of cancer from one organ to a nonadjacent organ. No treatment specifically prevents or reduces metastasis.
NCT04222413 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
Background: Age-related macular degeneration is a common eye disease in people over 50. The "dry" form of the disease can worsen into geographic atrophy, causing blind spots.
NCT04339764 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
Background: About 5 million adults in the U.S. have Alzheimer s disease or another adult-onset neurodegenerative disorder.
NCT04396873 · Official ClinicalTrials.gov record · National Institute of Mental Health (NIMH)
The purpose of this randomly assigned study is to determine the safety and how well it works of quaratusugene ozeplasmid (Reqorsa) added to osimertinib in NSCLC patients with activating EGFR mutations who have progressed while on treatment with osimertinib. Quaratusugene ozeplasmid consists of non-viral lipid nanoparticles that encapsulate a DNA plasmid with the TUSC2 tumor suppressor gene and is the first systemic gene therapy for cancer.
NCT04486833 · Official ClinicalTrials.gov record · Genprex, Inc.
This is a Phase 1b open-label, multicenter study, evaluating the safety, tolerability, preliminary clinical activity, pharmacokinetics (PK), and pharmacodynamics of azenosertib (ZN-c3) in combination with other drugs.
NCT04516447 · Official ClinicalTrials.gov record · K-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
The primary objective will be to demonstrate the manufacturing feasibility and safety, and to determine the maximum tolerated dose (MTD) of RNA-LP vaccines in (Stratum 1) adult patients with newly diagnosed GBM (MGMT low level or unmethylated in adults only) and (Stratum 2) in pediatric patients with newly diagnosed HGG (pHGG).
NCT04573140 · Official ClinicalTrials.gov record · University of Florida
Hepatocellular carcinoma (HCC) is the fifth more common cancer in the world, with high mortality rates, due to the low number of patients who are eligible for therapy with curative intent, like surgical resection. Moreover, surgical resection is associated with a high risk of tumor recurrence, because of the tumor seeding through microscopic intrahepatic vessels that surround the tumor, the so-called "microvascular invasion".
NCT04587739 · Official ClinicalTrials.gov record · University Hospital, Lille
This trial investigates whether hyperpolarized magnetic resonance imaging (hpMRI) can predict treatment response in patients with thyroid cancer and other malignancies of the head and neck undergoing radiation therapy and/or receiving systemic therapy before surgery. An hpMRI is like a standard MRI but involves the use of an imaging contrast agent called hyperpolarized 13-C-pyruvate.
NCT04589624 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of talazoparib when given in combination with palbociclib, axitinib, or crizotinib in treating patients with solid tumors that has spread to nearby tissue or lymph nodes (locally advanced) or other places in the body (metastatic). PARPs are proteins that help repair damaged DNA, the genetic material that serves as the body's instruction book.
NCT04693468 · Official ClinicalTrials.gov record · M.D. Anderson Cancer Center
This is an open label, non-randomly assigned, 2-center, phase 1/2 trial of a single infusion of sickle allele modified cluster of differentiation (CD34+) hematopoietic stem progenitor cells (HSPCs) in subjects with in subjects ≥12 years old to 35 years old severe Sickle Cell Disease (SCD). The study will measure the hematopoietic stem cell transplantation (HSCT) using CRISPR/Cas9 edited red blood cells (known as CRISPR\_SCD001 Drug Product).
NCT04774536 · Official ClinicalTrials.gov record · Mark Walters, MD
This phase Ib trial is to find out the best dose, possible benefits and/or side effects of osimertinib and tegavivint as first-line therapy in treating patients with EGFR-mutant non-small cell lung cancer that has spread to other places in the body (metastatic). Osimertinib and tegavivint may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
NCT04780568 · Official ClinicalTrials.gov record · Ohio State University Comprehensive Cancer Center
This is a Phase Ib/II, open-label, multicenter, randomly assigned umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population.
NCT04802759 · Official ClinicalTrials.gov record · Hoffmann-La Roche
Background: Cytoreductive surgery (CRS) removes tumors in the abdomen. HIPEC is hyperthermic (heated) chemotherapy that washes the inside of the abdomen.
NCT04847063 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This open-label, exploratory study is designed to measure the safety and how well it works of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
NCT04929223 · Official ClinicalTrials.gov record · Hoffmann-La Roche
Background: Certain blood cancers can be treated with blood or bone marrow transplants. Sometimes the donor cells attack the recipient's body, called graft-versus-host disease (GVHD).
NCT04959175 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)
This trial will study the safety and how well it works of intravenous infusion and intra-articular injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Rheumatoid Arthritis
NCT05003934 · Official ClinicalTrials.gov record · The Foundation for Orthopaedics and Regenerative Medicine
This study wants to determine the safety and feasibility of administering the Tetanus Diptheria Vaccine (Td) or Polio Boost Immunization (IPOL) to patients with metastatic melanoma who are receiving immune checkpoint inhibitor (IO) therapy per standard of care. Subjects will have the vaccine at cycle 4 of IO therapy and will have research blood and tissue samples collected prior to starting IO therapy, at cycle 4 prior to vaccine administration, and at 12-17 days post vaccine.
NCT05077137 · Official ClinicalTrials.gov record · Duke University
Recent lab-based discoveries suggest that IDO (indoleamine 2,3-dioxygenase) and BTK (Bruton's tyrosine Kinase) form a closely linked metabolic checkpoint in tumor-associated antigen-presenting cells. The central clinical hypothesis for the GCC2020 study is that combining ibrutinib (BTK-inhibitor) with indoximod (IDO-inhibitor) during chemotherapy will synergistically enhance anti-tumor immune responses, leading to improvement in clinical response with manageable overlapping toxicity.
NCT05106296 · Official ClinicalTrials.gov record · Theodore S. Johnson
This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.
NCT05137054 · Official ClinicalTrials.gov record · Regeneron Pharmaceuticals
This phase I trial studies the safety of giving multiple intracerebral doses of NSC-CRAd-S-pk7 to treat patients with glioblastoma at first recurrence. NSC-CRAd-S-pk7 consists of neural stem cells that can target glioblastoma cells and carry a virus, which can kill cancer cells.
NCT05139056 · Official ClinicalTrials.gov record · City of Hope Medical Center
This trial will study the safety and how well it works of intranasal delivery of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cell exosomes for the treatment of non-arteritic ischemic optic neuropathy
NCT05147701 · Official ClinicalTrials.gov record · The Foundation for Orthopaedics and Regenerative Medicine
This is a study of ATG-037 this drug alone and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
NCT05205109 · Official ClinicalTrials.gov record · Antengene Therapeutics Limited
The FRONTIER Study is a prospective, treatment, single-arm, multi-center, study to assess the safety and technical feasibility of TheraSphere GBM in patients with recurrent GBM.
NCT05303467 · Official ClinicalTrials.gov record · Boston Scientific Corporation
Background: People with blood cancers often receive blood or bone marrow transplants. But even with these treatments, the risk of relapse is high.
NCT05327023 · Official ClinicalTrials.gov record · National Cancer Institute (NCI)