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A Study of ELI-002 7P in Subjects With KRAS/NRAS Mutated Solid Tumors
Elicio Therapeutics
Pancreatic Ductal Adenocarcinoma
Colorectal Cancer
KRAS G12D
KRAS G12R
KRAS G12V
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a
lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of
lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects
with... expand
This is a Phase 1/2 study to assess the safety and efficacy of ELI-002 7P immunotherapy (a lipid-conjugated immune-stimulatory oligonucleotide [Amph-CpG-7909] plus a mixture of lipid-conjugated peptide-based antigens [Amph-Peptides 7P]) as adjuvant treatment in subjects with solid tumors with mutated KRAS/NRAS. This study builds on the experience obtained with related product ELI-002 2P, which was studied in protocol ELI-002-001 under IND 26909. Type: Interventional Start Date: Apr 2023 |
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 |
A Safety and Efficacy Study of Treatment Combinations With and Without Chemotherapy in Adult Participants...
Arcus Biosciences, Inc.
Gastrointestinal Tract Malignancies
The purpose of this study is to evaluate the safety and preliminary clinical activity of
treatment combinations with and without chemotherapy in participants with locally advanced
unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will
consist... expand
The purpose of this study is to evaluate the safety and preliminary clinical activity of treatment combinations with and without chemotherapy in participants with locally advanced unresectable or metastatic gastric, GEJ, and esophageal adenocarcinoma. Chemotherapy will consist of FOLFOX (oxaliplatin, leucovorin, fluorouracil). Type: Interventional Start Date: Jun 2022 |
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 |
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 |
Short-Term Linvoseltamab Treatment, on Top of Chronic Dupilumab Treatment, for Adults With Severe Immunoglobulin...
Regeneron Pharmaceuticals
Food Allergy
This study is researching an experimental drug called linvoseltamab when combined with
another drug called dupilumab. The study is focused on patients who have IgE-mediated food
allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg,
certain... expand
This study is researching an experimental drug called linvoseltamab when combined with another drug called dupilumab. The study is focused on patients who have IgE-mediated food allergy. If the patient has an allergy, the immune system overreacts to an allergen (eg, certain foods such as peanuts, milk, shellfish) by producing antibodies called IgE. IgE antibodies are released by cells such as plasma cells. These antibodies and allergen bind to other cells that release chemicals, causing an allergic reaction. The aim of the study is to see how safe and tolerable linvoseltamab is when combined with dupilumab. The study is looking at several other research questions, including: - What side effects may happen from taking the study drugs - Whether linvoseltamab when combined with dupilumab has an effect on other types of antibodies in the blood at different times - How much study drug(s) is in the blood at different times Type: Interventional Start Date: May 2024 |
Reconnecting to Ourselves and Others in Virtual Meetings (ROOM)
Massachusetts General Hospital
Mood Disorders
Anxiety Disorders
Psychotic Disorders
This study aimed to determine the feasibility and acceptability of delivering Resilience
Training in multi-user virtual reality.
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This study aimed to determine the feasibility and acceptability of delivering Resilience Training in multi-user virtual reality. Type: Interventional Start Date: Sep 2020 |
PRO1107 in Patients With Advanced Solid Tumors
ProfoundBio US Co.
Endometrial Cancer
Ovarian Cancer
Triple Negative Breast Cancer
GastroEsophageal Cancer
Non-small Cell Lung Cancer
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety,
tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors.
This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B:
tumor... expand
This is a global, open-label, multicenter Phase 1/2 study to evaluate the safety, tolerability, PK, and antitumor activity of PRO1107 in patients with advanced solid tumors. This study consists of 2 parts, Part A: dose escalation and dose level expansion, and Part B: tumor specific expansion. Type: Interventional Start Date: Jan 2024 |
Elranatamab in R/R Multiple Myeloma
Massachusetts General Hospital
Refractory Multiple Myeloma
Relapse Multiple Myeloma
Multiple Myeloma
This research is being done to see if the study drug, elranatamab, reduces the risk of
disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory
multiple myeloma.
expand
This research is being done to see if the study drug, elranatamab, reduces the risk of disease progression (worsening disease) after idecabtagene vicleucel in relapsed refractory multiple myeloma. Type: Interventional Start Date: Mar 2024 |
AMX0035 and Progressive Supranuclear Palsy
Amylyx Pharmaceuticals Inc.
Progressive Supranuclear Palsy
PSP
Neurodegenerative Diseases
Atypical Parkinsonism
ORION Trial is a trial to evaluate the efficacy and safety of AMX0035 in participants with
Progressive Supranuclear Palsy (PSP), consisting of a randomized double blind placebo
controlled phase, followed by an optional open-label extension phase.
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ORION Trial is a trial to evaluate the efficacy and safety of AMX0035 in participants with Progressive Supranuclear Palsy (PSP), consisting of a randomized double blind placebo controlled phase, followed by an optional open-label extension phase. Type: Interventional Start Date: Dec 2023 |
IDEAL: Intended to Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels...
CymaBay Therapeutics, Inc.
Primary Biliary Cholangitis
To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in
Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to
Ursodeoxycholic Acid (UDCA)
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To Determine the Effects of Seladelpar on Normalization of Alkaline Phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) Type: Interventional Start Date: Sep 2023 |
Tocilizumab in Lung Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Lung Transplant
This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to
receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance
immunosuppression or placebo (sterile normal saline) plus standard triple maintenance
immunosuppression... expand
This is a trial in which 350 primary lung transplant recipients will be randomized (1:1) to receive either Tocilizumab (six doses over 20 weeks) plus standard triple maintenance immunosuppression or placebo (sterile normal saline) plus standard triple maintenance immunosuppression (Tacrolimus, Mycophenolate Mofetil, corticosteroids). The primary objective is to test the hypothesis that treatment with triple maintenance immunosuppression plus Tocilizumab (TCZ) is superior to triple maintenance immunosuppression plus placebo (saline) as defined by a composite endpoint of a) CLAD, b) listed for re-transplantation, and c) death Type: Interventional Start Date: Feb 2024 |
A Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986278 in Participants With Progressive...
Bristol-Myers Squibb
Progressive Pulmonary Fibrosis
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278
in Participants with Progressive Pulmonary Fibrosis.
expand
The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986278 in Participants with Progressive Pulmonary Fibrosis. Type: Interventional Start Date: Oct 2023 |
Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)
GB002, Inc.
Pulmonary Arterial Hypertension
The primary objective of the study is to determine the effect of seralutinib on improving
exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary
objective for this trial is to determine time to clinical worsening.
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The primary objective of the study is to determine the effect of seralutinib on improving exercise capacity in subjects with WHO Group 1 PAH who are FC II or III. The secondary objective for this trial is to determine time to clinical worsening. Type: Interventional Start Date: Dec 2023 |
A Study to Investigate Behavioral and Other Co-Occurring Outcomes With Epidiolex as Add-On Therapy in...
Jazz Pharmaceuticals
Tuberous Sclerosis Complex Associated Neuropsychiatric Disease
The purpose of this study is to investigate behavioral and other co-occurring outcomes with
EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis
complex (TSC) who experience seizures.
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The purpose of this study is to investigate behavioral and other co-occurring outcomes with EPID(I/Y)OLEX as an add-on therapy in participants aged 1 to 65 years with tuberous sclerosis complex (TSC) who experience seizures. Type: Interventional Start Date: Jun 2023 |
Mismatch vs. Standard Intervention During Memory Reconsolidation Blockade With Propranolol: Effect on...
Massachusetts General Hospital
Stress Disorders, Post-Traumatic
The proposed R21 project will attempt to further develop a novel intervention for
posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in
normal humans has shown that when a stable, consolidated memory is reactivated (i.e.,
retrieved) under... expand
The proposed R21 project will attempt to further develop a novel intervention for posttraumatic stress symptoms inspired by the science of memory reconsolidation. Work in normal humans has shown that when a stable, consolidated memory is reactivated (i.e., retrieved) under appropriate conditions, it reverts to an unstable state, a process referred to herein as deconsolidation. In such a state, the memory is susceptible to the action of various "amnestic" agents that may inhibit its reconsolidation, thereby weakening it. The β-adrenergic blocker propranolol (PPNL) possesses such amnestic properties. More recent research has found that in order to initiate deconsolidation, there must be a prediction error, or mismatch, between what is expected and what occurs when the memory is reactivated. Prior placebo-controlled, randomized clinical trials (PBO-RCT) from our laboratory have found that when propranolol is administered concomitant with the reactivation of a psychologically traumatic memory, the memory is weakened, as revealed by subsequent lower physiological (heart rate, skin conductance, facial electromyogram) responding during script-driven mental imagery. Clinical applicability was evaluated in a PBO-RCT, in which PTSD participants receiving propranolol underwent six weekly sessions of 10-20 min of "standard" (STD) traumatic memory reactivation stimulated by reading a narrative. At post-treatment, these participants showed a greater reduction of PTSD symptoms compared to participants who had taken PBO. The goal of the proposed study is to test whether intentionally incorporating innovative mismatch (MM) into traumatic memory reactivation can improve upon physiological responding during script-driven mental imagery. Participants will be randomized to one of 2 treatment arms: STD/PPNL and MM/PPNL. A baseline assessment will measure psychophysiological responsivity to script-driven mental imagery (target measure). PPNL will be administered 90-min prior to each of six weekly 10-20 min. traumatic memory reactivation sessions. In the MM condition, a different, unexpected mismatch (e.g., singing the narrative) will be incorporated into the reactivation. In the STD condition, the participant will read the narrative the same way each time. The focus of the R21 proposal will be to assess whether the MM/PPNL group shows lower subsequent physiological responses than the STD/PPNL group Type: Interventional Start Date: Jun 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 |
Avatrombopag vs. Placebo for CIT in GI Malignancies
Hanny Al-Samkari, MD
Gastrointestinal Cancer
Gastrointestinal Neoplasms
Chemotherapy-Induced Thrombocytopenia
The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus
placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with
gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy.
The names of the study... expand
The purpose of this study is to compare the efficacy of two study drugs, Avatrobopag versus placebo, to treat persistent Chemotherapy-Induced Thrombocytopenia (CIT) in patients with gastrointestinal (GI) malignancies receiving cytotoxic chemotherapy. The names of the study drugs involved in this study are: - Avatrombopag (a thrombopoietin receptor agonist) - Matching placebo Type: Interventional Start Date: Nov 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.
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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 Clinical Trial of Four Medicines (Elranatamab Plus Carfilzomib and Dexamethasone or Maplirpacept) in...
Pfizer
Multiple Myeloma
The main purpose of the study is to evaluate the safety and tolerability of the combination
of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept.
There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of
elranatamab... expand
The main purpose of the study is to evaluate the safety and tolerability of the combination of elranatamab and carfilzomib and dexamethasone or elranatamab and maplirpacept. There are 2 parts to this study. Part 1 will evaluate the safety and tolerability of elranatamab when given in combination with carfilzomib plus dexamethasone. Part 2 has 2 arms. The first will evaluate the safety and tolerability of elranatamab when given in combination with maplirpacept. The second will identify the optimal dose(s) of elranatamab plus maplirpacept. All study medicines are given over 4-week cycles. Everyone taking part in this study will receive elranatamab as a shot under the skin. Participants in Part 1 will also receive weekly carfilzomib as an IV infusion (given directly into a vein) and dexamethasone either by mouth (as a pill) or by IV infusion. Participants in Part 2 will receive elranatamab in combination with maplirpacept as an IV infusion (given directly into a vein) The investigators will examine the experiences of people receiving the study medicines. This will help determine if the study medicines are safe and can be used for multiple myeloma treatment. Participants will take part in this study for about 2 years after the first dose. Type: Interventional Start Date: Dec 2022 |
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
High Grade Epithelial Ovarian Cancer
Primary Peritoneal Carcinoma
Fallopian Tube Cancer
Endometrial 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). Type: Interventional Start Date: Dec 2022 |
Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Patients...
Stemline Therapeutics, Inc.
Breast Cancer
Metastatic Breast Cancer
This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the
RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib,
abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and... expand
This is a multicenter, Phase 1b/2 trial. The phase 1b part of the trial aims to determine the RP2D of elacestrant when administered in combination with alpelisib, everolimus, palbociclib, abemaciclib, and ribociclib. The Phase 2 part of the trial will evaluate the efficacy and safety of the various combinations in patients with ER+/HER2- advanced/metastatic breast cancer. Type: Interventional Start Date: Jan 2023 |
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With...
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 pembrolizumab 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 pembrolizumab 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 Tecovirimat for Human Monkeypox Virus
National Institute of Allergy and Infectious Diseases (NIAID)
Monkeypox
MPOX
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of
tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV
disease.
expand
A5418 is a randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive HMPXV disease. Type: Interventional Start Date: Sep 2022 |
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