PatSnap/clinical-trial huggingface dataset:
Clinical trial NCT04827953: Study to Evaluate the Safety and Efficacy of Treatment With NLM-001 and Standard Chemotherapy Plus Zalifrelimab in Patients With Advanced Pancreatic Cancer
Official title: Phase Ib/IIa Study to Evaluate Safety and Efficacy of Treatment With the Hedgehog Inhibitor NLM-001 and Chemotherapy (Gemcitabine and Nab-Paclitaxel) Plus Zalifrelimab as First Line Treatment in Patients With Advanced Pancreatic Cancer
Conditions: Pancreatic Ductal Adenocarcinoma
Summary: In order to improve the survival rates and decrease progression of pancreatic advanced cancer, this study aims to evaluate the first line treatment approved for this disease (gemcitabine plus nab-paclitaxel) in combination with two experimental drugs, an inhibitor of the signaling pathway of Hedgehog and an immunotherapy drug able of blocking the CTLA-4 receptor.
Interventions:
description: Gemcitabine 1000 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).
name: Gemcitabine
type: Drug
description: Nab-Paclitaxel 125 mg/m2 IV on days 1, 8 and 15 (conventional chemotherapy).
name: Nab paclitaxel
type: Drug
description: NLM-001 will be administered three cycles consecutively followed by two rest cycles.
name: NLM-001
type: Drug
description: Zalifrelimab administration each 6 weeks.
name: Zalifrelimab
type: Drug
Study arms:
design_group_description: Conventional Chemotherapy (Gemcitabine + nab-paclitaxel) plus NLM-001 plus Zalifrelimab
design_group_title: Investigational treatment
design_group_type: Experimental
Sponsor: Nelum Corp.
Collaborators: Agenus, Inc.
Apices Soluciones SL
Drug name mappings:
name: 白蛋白结合型紫杉醇
lang: CN
name: Albumin-Bound Paclitaxel
lang: EN
name: パクリタキセル(JAN)
lang: JP
name: 盐酸吉西他滨
lang: CN
name: Gemcitabine Hydrochloride
lang: EN
name: ゲムシタビン塩酸塩
lang: JP
name: 泽弗利单抗
lang: CN
name: Zalifrelimab
lang: EN
name: NLM-001
lang: EN
Clinical trial NCT06206837: A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
Official title: AN INTERVENTIONAL SAFETY AND EFFICACY PHASE 1B/2, OPEN-LABEL STUDY TO INVESTIGATE TOLERABILITY, PK, AND ANTITUMOR ACTIVITY OF VEPDEGESTRANT (ARV-471/PF-07850327), AN ORAL PROTEOLYSIS TARGETING CHIMERA, IN COMBINATION WITH PF-07220060 IN PARTICIPANTS AGED 18 YEARS AND OLDER WITH ER+/HER2- ADVANCED OR METASTATIC BREAST CANCER
Conditions: Breast Cancer
Summary: The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer. This type of cancer would have spread from where it started (breast) to other parts of the body and would be tough to treat. The study is seeking for participants who have breast cancer that:
* is hard to treat (advanced) and may have spread to other organs (metastatic).
* is sensitive to hormonal therapy (it is called estrogen receptor positive).
* is no longer responding to treatments taken before starting this study.
All the participants will receive vepdegestrant and PF-07220060. Both medicines will be taken by mouth. The medicines will be taken at home. The experience of people receiving the study medicines will be studied. This will help see if the study medicines are safe and effective. Participants will continue to take vepdegestrant and PF-07220060 until:
* their cancer is no longer responding, or
* side effects become too severe. They will have visits at the study clinic about every 4 weeks.
Interventions:
description: Daily oral dosages of vepdegestrant continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
name: vepdegestrant
other_name: ARV-471 / PF07850327
type: Drug
description: Daily oral dosages of PF-07220060 continuously, dose escalation/de-escalation in Phase 1b until recommended phase 2 dose (RP2D) determined, cycles lasting 28 days
name: PF-07220060
type: Drug
Study arms:
design_group_description: vepdegestrant administered orally once daily (QD) continuously and PF-07220060 administered orally twice daily (BID) continuously on 28-day cycles
design_group_title: vepdegestrant in combination with PF-07220060
design_group_type: Experimental
Sponsor: Pfizer Inc.
Collaborators: Arvinas Estrogen Receptor, Inc.
Drug name mappings:
name: Atirmociclib
lang: EN
name: 维普地司他
lang: CN
name: Vepdegestrant
lang: EN
Clinical trial NCT00964678: Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Official title: Pilot Study of the Safety and Efficacy of Carvedilol in Pulmonary Arterial Hypertension
Conditions: Pulmonary Arterial Hypertension
Summary: The purpose of this study is to determine whether carvedilol treatment of patients with pulmonary arterial hypertension and associated right heart failure is safe and results in an improved function of the right heart.
Interventions:
description: twice daily oral treatment in escalating dose
name: Carvedilol
other_name: Coreg
type: Drug
Study arms:
design_group_description: Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
design_group_title: carvedilol
design_group_type: Experimental
Sponsor: Virginia Commonwealth University
Collaborators: GSK Plc
Drug name mappings:
name: 卡维地洛
lang: CN
name: Carvedilol
lang: EN
name: カルベジロール
lang: JP
Clinical trial NCT01689870: Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma
Official title: Phase 1/2 Study of the Combination of a Mouse Monoclonal Antibody to OX40 and Ipilimumab in Patients With Metastatic Melanoma
Conditions: Metastatic Melanoma
Summary: This is an open label, two-phase study combining a dose escalation Phase 1 with a proof-of-concept Phase 2 in patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated.
The purpose of the Phase 1 is to determine the Anti-OX40 Maximum Tolerated Dose (MTD) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and the tumor response assessed by the Immune-related Response Criteria.
The purpose of Phase 2 is to determine tumor response (by irRC) and the secondary objectives are anti-OX40 pharmacokinetics, biological activity and Safety/Tolerability.
Interventions:
description: Anti-OX40 will be administered i.v. over 60 minutes only in the first week on Days 1, 3 and 5
name: Anti-OX40
other_name: CD134 mab
type: Drug
description: Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1
name: Ipilimumab
other_name: YERVOY
type: Drug
Study arms:
design_group_description: Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered at 0.1 mg/kg over 60 minutes only in the first week on Days 1, 3 and 5.
design_group_title: Phase 1 Cohort 1
design_group_type: Experimental
design_group_description: Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered at 0.2 mg/kg over 60 minutes only in the first week on Days 1, 3 and 5.
design_group_title: Phase 1 Cohort 2
design_group_type: Experimental
design_group_description: Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered at 0.4 mg/kg over 60 minutes only in the first week on Days 1, 3 and 5.
design_group_title: Phase 1 Cohort 3
design_group_type: Experimental
design_group_description: Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1. Anti-OX40 will be administered i.v. at the Phase 1 Maximum Tolerated Dose over 60 minutes only in the first week on Days 1, 3 and 5.
design_group_title: Phase 2 Cohort 4
design_group_type: Experimental
Sponsor: Ludwig Institute for Cancer Research Ltd.
Collaborators: AgonOx LLC
Drug name mappings:
name: 伊匹木单抗
lang: CN
name: Ipilimumab
lang: EN
name: イピリムマブ（遺伝子組換え）
lang: JP
Clinical trial NCT03299413: Use of Mesenchymal Stem Cells in Inflammatory Bowel Disease
Official title: Ulcerative Colitis Stem Cell Therapy
Conditions: Inflammatory Bowel Diseases
Summary: Scientists hypothesize that directly or parentally injecting Mesenchymal stem cells (MSCs) to affected areas will have a positive impact through reducing or abolishing intestinal inflammation in part via inhibition of neutrophil Myeloperoxidase (MPOx) activity. Inhibiting MPOx should modify disease progression as well as reduce colitis associated cancer risk.
Interventions:
description: Wharton Jelly Mesenchymal stem cells will be injected intravenously
name: Wharton Jelly Mesenchymal stem cells
type: Biological
Study arms:
design_group_description: Wharton Jelly Mesenchymal stem cells will be given as a cell suspension in aseptic buffered solution in disposable vials with no preservative agents. The cells will be injected every two weeks at a total of three doses, 120 million cells in 10mls divided on two IV boli for each dose
design_group_title: Wharton Jelly Mesenchymal stem cells
design_group_type: Experimental
Sponsor: The University of Jordan
Collaborators: Scientific Research Projects
Drug name mappings:
name: Wharton jelly mesenchymal stem cells (University of Jordan)
lang: EN
Clinical trial NCT02004275: Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma
Official title: A Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib vs. Pomalidomide and Dexamethasone for Patients With Multiple Myeloma Relapsing on Lenalidomide as Part of First Line Therapy
Conditions: Multiple Myeloma in Relapse
Summary: This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.
Interventions:
description: given PO
name: pomalidomide
other_name: Pomalyst®
type: Drug
description: given PO
name: ixazomib
other_name: MLN9708
type: Drug
description: given PO
name: dexamethasone
type: Drug
Study arms:
design_group_description: Patients receive pomalidomide PO QD on days 1-21 and dexamethasone PO QD on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving disease progression may cross over to Arm II.
design_group_title: Arm I (pomalidomide, dexamethasone)
design_group_type: Experimental
design_group_description: Patients receive pomalidomide, dexamethasone, and ixazomib as in Phase I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
design_group_title: Arm II (pomalidomide, dexamethasone, ixazomib)
design_group_type: Experimental
Sponsor: Alliance Foundation Trials LLC
Collaborators: National Cancer Institute
Millennium Pharmaceuticals, Inc.
Celgene Corp.
Drug name mappings:
name: 枸橼酸伊沙佐米
lang: CN
name: Ixazomib citrate
lang: EN
name: イキサゾミブクエン酸エステル
lang: JP
name: 泊马度胺
lang: CN
name: Pomalidomide
lang: EN
name: ポマリドミド
lang: JP
name: 地塞米松
lang: CN
name: Dexamethasone
lang: EN
name: デキサメタゾン
lang: JP
Clinical trial NCT04446897: Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction
Official title: Treatment of Chronic Medium-severe Periodontitis With Mesenchymal Stem Cells Predifferentiated in Osteogenic Direction Immobilised on a Biodegradable Carrier
Conditions: Periodontitis, Chronic
Summary: Treatment of chronic medium-severe periodontitis with mesenchymal stem cells and mesenchymal stem cells predifferentiated in osteogenic direction
Interventions:
description: autologous mesenchymal stem cells
name: mesenchymal stem cells
type: Biological
description: standard treatment according to clinical protocols
name: standard treatment
type: Other
Study arms:
design_group_description: standard treatment according to clinical protocols plus mesenchymal stem cells
design_group_title: mesenchymal stem cells
design_group_type: Experimental
design_group_description: standard treatment according to clinical protocols
design_group_title: standard treatment
design_group_type: Active Comparator
Sponsor: The National Academy of Sciences of Belarus
Collaborators: Belarusian Medical Academy of Post Graduate Education
Drug name mappings:
name: Mesenchymal Stem Cells(Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus)
lang: EN
Clinical trial NCT04589832: Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
Official title: Phase 1B/2 Study of PAC-1 and Entrectinib for Patients With Metastatic Uveal Melanoma
Conditions: Uveal Melanoma
Summary: Single arm study with dose escalation Phase Ib cohort followed by a Phase II cohort. PAC-1 (PO) will be given daily on Days 1 through 21 of each cycle (28-day cycle). Entrectinib (PO) will be given daily on Days 1 through 28 of each cycle. Response will be evaluated after every 2 cycles. Treatment will continue until disease progression based on RECIST criteria or intolerable toxicity.
Interventions:
description: Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
name: PAC-1
type: Drug
description: Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
name: Entrectinib
type: Drug
Study arms:
design_group_description: Phase 1b will determine the MTD of PAC-1 in combination with entrectinib. Study treatment will include: PAC-1 will be taken orally on Days 1-21 and Entrectinib will be taken orally on Days 1-28 of each 28-day cycle. Treatment will continue until disease progression (based on RECIST 1.1 criteria), unacceptable toxicity, subject withdrawal of informed consent, or subject death either from progression of disease, the therapy itself, or from other causes.
design_group_title: Study Treatment Arm
design_group_type: Experimental
Sponsor: Hoosier Cancer Research Network
Collaborators: Genentech, Inc.
Vanquish Oncology, Inc.
Drug name mappings:
name: PAC-1
lang: EN
name: 恩曲替尼
lang: CN
name: Entrectinib
lang: EN
name: エヌトレクチニブ
lang: JP
Clinical trial NCT06885281: A Study of ZL-1310 in Participants With Selected Solid Tumors
Official title: A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Conditions: Solid Tumors
Summary: A Phase 1b/2, Open-label, Multi-center Study of ZL-1310 in Participants With Selected Solid Tumors
Interventions:
description: drug ZL-1310
name: ZL-1310
type: Drug
Study arms:
design_group_description: ZL-1310 as a single agent
design_group_title: Single Arm
design_group_type: Experimental
Sponsor: Zai Lab (Shanghai) Co., Ltd.
Collaborators: Zai Lab Ltd. (United States)
Drug name mappings:
name: Zocilurtatug Pelitecan
lang: EN
Clinical trial NCT05180422: A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis
Official title: A Phase I/II Study of AMG 510 in Combination With MVASI in Patients With Advanced, Unresectable or Metastatic KRAS G12C Mutant NSCLC With Asymptomatic Brain Metastasis.
Conditions: Non Small Cell Lung Cancer
Summary: This is a multicenter, non-randomized, open-label, phase I/II study to evaluate the safety and tolerability of AMG 510 plus MVASI in subjects with advanced KRAS p.G12C mutant non-small cell lung cancer (NSCLC) with small, untreated brain metastases.
Interventions:
description: Continuous once daily (QD) oral dosing (Days 1-21 each cycle) with or without food.
name: AMG 510
type: Drug
description: Intravenous (i.v.) infusion every 21 days (i.e. Day 1 of each 21-day cycle).
name: MVASI
type: Drug
Study arms:
design_group_description: AMG 510/MVASI
design_group_title: Dose Expansion
design_group_type: Experimental
Sponsor: CRITERIUM, Inc.
Collaborators: Amgen, Inc.
Drug name mappings:
name: 贝伐珠单抗生物类似药（安进）
lang: CN
name: Bevacizumab-awwb
lang: EN
name: ベバシズマブ（遺伝子組換え）
lang: JP
name: 索托拉西布
lang: CN
name: Sotorasib
lang: EN
name: ソトラシブ
lang: JP
Clinical trial NCT05827835: CD7 CAR-T Bridging to alloHSCT for R/R CD7+Malignant Hematologic Diseases
Official title: A Study to Evaluate the Efficacy and Safety of CD7CAR-T Bridging to Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Refractory or Relapsed CD7 Positive Malignant Hematologic Diseases
Conditions: Hematologic Diseases
Neoplasms
Summary: This is a single-arm, open-label, single-center, phase I/II study. The primary objective is to evaluate the safety of CD7 CAR-T Bridging to allo-HSCT therapy for patients with CD7-positive relapsed or refractory Malignant Hematologic Diseases
Interventions:
description: CD7 CAR T cells treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
name: CD7 CAR-T cells injection
type: Drug
description: In this study, Allogeneic hematopoietic stem cell transplantation is used as a bridge therapy to CD7 CAR T cells infusion to treat patients with refractory or relapsed CD7 positive Malignant Hematologic Diseases
name: Allogeneic hematopoietic stem cell transplantation
type: Other
Study arms:
design_group_description: R/R CD7+Malignant Hematologic Diseases
design_group_title: Treatment Group
design_group_type: Experimental
Sponsor: Zhejiang University
Collaborators: Shanghai Yake Biotechnology Co., Ltd
Drug name mappings:
name: Anti-CD7 CAR-T cell therapy  (Yake Biotechnology)
lang: EN
Clinical trial NCT06706050: Clinical Therapeutic Potential of Novel Microbiome LP-51 on Xerosis Individual Based on Xerosis-microbiome Index
Official title: Clinical Evaluation of Lactobarriome 5% Cream's Efficacy on Dry Skin for Improving Skin Hydration and Transepidermal Water Loss, Relieving Pruritus, and Altering the Skin Microbiome
Conditions: Xerosis
Summary: The purpose of this clinical trial is to assess the skin hydration and transepidermal water loss improvement, pruritus relief, and microbiome alteration effects of a Lactobacillus sp. product (Lactobarriome 5% cream) compared to a placebo cream to prove the skin improvement effects of Lactobarriome 5%, which is a nature-friendly material derived from intravaginal microflora that can replace chemical components commonly used as ingredients for existing cosmetics.
The impact of Lactobarriome 5% cream, formulated with LP51 culture filtrate, on dry skin was assessed through a 4-week double-blind clinical trial. Participants were selected based on predefined inclusion and exclusion criteria. Using a simple randomization method, participants were assigned to either the experimental group (receiving the test formulation) or the control group (receiving a placebo). The products were applied twice daily-morning and evening-to a 3 cm area on both the proximal and distal sides of the designated arm's crook. Clinical evaluations were conducted at baseline, as well as after 2 weeks and 4 weeks of product use. These assessments included visual inspections, subjective pruritus evaluations, skin hydration levels, and transepidermal water loss (TEWL) measurements, all performed by a skincare professional. Furthermore, magnified images were captured using a Folliscope, and skin samples were collected to analyze microbial changes post-treatment. Before application, the designated arm was washed with water and allowed to rest for 30 minutes under controlled conditions (22±2°C, 50±10% relative humidity).
Interventions:
description: Microbiome therapeutics LP-51 was applied on the individuals suffering from xerosis
name: Microbiome Therapeutic LP-51
type: Biological
description: placebo cream (M23004-03) was applied on the participants
name: placebo cream (M23004-03)
type: Other
Study arms:
design_group_description: test substance was applied on participants
design_group_title: Arm 1: LP-51
design_group_type: Experimental
design_group_description: cream without active substance (M23004-03) was applied on the participants
design_group_title: Arm 2: Placebo
design_group_type: Placebo Comparator
Sponsor: Soon Chun Hyang University
Collaborators: National Research Foundation of Korea
Soon Chun Hyang University
Drug name mappings:
name: Lactobarriome 5% Cream
lang: EN
Clinical trial NCT02843815: Combination of Cryosurgery and NK Immunotherapy for Advanced Non-Small Cell Lung Cancer
Conditions: Non-small Cell Lung Cancer Metastatic
Summary: The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced NSCLC.
Interventions:
description: Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
name: Cryosurgery
type: Device
description: Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
name: NK Immunotherapy
type: Biological
Study arms:
design_group_description: In this group, the patients will receive comprehensive cryosurgery first to destroy all big tumors, then receive multiple NK immunotherapy (intensive treatment: 6 times in first 3 months; then interval treatment: once every 3 months). The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).
design_group_title: Cryosurgery and NK immunotherapy
design_group_type: Experimental
design_group_description: In this group, the patients will receive comprehensive cryosurgery to destroy all big tumors. The check indexes are CT scan and blood tests (including tumor markers, lymphocyte subsets, circulating tumor cell).
design_group_title: Cryosurgery
design_group_type: Active Comparator
Sponsor: Fudan University Cancer Hospital
Collaborators: Shenzhen Hanke Bioengineering Co., Ltd.
Drug name mappings:
name: NK cell therapy (Shenzhen Hank Bioengineering Institute)
lang: EN