Search Clinical Trials
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Tusamitamab Ravtansine Monotherapy and in Combination in Patients With CEACAM5-positive Advanced Solid...
Sanofi
Breast Cancer Metastatic
Pancreatic Carcinoma Metastatic
Primary Objective:
- For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of
tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine
monotherapy and in combination with gemcitabine in metastatic pancreatic... expand
Primary Objective: - For Cohort A, Cohort B, and Cohort C Part 2: To assess the antitumor activity of tusamitamab ravtansine in metastatic breast cancer (mBC) and tusamitamab ravtansine monotherapy and in combination with gemcitabine in metastatic pancreatic adenocarcinoma (mPAC) - For Cohort C Part 1: Confirmation of the recommended tusamitamab ravtansine dose when administered in combination with gemcitabine Secondary Objectives: - To assess the safety and tolerability of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess other efficacy parameters of tusamitamab ravtansine administered as monotherapy and in combination with gemcitabine - To assess the immunogenicity of tusamitamab ravtansine - To assess the pharmacokinetics (PK) of tusamitamab ravtansine and gemcitabine when given in combination Type: Interventional Start Date: Mar 2021 |
Clinical and Genetic Evaluation of Individuals With Undiagnosed Disorders Through the Undiagnosed Diseases...
National Human Genome Research Institute (NHGRI)
Genetic Disease
Without an explanation for severe and sometimes life-threatening symptoms, patients and their
families are left in a state of unknown. Many individuals find themselves being passed from
physician to physician, undergoing countless and often repetitive tests in the hopes of... expand
Without an explanation for severe and sometimes life-threatening symptoms, patients and their families are left in a state of unknown. Many individuals find themselves being passed from physician to physician, undergoing countless and often repetitive tests in the hopes of finding answers and insight about what the future may hold. This long and arduous journey to find a diagnosis does not end for many patients- the Office of Rare Diseases Research (ORDR) notes that 6% of individuals seeking their assistance have an undiagnosed disorder. In 2008, the National Institutes of Health (NIH) Undiagnosed Diseases Program (UDP) was established with the goal of providing care and answers for these individuals with mysterious conditions who have long eluded diagnosis. The NIH UDP is a joint venture of the NIH ORDR, the National Human Genome Research Institute Intramural Research Program (NHGRI-IRP), and the NIH Clinical Research Center (CRC) (1-3). The goals of the NIH UDP are to: (1) provide answers for patients with undiagnosed diseases; (2) generate new knowledge about disease mechanisms; (3) assess the application of new approaches to phenotyping and the use of genomic technologies; and (4) identify potential therapeutic targets, if possible. To date, the UDP has evaluated 3300 medical records and admitted 750 individuals with rare and undiagnosed conditions to the NIH Clinical Center. The NIH UDP has identified more than 70 rare disease diagnoses and several new conditions. The success of the NIH UDP prompted the NIH Common Fund to support the establishment of a network of medical research centers, the Undiagnosed Diseases Network (UDN), for fiscal years 2013-2020. The clinical sites will perform extensive phenotyping, genetic analyses, and functional studies of potential disease-causing variants. The testing performed on patients involves medically indicated studies intended to help reach a diagnosis, as well as research investigations that include a skin biopsy, blood draws, and DNA analysis. In addition, the UDN will further the goals of the UDP by permitting the sharing of personally identifiable phenotypic and genotypic information within the network. By sharing participant information and encouraging collaboration, the UDN hopes to improve the understanding of rare conditions and advance the diagnostic process and care for individuals with undiagnosed diseases. Type: Observational Start Date: Sep 2015 |
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia...
Sanofi
Hemophilia A
This is a prospective, observational, multi-center longitudinal cohort study to describe the
real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with
hemophilia A treated per standard of care in the US and Japan.
Patients will be enrolled... expand
This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in the US and Japan. Patients will be enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape in each study country. Decision to initiate treatment with commercially available efanesoctocog alfa will be made by the treating physician independently from the decision to include patients in the study. No study medication is provided. The data related to efanesoctocog alfa effectiveness, safety and usage will be collected prospectively during routine visits (expected annual/semi-annual visits) for up to 5 years following enrollment /treatment initiation. Type: Observational Start Date: Jun 2023 |
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Massachusetts General Hospital
Liver Disease Chronic
End Stage Liver DIsease
Cirrhosis
Cirrhosis, Liver
Advanced Cirrhosis
The goal of this clinical trial is to evaluate whether early integration of palliative care
in the care of hospitalized patients with advanced liver disease (AdvLD) can improve
patients' quality of life, physical symptoms, mood, and serious illness communication.
Palliative... expand
The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness. Type: Interventional Start Date: Sep 2023 |
Assessment of Combined CCM and ICD Device in HFrEF
Impulse Dynamics
Heart Failure
Heart Failure With Reduced Ejection Fraction
Implantable Defibrillator User
CCM Therapy
Non-ischemic Cardiomyopathy
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System
(the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF)
and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in... expand
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years. Type: Interventional Start Date: May 2023 |
A Safety, Tolerability and Efficacy Study of NC525 in Subjects With Advanced Myeloid Neoplasms
NextCure, Inc.
Relapsed or Refractory Acute Myeloid Leukemia
Relapsed or Refractory Chronic Myelomonocytic Leukemia
Relapsed or Refractory Myelodysplastic Syndrome
This is an open-label, non-randomized, Phase 1 study to determine the safety and tolerability
of NC525. This study will also assess the clinical benefit in subjects with advanced myeloid
neoplasms.
expand
This is an open-label, non-randomized, Phase 1 study to determine the safety and tolerability of NC525. This study will also assess the clinical benefit in subjects with advanced myeloid neoplasms. Type: Interventional Start Date: Feb 2023 |
Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's...
Massachusetts General Hospital
Alzheimer Disease
Family Members
Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits
(amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. Gamma waves
are important for memory, and in patients with AD, there are fewer gamma waves in the brain.... expand
Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits (amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. Gamma waves are important for memory, and in patients with AD, there are fewer gamma waves in the brain. The Tsai lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. A light and sound device was developed for humans that stimulates the brain at 40Hz that can be used safely at home. The goal of this study is to see if using this device can prevent dementia in people who are at risk for developing Alzheimer's disease. Type: Interventional Start Date: Oct 2023 |
A Study to Investigate the Safety and Tolerability of Ziftomenib in Combination With Venetoclax/Azacitidine,...
Kura Oncology, Inc.
Acute Myeloid Leukemia
Mixed Lineage Acute Leukemia
Mixed Lineage Leukemia Gene Mutation
Mixed Phenotype Acute Leukemia
Refractory AML
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic
activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3
for two different molecularly-defined arms, NPM1-m and KMT2A-r.
expand
This Phase 1 study will assess the safety, tolerability, and preliminary antileukemic activity of ziftomenib in combination with venetoclax and azacitidine (ven/aza), ven, and 7+3 for two different molecularly-defined arms, NPM1-m and KMT2A-r. Type: Interventional Start Date: Jul 2023 |
A Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-tumor...
Hoffmann-La Roche
Small Cell Lung Cancer
Neuroendocrine Carcinoma
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK),
pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3
parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with
advanced... expand
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and preliminary anti-tumor activity of RO7616789. The study will have 3 parts: Dose Escalation (Parts 1 and 2) and Dose Expansion (Part 3). Participants with advanced stage small cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC) will be enrolled in the study. Type: Interventional Start Date: Jan 2023 |
PRO1184 for Advanced Solid Tumors
ProfoundBio US Co.
Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Endometrial Cancer
Non-small Cell Lung Cancer
This study will test the safety, including side effects, and determine the characteristics of
a drug called PRO1184 in participants with solid tumors.
Participants will have solid tumor cancer that has spread through the body (metastatic) or
cannot be removed with surgery... expand
This study will test the safety, including side effects, and determine the characteristics of a drug called PRO1184 in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable). This study will have two parts. Part A of the study will find out how much and how frequently PRO1184 should be given to participants. Part B will use the dose and schedule found in Part A to find out how safe PRO1184 is and if it works to treat solid tumor cancers. Type: Interventional Start Date: Dec 2022 |
A Study of Safety and Efficacy of KFA115 Alone and KFA115 in Combination With Tislelizumab in Patients...
Novartis Pharmaceuticals
Carcinoma, Non-Small-Cell Lung
Cutaneous Melanoma
Carcinoma, Renal Cell
Carcinoma, Ovarian Epithelial
Nasopharyngeal Carcinoma
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115
in combination with tislelizumab in patients with select advanced cancers, and to identify
the maximum tolerated dose and/or recommended dose.
expand
The purpose of this study is to characterize the safety and tolerability of KFA115 and KFA115 in combination with tislelizumab in patients with select advanced cancers, and to identify the maximum tolerated dose and/or recommended dose. Type: Interventional Start Date: Oct 2022 |
Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants...
ModernaTX, Inc.
Advanced Solid Tumors
The primary goal of this study is to assess the safety and tolerability of mRNA-4359
administered alone and in combination with pembrolizumab.
expand
The primary goal of this study is to assess the safety and tolerability of mRNA-4359 administered alone and in combination with pembrolizumab. Type: Interventional Start Date: Aug 2022 |
ABC008 in Subjects With T-cell Large Granular Lymphocytic Leukemia (T-LGLL)
Abcuro, Inc.
T-cell Large Granular Lymphocytic Leukemia
An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic
Leukemia (T-LGLL)
expand
An open label, ascending dose study for adult subjects with T-cell Large Granular Lymphocytic Leukemia (T-LGLL) Type: Interventional Start Date: Sep 2022 |
Study to Evaluate EP547 in Subjects With Cholestatic Pruritus Due to Primary Biliary Cholangitis or Primary...
Escient Pharmaceuticals, Inc
Pruritus
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus
due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC)
expand
This phase 2 trial will evaluate the effects of EP547 in subjects with cholestatic pruritus due to Primary Biliary Cholangitis (PBC) or Primary Sclerosing Cholangitis (PSC) Type: Interventional Start Date: Oct 2022 |
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Eli Lilly and Company
Breast Neoplasms
The main purpose of this study is to measure how well imlunestrant works compared to standard
hormone therapy in participants with early breast cancer that is estrogen receptor positive
(ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken... expand
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years. Type: Interventional Start Date: Oct 2022 |
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of RO7303509 in Participants With...
Genentech, Inc.
Systemic Sclerosis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK)
of RO7303509 treatment in participants with systemic sclerosis (SSc) during a
multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of
study drug will... expand
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of RO7303509 treatment in participants with systemic sclerosis (SSc) during a multiple-ascending-dose (MAD) portion of the trial. In the MAD phase, increasing doses of study drug will be tested sequentially. For each dose tested, the MAD stage will consist of a treatment period of 12 weeks followed by either a safety follow-up period of 13 weeks or continued treatment in an optional open-label safety extension (OSE) stage of 52 weeks to assess the long-term safety. All patients in the OSE stage will receive RO7303509 and no patient will receive placebo. Type: Interventional Start Date: Jan 2023 |
Peanut Sublingual Immunotherapy (SLIT)-Tablet for Treatment of Peanut Allergy
ALK-Abelló A/S
Peanut Allergy
This clinical research study investigates the safety and tolerability of a peanut
SLIT-tablet.
expand
This clinical research study investigates the safety and tolerability of a peanut SLIT-tablet. Type: Interventional Start Date: Sep 2022 |
Study of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab...
Gilead Sciences
Triple Negative Breast Cancer
PD-L1 Positive
The primary objective of this study is to compare the progression-free survival (PFS) between
sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice
(TPC) and pembrolizumab in participants with previously untreated, locally advanced
inoperable... expand
The primary objective of this study is to compare the progression-free survival (PFS) between sacituzumab govitecan-hziy (SG) and pembrolizumab versus treatment of physician's choice (TPC) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (PD-L1). Type: Interventional Start Date: Jul 2022 |
Pediatric Influence of Cooling Duration on Efficacy in Cardiac Arrest Patients (P-ICECAP)
University of Michigan
Cardiac Arrest, Out-Of-Hospital
Hypothermia, Induced
Hypoxia-Ischemia, Brain
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of
induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest.
The study team hypothesizes that longer durations of cooling may improve either the
proportion... expand
This is a multicenter trial to establish the efficacy of cooling and the optimal duration of induced hypothermia for neuroprotection in pediatric comatose survivors of cardiac arrest. The study team hypothesizes that longer durations of cooling may improve either the proportion of children that attain a good neurobehavioral recovery or may result in better recovery among the proportion already categorized as having a good outcome. Type: Interventional Start Date: Aug 2022 |
A Study of TAK-062 in Treatment of Active Celiac Disease in Participants Attempting a Gluten-Free Diet
Takeda
Celiac Disease
The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small
intestinal damage due to gluten exposure, in participants with celiac disease (CeD)
attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo
controls.... expand
The main aim is to see how TAK-062 works to reduce celiac-related symptoms and improve small intestinal damage due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls. Type: Interventional Start Date: Jun 2022 |
Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients
Hal Chapman
Idiopathic Pulmonary Fibrosis
The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging
Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with
idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.
expand
The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis. Type: Interventional Start Date: Aug 2023 |
Study to Evaluate the Safety, Tolerability, PDs, and Efficacy of CNP-104 in Subjects With Primary Biliary...
COUR Pharmaceutical Development Company, Inc.
Primary Biliary Cholangitis
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety,
tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The
study consists of a 120 day primary study followed by a 20 month long-term safety and
durability... expand
This study is a Phase 2a First-in-Human (FIH) clinical trial to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of multiple ascending doses of CNP-104. The study consists of a 120 day primary study followed by a 20 month long-term safety and durability of response follow-up period. Type: Interventional Start Date: Jan 2022 |
A Study to Evaluate the Safety and Efficacy of ION373 in Patients With Alexander Disease (AxD)
Ionis Pharmaceuticals, Inc.
Alexander Disease
The purpose of this study is to evaluate the safety and efficacy of ION373 in improving or
stabilizing gross motor function across the full range of affected domains in patients with
AxD.
expand
The purpose of this study is to evaluate the safety and efficacy of ION373 in improving or stabilizing gross motor function across the full range of affected domains in patients with AxD. Type: Interventional Start Date: Jun 2021 |
A Study of Selpercatinib After Surgery or Radiation in Participants With Non-Small Cell Lung Cancer (NSCLC)
Loxo Oncology, Inc.
Carcinoma, Non-Small-Cell Lung
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is
effective and safe in delaying cancer return in participants with early-stage non-small cell
lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned... expand
The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years. Type: Interventional Start Date: Dec 2021 |
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast...
Hoffmann-La Roche
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants
with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or
metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease
progression... expand
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive, HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER-positive, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib or neratinib). 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. During Stage 1, participants in each cohort will be randomly assigned to treatment arms. Participants in the control or experimental arms who experience unacceptable toxicity, disease progression as determined by the investigator according to RECIST v1.1, or loss of clinical benefit as determined by the investigator during Stage 1 will be given the option of receiving a different treatment combination during Stage 2, provided they meet eligibility criteria and a treatment arm is open for enrollment. No Stage 2 treatment is currently available. Type: Interventional Start Date: Jun 2021 |
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