PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT05368506: ZN-c3 for the Treatment of Metastatic Triple-Negative Breast Cancer and Advanced Ovarian Cancer
Official title: An Early Phase I Study of the Pharmacodynamics of WEE1 Inhibitor, ZN-c3, in Metastatic Solid Tumors
Conditions: Advanced Fallopian Tube Carcinoma
Advanced Ovarian Carcinoma
Advanced Primary Peritoneal Carcinoma
Anatomic Stage IV Breast Cancer AJCC v8
Metastatic Triple-Negative Breast Carcinoma
Stage III Fallopian Tube Cancer AJCC v8
Stage III Ovarian Cancer AJCC v8
Stage III Primary Peritoneal Cancer AJCC v8
Stage IV Fallopian Tube Cancer AJCC v8
Stage IV Ovarian Cancer AJCC v8
Stage IV Primary Peritoneal Cancer AJCC v8
Summary: This early phase I trial tests the safety and side effects of ZN-c3 in treating patients with triple-negative breast cancer or ovarian cancer that have spread to other parts of the body (metastatic or advanced). ZN-c3 is an enzyme inhibitor that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
Interventions:
description: Given PO
name: Wee1 Inhibitor ZN-c3
other_name: ZN c3
ZN-c3
ZNc3
type: Drug
Study arms:
design_group_description: Patients receive Wee1 inhibitor ZN-c3 PO QD on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (wee1 inhibitor ZN-c3)
design_group_type: Experimental
Sponsor: OHSU Knight Cancer Institute
Collaborators: Oregon Health & Science University
Drug name mappings:
name: Azenosertib
lang: EN
Clinical trial NCT07349160: Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Official title: Safety and Efficacy of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) for the Treatment of Advanced Solid Tumors
Conditions: Advanced Solid Tumors
Summary: A Study of Metabolically Armed Tumor-Infiltrating Lymphocytes (Meta10-TIL) Therapy for Patients With Advanced Solid Tumors
Interventions:
description: Each subject receive metabolically armed TIL cells by intravenous infusion.
name: Metabolically Armed TIL cells.
other_name: Meta10-TIL
type: Drug
Study arms:
design_group_description: Patients will receive a nonmyeloablative lymphodepletionl chemotherapy with cyclophosphamide and fludarabine before TIL cells infusion. Meta10-TIL cells will be infused on day 0.
design_group_title: Administration of Metabolically Armed tumor-infiltrating lymphocytes (Meta10-TIL).
design_group_type: Experimental
Sponsor: Cancer Hospital Chinese Academy of Medical Sciences
Collaborators: Leman Biotech Co., Ltd.
Drug name mappings:
name: Metabolically Armed Tumor-lnfiltrating Lymphocytes(Leman Biotech)
lang: EN
Clinical trial NCT04116164: Safety and Targeting of Anti-hk2 Antibody in mCRPC
Official title: A Phase 0 Study to Assess the Safety and Biodistribution of a Novel Radiolabeled Antibody Targeting Human Kallikrein-2 (hk2) in Subjects With Metastatic Castration-resistant Prostate Cancer.
Conditions: Castration-Resistant Prostatic Cancer
Metastatic Disease
Summary: This is an imaging trial, to develop h11B6 as a therapeutic radiopharmaceutical for men with mCRPC.
This imaging study will be conducted to confirm the safety and estimate the mass amount of antibody h11B6, and confirm in vivo tumor targeting of the antibody, using Indium-111 (111In) radiolabeled h11B6 in subjects with advanced prostate cancer. This study will also provide the dosimetric information crucial for Phase 1 therapy.
Interventions:
description: 4-6 mCi 111In labeled to 2 mg DOTA-h11B6; 0, 8 or 18 mg additional h11B6.
name: 111In-DOTA-h11B6
type: Drug
Study arms:
design_group_description: Three sub-cohorts in cohort 1 will receive one slow bolus IV injection of 2 mg 111In-DOTA-h11B6 with 0, 8 and 18 mg unlabeled h11B6 respectively.<br/>In cohort 2, up to 6 patients will receive a slow bolus IV injection of 2 mg 111In-DOTA_h11B6 with any unlabeled h11B6 as determined from cohort 1, and will be imaged at one time-point
design_group_title: Dosimetry and targeting
design_group_type: Experimental
Sponsor: SpectronRx
Collaborators: Invicro LLC
Tomopath Inc.
Janssen Research & Development LLC
Drug name mappings:
name: 111In-DOTA-h11B6
lang: EN
Clinical trial NCT05683964: Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Official title: Understanding the Interaction Between Androgen Receptor Signaling and Prostate-Specific Membrane Antigen Expression
Conditions: Prostate Adenocarcinoma
Prostate Cancer
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
Summary: The goal of this research study is to determine whether hormonal therapies used early in the course of prostate cancer could increase the amount of Prostate-Specific Membrane Antigen (PSMA) as detected by PET/CT scans for participants with recurrent prostate cancer. This study will measure PSMA levels using standard PET/CT scans and participants will receive standard-of-care androgen receptor antagonist monotherapy.
The names of the treatment interventions involved in this study are:
* Androgen receptor antagonist monotherapy.
* PSMA PET/CT scan
It is expected that about 15 people will take part in this research study.
Participation in this research study is expected to last about 4 weeks.
Interventions:
description: per standard care
name: Apalutamide [Erleada], darolutamide [Nubeqa], or enzalutamide [Xtandi]
type: Drug
description: Per standard care
name: Prostate-Specific Membrane Antigen (PSMA) PET/CT Scan
type: Diagnostic Test
Study arms:
design_group_description: * Participants will receive pre-determined doses of apalutamide, darolutamide, or enzalutamide per standard care.<br/>* Participants will undergo Prostate-Specific Membrane Antigen (PSMA) PET/CT scans at weeks 1 and 4.
design_group_title: Androgen Receptor Antagonist Monotherapy
design_group_type: Experimental
Sponsor: Beth Israel Deaconess Medical Center, Inc.
Collaborators: Dana-Farber Cancer Institute, Inc.
Drug name mappings:
name: 恩扎卢胺
lang: CN
name: Enzalutamide
lang: EN
name: エンザルタミド
lang: JP
name: 阿帕他胺
lang: CN
name: Apalutamide
lang: EN
name: アパルタミド
lang: JP
name: 达罗他胺
lang: CN
name: Darolutamide
lang: EN
name: ダロルタミド
lang: JP
Clinical trial NCT01764451: Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
Official title: Permeability MRI in Cerebral Cavernous Malformations Type 1 in New Mexico: Effects of Statins
Conditions: Cavernous Angioma, Familial
Cerebral Cavernous Malformations
Cerebral Cavernous Hemangioma
Summary: Cerebral cavernous malformations (CCMs) are clusters of abnormal blood vessels in the brain and spine. CCMs can bleed and cause strokes, seizures, and headaches. In some patients, CCMs affect the blood brain barrier (BBB). The BBB is the body's separation of blood and its contents in the brain from the brain tissue itself. Abnormal leakiness or permeability of this barrier can cause disease. We will measure the permeability (leakiness) of the BBB using a magnetic resonance imaging (MRI) technique called dynamic contrast-enhanced MRI (DCEMRI). The purpose of this study is to look at whether statin medications change the permeability (leakiness) of the blood brain barrier in CCM patients. Statin medications are used to lower cholesterol levels and prevent heart attack and stroke. In addition, this medication may decrease the risk of brain hemorrhage or bleeding in patients with CCM. This study will examine whether the permeability of the BBB changes following the administration of simvastatin for three months.
Interventions:
name: Simvastatin
other_name: Zocor
type: Drug
Study arms:
design_group_description: 20-40 mg tablet taken daily by mouth. Month 1: 20 mg; Months 2 and 3: 40 mg.
design_group_title: Simvastatin
design_group_type: Experimental
design_group_title: No Treatment
design_group_type: No Intervention
Sponsor: The University of New Mexico
Collaborators: National Institute of Neurological Disorders & Stroke
The University of California, San Francisco
Drug name mappings:
name: 辛伐他汀
lang: CN
name: Simvastatin
lang: EN
name: シンバスタチン
lang: JP
Clinical trial NCT05948683: Prosocial Effects of MDMA
Official title: Effects of Familiarity on Prosocial Effects of MDMA
Conditions: MDMA ('Ecstasy')
Social Interaction
Summary: In this study, the aim is to test the hypothesis that MDMA produces greater prosocial effects when administered in the presence of a familiar, compared to an unfamiliar, person
Interventions:
description: The stimulant MDMA
name: MDMA
type: Drug
description: Dextrose
name: Placebo
type: Drug
Study arms:
design_group_description: Participant engages in social interaction with 'familiar' partner under placebo
design_group_title: Familiar partner with placebo
design_group_type: Experimental
design_group_description: Participant engages in social interaction with 'familiar' partner under MDMA
design_group_title: Familiar partner with MDMA
design_group_type: Experimental
design_group_description: Participant engages in social interaction with 'unfamiliar' partner under placebo
design_group_title: Unfamiliar partner with placebo
design_group_type: Experimental
design_group_description: Participant engages in social interaction with 'unfamiliar' partner under MDMA
design_group_title: Unfamiliar partner with MDMA
design_group_type: Experimental
Sponsor: The University of Chicago
Collaborators: National Institute on Drug Abuse
National Institutes of Health
Drug name mappings:
name: 亚甲二氧甲基苯丙胺
lang: CN
name: Methylenedioxymetamfetamine
lang: EN
Clinical trial NCT04645602: Merck IIT: RRP Pembro and Lenvatinib
Official title: A Pilot Study of Lenvatinib in Combination With Pembrolizumab in HPV-associated Recurrent Respiratory Papillomatosis Patients
Conditions: Human Papilloma Virus
Recurrent Respiratory Papillomatosis
Pulmonary Disease
Summary: This research study is studying Lenvatinib in combination with Pembrolizumab in people with human papillomavirus (HPV)-associated recurrent respiratory papillomatosis (RRP).
The names of the study drugs involved in this study are:
* Pembrolizumab
* Lenvatinib
Interventions:
description: Pill taken by mouth, once daily.
name: Lenvatinib
other_name: Lenvima
type: Drug
description: Intravenous injection through a vein (IV).
name: Pembrolizumab
other_name: Keytruda
type: Drug
Study arms:
design_group_description: Participants will take:<br/>Lenvatinib - At a pre-determined dose daily during each 3 week study cycle up to 9 cycles<br/>Pembrolizumab - 200 mg infusion on Day 1 of each 3 week study cycle up to 35 cycles<br/>Participants will be given a drug diary and asked to document information in the drug diary about the study treatment.<br/>Participants will be asked to check their blood pressure 3x every week and document in a supplied diary.<br/>Participants will be followed up to one (1) year after study treatment.
design_group_title: Lenvatinib + Pembrolizumab
design_group_type: Experimental
Sponsor: Yale University
Collaborators: Merck Sharp & Dohme Corp.
Eisai, Inc.
Drug name mappings:
name: 帕博利珠单抗
lang: CN
name: Pembrolizumab
lang: EN
name: ペムブロリズマブ（遺伝子組換え）
lang: JP
name: 甲磺酸仑伐替尼
lang: CN
name: Lenvatinib mesylate
lang: EN
name: レンバチニブメシル酸塩
lang: JP
Clinical trial NCT04439721: γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse
Official title: Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Conditions: Leukemia, B-cell
Summary: Safety and Effectiveness of Donor γδT Cell Infusion to Prevent Relapsed/Refractory Leukemia Rescue Relapse After Allogeneic Hematopoietic Stem Cell Transplantation
Interventions:
description: γδT
name: γδT Cell infusion agent
type: Drug
Study arms:
design_group_description: γδT,Infusion,iv,0.5×10^6-8×10^7γδT /kg,once.
design_group_title: γδT
design_group_type: Experimental
Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Collaborators: The First Affiliated Hospital of Soochow University
Drug name mappings:
name: Donor γδT Cell(PersonGen BioTherapeutics)
lang: EN
Clinical trial NCT04121494: ChAdOx1 85A Aerosol Versus Intramuscular Vaccination in Healthy Adults (TB039)
Official title: A Phase I Clinical Trial to Compare the Safety and Immunogenicity of Candidate TB Vaccine ChAdOx1 85A Administered by the Aerosol Inhaled Route and the Intramuscular Route in Healthy Adult Subjects
Conditions: Mycobacterium Tuberculosis, Protection Against
Tuberculosis
Summary: This is a dose escalating and a paired-placebo design study to describe the safety and immunogenicity profile of candidate TB vaccine ChAdOx1 85A given by aerosol inhaled vaccination versus intramuscular (IM) vaccination in adult healthy volunteers.
It is postulated that the aerosol inhaled route is practical and feasible and has an acceptable safety profile, comparable to the systemic safety profile of the IM route of administration of ChAdOx1 85A in adult healthy volunteers, and that the aerosol inhaled route of administration will induce greater mucosal immunity and comparable systemic immunity when compared to the IM (systemic) route of administration in these volunteers.
Volunteers are followed on a regular basis for safety and immunogenicity, with blood analysis for biological safety tests and immune tests.
Interventions:
description: Aerosol administration through the Omron MicroAIR NE-U22 nebuliser
name: ChadOx1 85A - aerosol
type: Biological
description: Intramuscular administration
name: ChadOx1 85A - IM
type: Biological
Study arms:
design_group_description: BCG-vaccinated, 1x10^9 vp, aerosol
design_group_title: Group A
design_group_type: Experimental
design_group_description: BCG-vaccinated, 5x10^9 vp, aerosol
design_group_title: Group B
design_group_type: Experimental
design_group_description: BCG-vaccinated, 1x10^10 vp, aerosol
design_group_title: Group C
design_group_type: Experimental
design_group_description: BCG-vaccinated, highest tolerated dose aerosol + placebo IM; Randomized with Group E, blind
design_group_title: Group D
design_group_type: Experimental
design_group_description: BCG-vaccinated, highest tolerated dose IM + placebo aerosol; Randomized with Group D, blind
design_group_title: Group E
design_group_type: Experimental
design_group_description: BCG-non vaccinated, highest tolerated dose, aerosol
design_group_title: Group F
design_group_type: Experimental
Sponsor: Centre Hospitalier Universitaire Vaudois
Collaborators: University of Oxford
Drug name mappings:
name: ChAdOx1-85A
lang: EN
Clinical trial NCT04670055: A Study of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Official title: Clinical Trial for the Safety and Efficacy of Humanized BCMA-targeted CAR-T Cells Therapy for Refractory/Relapsed Multiple Myeloma
Conditions: Relapse Multiple Myeloma
Refractory Multiple Myeloma
Summary: Clinical Trial for the safety and efficacy of humanized BCMA-targeted CAR-T cells therapy for refractory/relapsed multiple myeloma
Interventions:
description: Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
name: BCMA Targeted CAR T-cells
other_name: BCMA Targeted CAR T-cells injection
type: Drug
Study arms:
design_group_description: Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
design_group_title: Administration of BCMA Targeted CAR T-cells
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: Anti BCMA CART cell therapy(Shanghai YaKe Biotechnology Co Ltd)
lang: EN
Clinical trial NCT00644137: GABA (Gamma Amino Butyric Acid) Medication for Tobacco
Official title: Pregabalin Given to Tobacco Users to Study Addiction
Conditions: Nicotine Dependence
Summary: The goal of this study is to examine the effects of a GABA (gamma amino butyric acid)-enhancing medication, pregabalin (300 mg/day), on smoking behavior, tobacco withdrawal and cigarette craving in smokers. We hypothesize that in smokers, pregabalin at 300 mg/day, will be more effective than placebo in decreasing smoking behavior and attenuating tobacco withdrawal and cigarette craving.
Interventions:
description: Help stop smoking
name: pregabalin
other_name: 300mg/day for pregabalin with smoking cigarettes
type: Drug
description: help stop smoking with study medication
name: cigarettes
type: Other
Study arms:
design_group_description: pregabalin 300mg/day given in conjunction with smoking cigarettes.
design_group_title: A
design_group_type: Experimental
design_group_description: cigarettes given in conjunction with pregabalin
design_group_title: 2
design_group_type: Experimental
Sponsor: Yale University
Collaborators: National Institute on Drug Abuse
US Department of Veterans Affairs (District of Columbia)
Drug name mappings:
name: 普瑞巴林
lang: CN
name: Pregabalin
lang: EN
name: プレガバリン
lang: JP
Clinical trial NCT02520882: 68Ga-NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
Official title: Safety and Diagnostic Performance of 68Gallium-labeled NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
Conditions: Glioma
Summary: This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Interventions:
description: 68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans
name: 68Ga-NOTA-Aca-BBN
other_name: 68Ga-NOTA-Aca-BBN(7-14)
type: Drug
name: PET/CT
type: Device
Study arms:
design_group_description: The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.
design_group_title: 68Ga-NOTA-Aca-BBN(7-14) PET/CT
design_group_type: Experimental
Sponsor: Peking Union Medical College Hospital
Collaborators: National Institute For Biomedical Imaging And Bioengineering (Nibib)
Drug name mappings:
name: Gallium-68-NOTA-Aca-BBN(7-14)
lang: EN
Clinical trial NCT04160052: Venetoclax and Azacitidine for the Treatment of High-Risk Recurrent or Refractory Myelodysplastic Syndrome
Official title: Phase I/II of Venetoclax in Combination With Azacitidine in Treatment Naïve and Relapse Refractory High Risk MDS Individuals"
Conditions: Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome
Recurrent Myelodysplastic Syndrome
Refractory Myelodysplastic Syndrome
Therapy-Related Myelodysplastic Syndrome
Summary: This phase I/II trial studies the side effects and best dose of venetoclax when given together with azacitidine in treating patients with high-risk myelodysplastic syndrome that has come back (recurrent) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as venetoclax and azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Interventions:
description: Given SC or IV
name: Azacitidine
other_name: 5 AZC
5-AC
5-AZC
5-Azacytidine
Azacytidine
Azacytidine, 5-
Ladakamycin
Mylosar
Onureg
U-18496
Vidaza
type: Drug
description: Given PO
name: Venetoclax
other_name: ABT-0199
ABT-199
ABT199
GDC-0199
RG7601
Venclexta
Venclyxto
type: Drug
Study arms:
design_group_description: Patients receive venetoclax orally PO QD on days 1-7 or 1-14 and azacitidine SC or IV over 15 minutes on days 1-5. Cycles repeat every 4-8 weeks in the absence of disease progression or unacceptable toxicity.
design_group_title: Treatment (venetoclax, azacitidine)
design_group_type: Experimental
Sponsor: The University of Texas MD Anderson Cancer Center
Collaborators: National Cancer Institute
Drug name mappings:
name: 维奈克拉
lang: CN
name: Venetoclax
lang: EN
name: ベネトクラクス
lang: JP
name: 阿扎胞苷
lang: CN
name: Azacitidine
lang: EN
name: アザシチジン
lang: JP
Clinical trial NCT04808037: Blmf, Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Official title: A Phase 1/2 Study of Belantamab Mafodotin in Combination With Lenalidomide and Dexamethasone in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma
Conditions: Multiple Myeloma
Summary: This is a phase 1/2, open label, study designed to assess the safety and clinical activity of different Belantamab Mafodotin doses in combination with lenalidomide and dexamethasone.
Interventions:
description: Belantamab mafodotin in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed Multiple Myeloma transplant-ineligible
name: Belantamab mafodotin
other_name: Blenrep
type: Drug
Study arms:
design_group_description: 12 patients are anticipated to receive Belantamab Mafodotin 2.5 Q8W = 2.5 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone
design_group_title: Cohort 1, First Part
design_group_type: Experimental
design_group_description: 12 patients are anticipated to receive Belantamab Mafodotin 1.9 Q8W = 1.9 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone
design_group_title: Cohort 2, First Part
design_group_type: Experimental
design_group_description: 12 patients are anticipated to receive Belantamab Mafodotin 1.4 Q8W = 1.4 mg/kg on Day 1 of every other 28-day cycle, in combination with Lenalidomide and Dexamethasone
design_group_title: Cohort 3, First Part
design_group_type: Experimental
design_group_description: 15 patients are anticipated to receive Belantamab Mafodotin in the Recommended Phase 2 Dose, in combination with Lenalidomide and Dexamethasone.<br/>In this Arm the ocular toxicity will be graded according to the Dose Modification Guidelines for Corneal-Related Adverse Events Associated with belantamab mafodotin
design_group_title: Group A, Second Part
design_group_type: Experimental
design_group_description: 15 patients are anticipated to receive Belantamab Mafodotin in the Recommended Phase 2 Dose, in combination with Lenalidomide and Dexamethasone.<br/>In this Arm the ocular toxicity will be graded according to the Dose modification guidance based on visual acuity
design_group_title: Group B, Second Part
design_group_type: Experimental
Sponsor: Hellenic Society of Cardiology
Collaborators: GSK Plc
Drug name mappings:
name: 来那度胺
lang: CN
name: Lenalidomide
lang: EN
name: レナリドミド水和物
lang: JP
name: 玛贝兰妥单抗
lang: CN
name: Belantamab mafodotin
lang: EN
name: ベランタマブ マホドチン（遺伝子組換え）
lang: JP
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP