PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT02980341: Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer
Official title: Phase 1/2, Multicenter, Open-label, Multiple-Dose First-in-human Study of U3-1402, in Subjects With HER3 Positive Metastatic Breast Cancer
Conditions: Metastatic Breast Cancer
Summary: This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer.
The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.
Interventions:
description: U3-1402 consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)
name: Patritumab Deruxtecan
other_name: U3-1402
type: Drug
Study arms:
design_group_description: Participants receive U3-1402 from 1.6 mg/kg to 8.0 mg/kg, administered via intravenous (IV) solution at 3-week intervals.
design_group_title: Dose Escalation Part
design_group_type: Experimental
design_group_description: Participants receive 1 of 5 different U3-1402 dosing regimens, administered via IV solution at 2 or 3-week intervals at doses at or lower than those studied in the Dose Escalation Part.
design_group_title: Dose Finding Part
design_group_type: Experimental
design_group_description: Participants with HER3 high, HER2 negative, HR positive status receive 4.8 mg/kg or 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 low, HER2 negative, HR positive status receive 6.4 mg/kg of U3-1402 administered via intravenous (IV) solution at 3-week intervals. Participants with HER3 high, HER2 negative, HR negative status receive 6.4 mg/kg of U3-1402 administration via intravenous (IV) solution at 3-week intervals.
design_group_title: Dose Expansion Part
design_group_type: Experimental
Sponsor: Daiichi Sankyo Co., Ltd.
Collaborators: Merck Sharp & Dohme LLC
Daiichi Sankyo Co., Ltd.
Drug name mappings:
name: 德帕瑞妥单抗
lang: CN
name: Patritumab Deruxtecan
lang: EN
Clinical trial NCT04818281: Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults
Official title: Phase I Study Evaluating the Basic Pharmacological and Toxicological Effects of the Protective VLP Vaccine Developed Against SARS-CoV-2 in Healthy Participants, Administered as Two Injections Subcutaneously, in Two Different Dosages.
Conditions: Covid19
Summary: This is a VLP SARS-CoV-2 vaccine study of a vaccine developed in Turkey and manufactured according to Good Manufacturing Practices (GMP) requirements. Preclinical toxicology studies on experimental animals are to be concluded. The purpose of this Phase I study is to examine the safety, tolerability, and immunogenicity of the protective VLP vaccine against SARS-CoV-2, which will be administered by a double-blind, randomized method, in two different doses (low dose and high dose).
Interventions:
description: VLP adjuvanted vaccine
name: SARS-CoV-2 VLP Vaccine
type: Biological
description: 0.9% NaCl
name: Placebo
type: Biological
Study arms:
design_group_description: 12 participants will receive 10 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
design_group_title: Low-Dose Group (Group A)
design_group_type: Experimental
design_group_description: 12 participants will receive 40 µg VLP vaccine (adjuvanted with alum and CpGODN-K3)
design_group_title: High-Dose Group (Group B)
design_group_type: Experimental
design_group_description: 12 participants will receive 1 ml of 0.9% sodium chloride (NaCl)
design_group_title: Placebo Group
design_group_type: Placebo Comparator
Sponsor: Türkiye Bilimsel ve Teknolojik Arastirma Kurumu
Collaborators: Türkiye Bilimsel ve Teknolojik Arastirma Kurumu
Nobelpharma Co., Ltd.
Monitor Medikal Arastirma Ve Danismanlik Ticaret Ltd. Sirketi
Drug name mappings:
name: SARS-CoV-2 VLP Vaccine(Nobel Pharmaceuticals)
lang: EN
Clinical trial NCT00521248: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Official title: Buprenorphine for the Treatment of Neonatal Abstinence Syndrome
Conditions: Neonatal Abstinence Syndrome
Summary: Neonatal abstinence syndrome is a disease that affects children who were exposed to opioid drugs prior to birth. Commonly used treatments at present include morphine or tincture of opium. Buprenorphine is a drug used in adults to treat narcotic dependence, but has not been used for Neonatal Abstinence Syndrome. This trial is designed to see if the use of sublingual (under the tongue) buprenorphine is able to be used safely and easily in newborns with the neonatal abstinence syndrome. Secondary goals will be to see if treatment with buprenorphine is associated shorter stays in the hospital and fewer days of treatment than the use of standard therapy. Another secondary goal will be to understand buprenorphine concentration in the blood of babies treated with the drug (this is called "pharmacokinetics").
Interventions:
description: sublingual buprenorphine administered every 8 hours, titrated to control of abstinence symptoms
name: buprenorphine
other_name: Buprenex (buprenorphine)
type: Drug
description: 0.4 mg/kg/day morphine every 4 hours
name: Oral morphine solution
other_name: morphine
type: Drug
Study arms:
design_group_description: Oral morphine solution
design_group_title: Oral morphine solution
design_group_type: Active Comparator
design_group_description: Sublingual buprenorphine
design_group_title: Buprenorphine
design_group_type: Experimental
Sponsor: Thomas Jefferson University
Collaborators: National Institute on Drug Abuse
Drug name mappings:
name: 盐酸丁丙诺啡
lang: CN
name: Buprenorphine Hydrochloride
lang: EN
name: ブプレノルフィン塩酸塩
lang: JP
Clinical trial NCT03154775: Study of Safety and Efficacy of C-CAR011 in B-NHL Patients
Official title: Study of Safety and Efficacy of Anti-CD19 Chimeric Antigen Receptor T Cell(C-CAR011) Treatment in Subjects With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
Conditions: Refractory or Relapsed Non-Hodgkin Lymphoma
Summary: This is a single arm, single-center, non-randomized study to evaluate the safety and efficacy of C-CAR011 therapy in relapsed or refractory B cell Non-Hodgkin Lymphoma (NHL).
Interventions:
description: Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
name: C-CAR011
other_name: Anti-CD19 Chimeric Antigen Receptor T cell
type: Biological
Study arms:
design_group_description: Lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene
design_group_title: C-CAR011
design_group_type: Experimental
Sponsor: Shanghai Cellular Biopharmaceutical Group Ltd.
Collaborators: Shanghai Tongji Hospital
Drug name mappings:
name: CBM.CD19嵌合抗原受体T细胞注射液(Chinese People's Liberation Army General Hospital)
lang: CN
name: C-CAR011
lang: EN
Clinical trial NCT04476966: Bioequivalence Study of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan)
Official title: An Open Label Randomized, Single Dose, Three Way Three Sequence Two Treatment Partial Replicate Crossover Bioequivalence Study to Determine the Bioequivalence of Mirabegron From Bladogra 25 mg Extended Release Tablets (Multi-Apex for Pharmaceutical Industries, Egypt) Versus Myrbetriq 25 mg Extended Release Tablets (Marketed by Astellas Pharma US, Inc, Product of Japan) in Healthy Human Volunteers Under Fasting Condition.
Conditions: Healthy
Summary: An open label randomized, single dose, three way three sequence two treatment partial replicate crossover study to determine the bioequivalence of Mirabegron from Bladogra 50 mg Extended Release film coated tablets (Man by Multi-Apex for pharmaceutical Industries -S.A.E for Apex pharma company, Egypt) and Myrbetriq 50 mg Extended Release tablets (Marketed by Astellas Pharma US, Inc, Product of Japan) after a single oral dose administration of each to healthy adults under fasting conditions.
Interventions:
description: 1 tablet contains 25 mg Mirabegron
name: Bladogra
other_name: Myrbetriq
type: Drug
description: 1 tablet contains 25 mg Mirabegron
name: Myrbetriq (first dosing)
other_name: Myrbetriq
type: Drug
description: 1 tablet contains 25 mg Mirabegron
name: Myrbetriq (second dosing)
other_name: Myrbetriq
type: Drug
Study arms:
design_group_description: Test drug (Bladogra)1 extended release tablet contains 25 mg Mirabegron
design_group_title: T test
design_group_type: Experimental
design_group_description: Reference drug (Myrbetriq)1 extended release tablet contains 25 mg Mirabegron (first dose)
design_group_title: B reference (first dose)
design_group_type: Active Comparator
design_group_description: Reference drug (Myrbetriq)1 extended release tablet contains 25 mg Mirabegron (second dose)
design_group_title: B reference (second dose)
design_group_type: Active Comparator
Sponsor: Genuine Research Center - Grc
Collaborators: Multi/Apex Pharma for Pharmaceuticals Industries
Drug name mappings:
name: 米拉贝隆
lang: CN
name: Mirabegron
lang: EN
name: ミラベグロン
lang: JP
Clinical trial NCT04903080: HER2-specific Chimeric Antigen Receptor (CAR) T Cells for Children With Ependymoma
Official title: Phase 1 Trial of Autologous HER2-specific CAR T Cells in Pediatric Patients With Refractory or Recurrent Ependymoma
Conditions: Ependymoma
Summary: This is a Phase I study to evaluate the safety profile of a type of immune therapy called HER2 CAR T cells (short for HER2 chimeric antigen receptor T cells). In addition to looking for side effects, we will study how well this treatment works against a brain tumor called ependymoma that has come back after treatment (recurrent) or has not responded well to treatment (progressive) in children. The HER2 CAR T cells used in this trial are made from the patient's own blood. A new gene, called the HER2 CAR, will be inserted into patient's T cells to allow them recognize a protein on the tumor called HER2. These HER2-specific CAR T cells may be able to target and kill ependymoma tumors that express HER2. This research is also studying how doable it is to provide this type of CAR T cell treatment to children being treated at different hospitals.
Interventions:
description: HER2 CAR (Chimeric Antigen Receptor) T cells are T cells that have been genetically engineered to target the protein HER2 for the treatment of cancer.
name: HER2 Specific CAR T Cell
type: Biological
Study arms:
design_group_description: Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1. Patients receive HER2 CAR T cells IV on Day 0. Treatment repeats every 8 to 12 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (HER2 CAR T cells), Phase I Arm
design_group_type: Experimental
design_group_description: Patients receive lymphodepletion chemotherapy with cyclophosphamide IV daily on Days -7 to -6 and fludarabine IV daily on Days -5 to -1. Patients receive HER2 CAR T cells IV on Day 0 followed by surgical tumor resection 4-6 weeks following HER2 CAR T cell infusion. Treatment repeats every 8 to 15 weeks for 2 additional cycles in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (HER2 CAR T cells), Surgical Arm
design_group_type: Experimental
Sponsor: The Children's Oncology Group Foundation, Inc.
Collaborators: National Cancer Institute
Baylor College of Medicine
Texas Children's Cancer & Hematology Centers
Drug name mappings:
name: Autologous-HER2-specific-T-cells(Baylor College of Medicine)
lang: EN
Clinical trial NCT07158905: AV-1980R (Tau Vaccine) in Preclinical Alzheimer's Disease (TAURUS-1980)
Official title: A Phase I, Randomized, Double-Blind Study to Evaluate the Safety and Tolerability of AV-1980R in Participants With Preclinical Alzheimer's Disease
Conditions: Alzheimer Disease
Preclinical Alzheimer's Disease
Summary: This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose-escalating trial to evaluate the safety, tolerability, and immune response of AV-1980R, an investigational vaccine targeting tau protein, in participants with preclinical Alzheimer's disease. Up to 48 cognitively unimpaired adults aged 65-80 with biomarker evidence of early Alzheimer's disease will be enrolled into three ascending dose cohorts. The study is designed as a secondary prevention trial to test whether therapeutic immunization at the preclinical stage is safe, induces an immune response, and, exploratorily, may favorably affect biomarkers associated with disease progression.
Interventions:
description: MultiTEP-based investigational tau vaccine formulated with the adjuvant. The vaccine is designed to elicit anti-tau antibodies in participants with preclinical Alzheimer's disease.
name: AV-1980R 20 µg
type: Biological
description: MultiTEP-based tau vaccine formulated with the adjuvant, 60 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.
name: AV-1980R 60 µg
type: Biological
description: MultiTEP-based tau vaccine formulated with the adjuvant, 180 µg per dose; intramuscular injections at Weeks 0, 4, 12, and 36; secondary-prevention immunotherapy in preclinical AD.
name: AV-1980R 180 µg
type: Biological
description: 10 mM phosphate buffer formulated with the adjuvant; intramuscular injections at Weeks 0, 4, 12, and 36; no active antigen.
name: Placebo
type: Other
Study arms:
design_group_description: Participants receive 20 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.
design_group_title: AV-1980R 20 µg Arm
design_group_type: Experimental
design_group_description: Participants receive 60 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.
design_group_title: AV-1980R 60 µg Arm
design_group_type: Experimental
design_group_description: Participants receive 180 µg AV-1980R intramuscularly at Weeks 0, 4, 12, and 36.
design_group_title: AV-1980R 180 µg Arm
design_group_type: Experimental
design_group_description: Participants receive placebo injections (10 mM phosphate buffer with the adjuvant, no antigen) at Weeks 0, 4, 12, and 36.
design_group_title: Placebo Arm
design_group_type: Placebo Comparator
Sponsor: The Institute for Molecular Medicine
Collaborators: National Institute on Aging
Drug name mappings:
name: AV-1980R
lang: EN
Clinical trial NCT00921661: Study of Intravenous Aflibercept in Combination With FOLFIRI in Japanese Patients With Metastatic Colorectal Cancer
Official title: A Dose-escalation Study of the Safety, Tolerability, and Pharmacokinetics of Intravenous Aflibercept in Combination With Intravenous Irinotecan/5-fluorouracil/Isovorin (FOLFIRI) Administered Every 2 Weeks in Patients With Metastatic Colorectal Cancer
Conditions: Colorectal Neoplasms
Neoplasm Metastasis
Summary: The primary objective is to determine the dose of aflibercept to be further studied in combination with irinotecan/5-fluorouracil/isovorin (FOLFIRI) in Japanese patients with metastatic colorectal cancer.
Secondary objectives of this study are to assess the safety profile of aflibercept, to determine the pharmacokinetics of aflibercept, to make a preliminary assessment of antitumor effects.
Interventions:
description: IV infusion
name: AVE0005 (aflibercept)
type: Drug
Study arms:
design_group_title: AVE0005 (aflibercept)
design_group_type: Experimental
Sponsor: Sanofi
Collaborators: Regeneron Pharmaceuticals, Inc.
Drug name mappings:
name: 阿柏西普
lang: CN
name: Aflibercept
lang: EN
name: アフリベルセプト（遺伝子組換え）
lang: JP
Clinical trial NCT00529386: Botox for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Official title: A Prospective Pilot Study to Evaluate the Safety and Efficacy of Botox™ for the Treatment of Men Diagnosed With Chronic Prostatitis/Chronic Pelvic Pain Syndrome
Conditions: Prostatitis
Chronic Pain Syndrome
Summary: The objective of this study is to evaluate the safety and efficacy of intraprostatic injection of Botox for the treatment of men diagnosed with chronic nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS).
Interventions:
description: 300 units
name: Botox
other_name: Botulinem toxin
type: Drug
Study arms:
design_group_description: 300 IU botox
design_group_title: Botox
design_group_type: Experimental
Sponsor: Queen's University
Collaborators: Allergan UC
Drug name mappings:
name: A型肉毒毒素
lang: CN
name: Onabotulinumtoxin A
lang: EN
name: A 型ボツリヌス毒素
lang: JP
Clinical trial NCT02834611: Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Official title: Phase I Study of C6 Ceramide NanoLiposome in Patients With Advanced Solid Tumors
Conditions: Cancer
Carcinoma
Solid Tumors
Tumor
Summary: This study is a dose escalation study of Ceramide NanoLiposome in patients with advanced solid tumors.
Interventions:
description: Intravenous administration of Ceramide NanoLiposome
name: Ceramide NanoLiposome
type: Drug
Study arms:
design_group_description: Dose escalation of Ceramide NanoLiposome
design_group_title: Ceramide NanoLiposome
design_group_type: Experimental
Sponsor: PendreaBio Inc.
Collaborators: National Cancer Institute
National Institutes of Health
Drug name mappings:
name: Ceramide NanoLiposome(Keystone Nano, Inc.)
lang: EN
Clinical trial NCT04169321: Granzyme B PET Imaging Drug as a Predictor of Immunotherapy Response to Checkpoint Inhibitors
Official title: First in Human Safety of [68Ga]-NOTA-hGZP- PET Imaging in Subjects Receiving Checkpoint Inhibitor Immunotherapy
Conditions: Solid Tumor, Unspecified, Adult
Lymphoma
Summary: First in Human Safety of [68Ga]-NOTA-hGZP PET Imaging in subjects with cancer undergoing treatment with a checkpoint inhibitor either as a monotherapy of in combination I-O therapy
Interventions:
description: [68Ga]-NOTA-hGZP is a PET imaging agent.
name: Single Arm
other_name: CSB-111
[68Ga]-NOTA-hGZP
type: Drug
Study arms:
design_group_description: All participants will receive a mass dose of 40 μg or less of [68Ga]-NOTA-hGZP (radioactivity dose of 3 mCi to 8 mCi) and have a PET and CT scan.
design_group_title: Single Arm
design_group_type: Experimental
Sponsor: Cytosite Biopharma, Inc.
Collaborators: The General Hospital Corp.
Chang Gung Memorial Hospital
The University of Alabama at Birmingham
Drug name mappings:
name: Gallium-68 NOTA hGZP
lang: EN
Clinical trial NCT01026558: A Study Evaluating the Pharmacokinetics of Ceftobiprole When Taken by Obese Patients
Official title: Open-Label, Single Dose, Parallel Group Pharmacokinetic Study of Ceftobiprole in Morbidly Obese and Non-Obese Patients
Conditions: Obesity
Staphylococcal Skin Infections
Streptococcal Infections
Summary: The primary objective of this study is to compare the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole in morbidly obese patients and non-obese patients. The secondary objectives are to assess the pharmacodynamics (the study of the action or effects a drug has on the body) and to assess safety and tolerability of ceftobiprole in order to support dosing recommendations in the morbidly obese population.
Interventions:
description: Ceftobiprole, 500 mg as single iv infusion over 2 hours
name: Ceftobiprole
type: Drug
Study arms:
design_group_description: Ceftobiprole 500 mg single-dose over 2 hours.
design_group_title: Ceftobiprole (not morbidly obese subjects)
design_group_type: Active Comparator
design_group_description: Ceftobiprole 500 mg single-dose over 2 hours.
design_group_title: Ceftobiprole (morbidly obese subjects)
design_group_type: Experimental
Sponsor: Basilea Pharmaceutica AG
Collaborators: Johnson & Johnson Pharmaceutical Research & Development LLC
Drug name mappings:
name: 头孢比罗酯钠
lang: CN
name: Ceftobiprole Medocaril Sodium
lang: EN
Clinical trial NCT03216954: Influence of n-Acetylcysteine Maintenance on Alcohol Effects
Official title: A Human Laboratory Study of n-Acetylcysteine for Alcohol Use Disorder
Conditions: Alcohol Use Disorder
Summary: This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
Interventions:
description: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
name: Alcohol
type: Drug
description: Subjects will receive placebo capsules
name: Placebos
type: Drug
description: Subjects will receive n-acetyl cysteine capsules
name: N-acetyl cysteine
type: Drug
Study arms:
design_group_description: Subjects will receive oral placebo capsules two times daily.
design_group_title: Placebo
design_group_type: Placebo Comparator
design_group_description: Subjects will receive 0.6 g oral n-acetylcysteine two times daily.
design_group_title: Low Dose n-Acetylcysteine
design_group_type: Experimental
design_group_description: Subjects will receive 1.2 g oral n-acetylcysteine two times daily.
design_group_title: High Dose n-Acetylcysteine
design_group_type: Experimental
Sponsor: University of Kentucky
Collaborators: National Institute on Alcohol Abuse & Alcoholism
Drug name mappings:
name: 乙酰半胱氨酸
lang: CN
name: Acetylcysteine
lang: EN
name: アセチルシステイン
lang: JP
Clinical trial NCT01864083: FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Official title: FACBC PET and PEM as a Staging Tool and Indicator of Therapeutic Response in Breast Cancer Patients
Conditions: Breast Cancer
Summary: This study has been designed to help us determine if FACBC PET or PEM can accurately evaluate how far the breast cancer has spread in the breast. Also, to help determine if FACBC PET or PEM can accurately measure your response to chemotherapy.
Interventions:
name: Positron Emission Tomography (PET)
type: Procedure
name: Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)
type: Drug
name: Positron emission mammography (PEM) When available
type: Procedure
name: MR
type: Procedure
Study arms:
design_group_description: Breast MR and FACBC PET/PEM will be scheduled within one week of each other. Breast MR is a standard clinical examination and will be performed as standard.
design_group_title: Local staging patients
design_group_type: Experimental
design_group_description: Baseline FACBC PET/PEM will be scheduled within 1 week of beginning neoadjuvant therapy. A repeat FACBC PET/PEM will be scheduled after the conclusion of neoadjuvant therapy, and before definitive surgical management.
design_group_title: Neoadjuvant chemotherapy patients
design_group_type: Experimental
Sponsor: Memorial Sloan Kettering Cancer Center
Collaborators: GE Healthcare Holdings, Inc.
Drug name mappings:
name: [18F]氟氨基丁酸
lang: CN
name: Fluciclovine 18F
lang: EN
name: フルシクロビン（18F）
lang: JP