Clinical trials: Phase I
Recurrent Non-small Cell Lung Cancer
IR-guided Ablation (IRGA) Combined With Stereotactic Ablative Radiation (SABR) for Large Lung Tumors
This phase I trial studies the side effects and best dose of stereotactic body radiation therapy when given together with ablation therapy in treating patients with non-small cell lung cancer or lung metastases.
- Trial name
- NCT01746810
- Testing
- Stereotactic body RT and IRGA
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- New Mexico Cancer Research Alliance
Solid Tumours
Open-label Study of Topotecan and Pazopanib in Advanced Solid Tumors
To determined what dose of topotecan can be safely given with daily pazopanib.
- Trial name
- NCT00732420
- Testing
- topotecan, pazopanib
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 68 people
- Sponsor
- GlaxoSmithKline
Influenza
Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.
- Trial name
- NCT02438423
- Testing
- Inactivated influenza vaccine
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Mark Prausnitz
Healthy
Single Ascending Oral Dose Phase I Study With Px-102
The purpose of this study is to assess the safety and tolerability of the FXR agonist Px-102 in healthy subjects after single oral dosing.
- Trial name
- NCT01998659
- Testing
- Px-102
- Where
- Germany
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Phenex Pharmaceuticals AG
Neoplasms
Dose Escalation Study of BI 2536 BS in Patients With Advanced Solid Tumours With Repeated Administration in Patients With Clinical Benefit
Primary: Maximum tolerated dose (MTD) Secondary: Determination of the pharmacokinetic profile of BI 2536. Assessment of safety and efficacy.
- Trial name
- NCT02211859
- Testing
- BI 2536
- Volunteers
- 70 people
- Sponsor
- Boehringer Ingelheim
Leukemia, Myeloid, Acute
A Phase 1, Open Label Study of Intravenous GSK3745417 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Determine RP2D & Schedule in Participants With Relapsed or Refractory Myeloid Malignancies Including AML and HR MDS
This is a Phase 1, open label, two-part study to determine recommended phase 2 dose (RP2D) and schedule of GSK3745417 administration in participants with relapsed/refractory AML or HR-MDS.
- Trial name
- NCT05424380
- Testing
- GSK3745417
- Where
- 10 sites in Canada, Germany and 3 more
- Volunteers
- 18 people
- Sponsor
- GlaxoSmithKline
Rectal Cancer
Capecitabine-based Chemoradiotherapy in Combination With the IL-1 Receptor Antagonist Anakinra for Rectal Cancer Patients
The ACO/ARO/AIO-21 investigator-driven, open-labeled, phase I drug re-purposing trial will assess whether the IL-1 receptor antagonist Anakinra can be safely combined with fluoropyrimidine-based chemoradiotherapy (CRT) in…
- Trial name
- ACO/ARO/AIO-21 (NCT04942626)
- Testing
- Kineret 100 MG in 0.67 ML Prefilled Syringe, Capecitabine, Radiotherapy
- Where
- Germany
- Volunteers
- 12 people
- Sponsor
- Goethe University
Healthy
A Safety Study of Orally Administered BPM31510 in Healthy Subjects
This is an open-label, Phase I study of the bioavailability and safety of BPM31510 in healthy subjects dosed 2 or 3 times daily for 4 days, after an initial cohort of 6 subjects receiving a single dose (pre-study cohort).
- Trial name
- NCT02486055
- Testing
- BPM31510 Oral Nanosuspension 4%
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- BPGbio
Schistosomiasis
A Phase I Study of the Safety, Reactogenicity, and Immunogenicity of Sm-TSP-2/Alhydrogel® With or Without GLA-AF for Intestinal Schistosomiasis in Healthy Adults
This is a Phase I, first-in-human study of a vaccine against S. mansoni infection.The study will recruit 72 healthy adult males and non-pregnant females from a single clinical center to test two formulations of Sm-TSP-2 vaccine…
- Trial name
- NCT02337855
- Testing
- Sm-TSP-2/Alhydrogel, Sm-TSP-2/Alhydrogel/GLA-AF
- Where
- United States
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Not Applicable - Healthy Adult Participants
Study of XmAb412 in Healthy Participants
This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants
- Trial name
- NCT07713485
- Testing
- XmAb412 Monoclonal Bispecific Antibody
- Where
- 2 sites in Australia
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- Xencor, Inc.
Healthy
A Study to Understand How the Study Medicine Called ARV-471 is Processed in Healthy Adults
The purpose of the study is to understand how the study medicine ARV-471 is processed in the body of healthy males and females who do not have the potential to have children.
- Trial name
- NCT05930925
- Testing
- [phenyl-14C]ARV-471, [oxoisoindolin-14C]ARV-471
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Multiple Myeloma in Relapse, Multiple Myeloma Progression
Tinostamustine Conditioning and Autologous Stem Cell
Phase 1 The primary objectives of Phase 1 of this study are to: Establish the safety, toxicity, and maximum tolerated dose (MTD) of the tinostamustine conditioning regimen.
- Conditions
- Multiple Myeloma in Relapse, Multiple Myeloma Progression, Multiple Myeloma With Failed Remission
- Trial name
- TITANIUM1 (NCT03687125)
- Testing
- Tinostamustine, Autologous Stem Cell Transplant (ASCT)
- Where
- 12 sites in United States, Norway and 1 more
- Volunteers
- 6 people
- Sponsor
- Mundipharma-EDO GmbH
Healthy
Study to Evaluate the Safety, Local and Systemic Tolerability, and Pharmacokinetics of Multiple-Dose Topical Administration of PF-07038124 in Japanese Healthy Participants
The purpose of this study is to evaluate the safety, tolerability, skin irritation potential, and PK of PF-07038124 in Japanese healthy adult participants.
- Trial name
- NCT04863417
- Testing
- PF-07038124 or vehicle
- Where
- Japan
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Uterine Cervical Neoplasms
First-in-human (FIH) Phase I Trial of BS-006 in Cervical Cancer
This is a two-stage phase I clinical trial with oncolytic viruses BS-006 in recurrent or metastasis cervical cancer patients who failed in second line treatment.
- Trial name
- CC-OV01 (NCT05393440)
- Testing
- BS-006
- Where
- China
- Volunteers
- 18 people
- Sponsor
- Zhongnan Hospital
Zika Virus
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in healthy adult subjects.
- Trial name
- NCT03014089
- Testing
- mRNA-1325
- Where
- 3 sites in United States
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Pulmonary Disease, Chronic Obstructive
A Phase 1 (Ph1), Single Dose (SD), GSK961081 Absorption, Distribution, Metabolism, and Excretion (ADME) Study in Healthy Subjects
Batefenterol (GSK961081) is a bifunctional bronchodilator that is being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD).
- Trial name
- NCT02663089
- Testing
- [14C]-GSK961081 solution for IV infusion, [14C]-GSK961081 oral solution, GSK961081 dry powder for inhalation
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Theravance Biopharma
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma
Belinostat in Combination With Azacitidine or Pralatrexate for the Treatment of Relapse or Refractory T-cell Lymphoma
This phase I trial tests the safety, side effects and best dose of azacitidine in combination with belinostat and how well the combination works in treating patients with follicular helper T cell lymphoma (TFH) that has come back…
- Conditions
- Recurrent Anaplastic Large Cell Lymphoma, Recurrent Enteropathy-Associated T-Cell Lymphoma, Recurrent Follicular Helper T-Cell Lymphoma, Recurrent Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
- Trial name
- NCT07691450
- Testing
- Azacitidine, Belinostat, Biospecimen Collection
- Where
- 2 sites in United States
- Volunteers
- 40 people
- Sponsor
- City of Hope Medical Center
Diabetes Mellitus Type 1
Use of Stem Cells in Diabetes Mellitus Type 1
Allogenic adipose derived mesenchymal stem cells will be injected into patients newly diagnosed with type 1 Diabetes Mellitus
- Trial name
- NCT02940418
- Testing
- Adipose mesenchymal cells with bone marrow mononuclear cells
- Where
- Jordan
- Volunteers
- 20 people
- Sponsor
- Sophia Al-Adwan
Advanced Solid Tumors
A First-in-Human (FIH) Study to Evaluate the Safety and Tolerability of VVD-159642 in Participants With Advanced Solid Tumors
A FIH study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of VVD-159642, a rat sarcoma viral oncogene-phosphatidylinositol 3-kinase alpha (RAS-PI3Kα)…
- Trial name
- NCT06804824
- Testing
- VVD-159642, Sotorasib, Trametinib
- Where
- 9 sites in United States, Australia
- Volunteers
- 220 people
- Sponsor
- Vividion Therapeutics, Inc.
Tuberculosis
A Phase I Study Investigating the Local Tolerability and Pharmacokinetics of Isoniazid (INH) Inhalation by Wet Nebulization in Patients With Tuberculosis
Rationale: To halt the global tuberculosis (TB) crisis, and particular the ongoing threat of drug-resistant TB (DR-TB), it is essential to reduce transmission.
- Trial name
- INHalation-01 (NCT07708779)
- Testing
- Isoniazid
- Where
- Netherlands
- Volunteers
- 8 people
- Sponsor
- University Medical Center Groningen
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