Clinical trials: Phase I
Lymphoma, Non-Hodgkin, Lymphoma, T-Cell
Phase Ⅰ Clinical Study of Anti-CD52 Monoclonal Antibody in NHL and T-PLL
Phase I clinical study of multicenter, single-arm, open, non-randomized evaluation of recombinant humanized anti-CD52 monoclonal antibody in the NHL and T-PLL
- Trial name
- NCT05557903
- Testing
- Recombinant Humanized Anti-CD52 Monoclonal Antibody Injection
- Where
- China
- Volunteers
- 71 people
- Sponsor
- Lanzhou Institute of Biological Products Co., Ltd
B-cell Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma
A Study of AZD0486 in Subjects With B-Cell Non-Hodgkin Lymphoma
This phase 1 study will investigate the safety, tolerability, pharmacokinetic, pharmacodynamic, and clinical activity of AZD0486, a CD19 x CD3 T-cell engaging bispecific antibody, in subjects with B-cell non-Hodgkin lymphoma…
- Conditions
- B-cell Non Hodgkin Lymphoma, Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma, Follicular Lymphoma
- Trial name
- NCT04594642
- Testing
- AZD0486 IV
- Where
- 25 sites in United States, Australia and 3 more
- Volunteers
- 226 people
- Sponsor
- AstraZeneca
Healthy
Study to Evaluate Safety, Tolerability, PK and PD of ALXN1007 in Healthy Subjects
The purpose of the study is to evaluate the safety, tolerability, PK and PD of a single-dose of ALXN1007 in healthy volunteers.
- Trial name
- NCT01454986
- Testing
- ALXN1007
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Bronchopulmonary Dysplasia
Safety and Efficacy of MSC-EVs in the Prevention of BPD in Extremely Preterm Infants
The phase 1/2 trial aims to evaluate the safety and efficacy of EXOB-001 consisting of extracellular vesicles derived from umbilical cord mesenchymal stromal cells in the prevention of bronchopulmonary dysplasia (BPD) in…
- Trial name
- EVENEW (NCT06279741)
- Testing
- Endotracheopulmonary Instillation, Suspension
- Where
- 8 sites in Belgium, Italy
- Volunteers
- 265 people
- Sponsor
- EXO Biologics S.A.
Hepatocellular Carcinoma (HCC)
Sequential T and I With H101 Via HAI for BCLC C Stage HCC: A Prospective Single-Center Single-Arm Pilot Study
Indication: Hepatocellular carcinoma (HCC) patients at Barcelona Clinic Liver Cancer (BCLC) stage C. Study Objectives: This study aims to use a prospective single-center single-arm pilot approach to preliminarily obtain data on…
- Trial name
- NCT06685354
- Testing
- hepatic arterial infusion of recombinant human type 5 adenovirus
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Henan Cancer Hospital
SARS-CoV-2 Infection
SARS-CoV-2-Neutralizing Monoclonal COVID-19 Antibody DZIF-10c by Inhalation
This is the first-in-human phase 1/2a trial of the inhaled administration of the SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c in healthy volunteers and SARS-CoV-2-infected individuals.
- Trial name
- NCT04631705
- Testing
- DZIF-10c
- Where
- 6 sites in Germany
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Cologne
IL-2 Induced Hypotension
Evaluation of M40403 for the Prevention of Dose Limiting Toxicities of High Dose IL-2
The clinical use of IL-2 is currently limited by development of dose-dependent hypotension (systolic blood pressure (SBP) < 90 mm Hg).
- Trial name
- NCT00033956
- Testing
- M40403
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- MetaPhore Pharmaceuticals
Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-248
This is a First in Human (FIH), double-blinded, parallel-group, randomised, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of GS-248 in healthy…
- Trial name
- NCT04036227
- Testing
- GS-248
- Where
- Sweden
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Gesynta Pharma AB
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
- Trial name
- NCT04091061
- Testing
- PF-06865571 100 mg
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Brain Stem Neoplasms, Glioma
A Phase I Study of IMC-A12 in Combination With Temsirolimus in Pediatric Patients With Recurrent or Refractory Solid Tumors
Background: IMC-A12 is an experimental substance designed to inhibit a protein called Type I Insulin-Like Growth Factor Receptor (IGF-1R), which can be found on cancer cells and can promote cancer growth.
- Conditions
- Brain Stem Neoplasms, Glioma, Pinealoma
- Trial name
- NCT01182883
- Testing
- IMC-A12, Temsirolimus
- Sponsor
- National Cancer Institute (NCI)
Non-Hodgkin's Lymphoma
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199
This is an open-label multicenter, study to assess the pharmacokinetic interaction of ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.
- Trial name
- NCT01969669
- Testing
- ABT-199, Ketoconazole
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- AbbVie
Locally Advanced or Metastatic Solid Tumor
AZD5305 hADME in Patients With Advanced Solid Malignancies
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of [14C]-Saruparib in patients with advanced solid malignancies.
- Trial name
- AZD5305 (NCT06713369)
- Testing
- Saruparib (AZD5305), [14C]-AZD5305 microtracer, [14C]-AZD5305 (therapeutic dose)
- Where
- 2 sites in United Kingdom
- Volunteers
- 8 people
- Sponsor
- AstraZeneca
Healthy Volunteers
Lung Deposition Via Different Inhalation Devices
The purpose of this study is to assess the deposition of budesonide to the lung after inhalation with 5 different devices and to relate the findings to in vitro properties of inhaled budesonide.
- Trial name
- NCT00975754
- Testing
- Pulmicort pMDI HFA, Budesonide pMDI HFA, Pulmicort Repulses
- Where
- Sweden
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Relative Bioavailability and Bioequivalence Study of Varegacestat in Healthy Participants
This is an open-label, randomized, crossover study to evaluate the relative bioavailability (rBA) and bioequivalence (BE) of a test capsule formulation of varegacestat compared to reference capsules formulation under fasting…
- Trial name
- NCT07610005
- Testing
- Varegacestat Reference Formulation, Varegacestat Test Formulation A, Varegacestat Test Formulation B
- Where
- United States
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Immunome, Inc.
Healthy Participants
A Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JZP441 in Healthy Participants
Treatments for narcolepsy and hypersomnolence disorders should have good oral bioavailability and brain penetration properties. JZP441 has demonstrated wake-promoting efficacy and anticataplectic activity in nonclinical studies…
- Trial name
- NCT05720494
- Testing
- JZP441
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jazz Pharmaceuticals
Primary Sjögren's Syndrome (pSS)
JH013 Injection in Patients With Primary Sjögren's Syndrome
This is a multicenter, open-label, single-arm Phase I study consisting of two parts: Part A, a single-dose dose-escalation phase, and Part B, a multiple-dose dose-escalation phase.
- Trial name
- NCT07818694
- Testing
- JH013 injection
- Volunteers
- 54 people
- Sponsor
- Biotech Pharmaceutical Co., Ltd.
Sarcoma, Soft Tissue Sarcoma
Cathepsin Activatable Fluorescent Probe
Real-time detection of cancer cells during surgical removal of a tumor is important. Currently when tissue is removed at the time of surgery, the removed tissue goes to pathology when the margins (edges of the tissue) are…
- Conditions
- Sarcoma, Soft Tissue Sarcoma, Breast Cancer
- Trial name
- LUM015 (NCT01626066)
- Testing
- LUM015
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- David Kirsch
Non Small Cell Lung Cancer
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
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…
- Trial name
- NCT05180422
- Testing
- AMG 510, MVASI
- Where
- United States
- Sponsor
- Criterium, Inc.
Sanfilippo Syndrome B
Intracerebral Gene Therapy in Children With Sanfilippo Type B Syndrome
This is an open-label, phase I/II study of intra-cerebral administration of adenovirus-associated viral vector containing the human NAGLU cDNA to children suffering from Sanfilippo type B syndrome.
- Trial name
- NCT03300453
- Testing
- rAAV2/5-hNAGLU
- Where
- France
- Volunteers
- 4 people
- Sponsor
- UniQure Biopharma B.V.
Allogeneic Transplantation (Non T-cell Depleted)
Phase I Clinical Trial to Assess Safety of UV Phototherapy for the Prevention of GVHD Post Allogeneic SCT
The primary goal of thos study is to assess safety of Ultraviolet (UV) Phototherapy for the Prevention of Graft versus Host Disease after allogeneic stem cell transplantation (Phase I - Clinical trial).
- Trial name
- NCT00524953
- Testing
- EUMATRON - EN 600 NT
- Where
- Israel
- Sponsor
- Hadassah Medical Organization
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