Clinical trials: PH1
Influenza, Pandemic
A Safety and Immunogenicity of Intranasal Nanoemulsion Adjuvanted Recombinant Pandemic Flu Vaccine in Healthy Adults
The purpose of this clinical trial is to evaluate the safety and immunogenicity of BW-1014. BW-1014 is a nanoemulsion (NE) adjuvanted recombinant Hemagglutinin 5 (rH5) that would protect against pandemic flu.
- Trial name
- IN-NE-rH5 (NCT05397119)
- Testing
- BW-1014: 25 µg rH5 in 20% NE - pipette - IN, BW-1014: 50 µg rH5 in 20% NE - pipette - IN, BW-1014: 100 µg rH5 in 20% NE - pipette - IN
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- BlueWillow Biologics
Primary Hyperoxaluria Type 1
Proteomics of Primary Hyperoxaluria Type 1
The purpose of this study is to identify unique urine protein markers of Primary Hyperoxaluria type 1 (PH1) compared to healthy controls.
- Trial name
- PH1 (NCT03067142)
- Testing
- Observational
- Volunteers
- 93 people, healthy volunteers welcome
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
Cystic Fibrosis, Pseudomonas Aeruginosa
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis
Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered…
- Conditions
- Cystic Fibrosis, Pseudomonas Aeruginosa, Pseudomonas, Lung Infection
- Trial name
- SWARM-Pa (NCT04596319)
- Testing
- AP-PA02
- Where
- 20 sites in United States
- Volunteers
- 29 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Carcinoma, Non-Small Cell Lung
PH 1 Evaluation Of Oral CI-1033 In Combination With Paclitaxel/ Carboplatin As 1st Line Chemotherapy In NSCLC Patients
The main purpose of this study is to evaluate the overall safety and maximum dose of CI 1033 in combination with paclitaxel and carboplatin in patients with NSCLC.
- Trial name
- NCT00174356
- Testing
- CI 1033, PACLITAXEL, CARBOPLATIN
- Where
- 7 sites in United States, Canada
- Volunteers
- 39 people
- Sponsor
- Pfizer
Primary Hyperoxaluria Type 1, PH1
Phase I Exploratory Study of YOLT-203 in Patients With Primary Hyperoxaluria Type 1 (PH1)
This is a single-arm, open-label, single-dose dose-escalation study. It aims to evaluate the safety and tolerability of YOLT-203 in Chinese patients with Primary Hyperoxaluria Type 1 (PH1), and to preliminarily assess the effect…
- Trial name
- NCT07776626
- Testing
- YOLT-203
- Where
- China
- Volunteers
- 9 people
- Sponsor
- YolTech Therapeutics Co., Ltd
Hepatocellular Carcinoma
Ph 1 Trial of ADI PEG 20 Plus Sorafenib to Treat Patients With Liver Cancer
Assessment of safety and tolerability of ADI-PEG 20 in combination with sorafenib in advanced Hepatocellular Carcinoma (HCC).
- Trial name
- NCT02101593
- Testing
- ADI-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 8 people
- Sponsor
- Polaris Group
Anemia in Myelodysplastic Syndromes
A Study of TP-0184 to Treat Anemia in Adults With IPSS-R Low or Intermediate Risk MDS
This study will evaluate preliminary safety and efficacy of TP-0184 to treat anemia when administered to adult patients with Revised International Prognostic Scoring System (IPSS-R) low or intermediate risk MDS.
- Trial name
- NCT04623996
- Testing
- TP-0184
- Where
- 3 sites in United States
- Volunteers
- 2 people
- Sponsor
- Sumitomo Pharma America, Inc.
Pre-exposure Prophylaxis Against Pneumonic Plague in Healthy Adults
Ph1, Randomized, Double-Blind and Controlled, Dose Escalation and Expansion Study to Assess the Safety and Pharmacokinetics of JST-010 in Healthy Adults
The goal of this clinical trial is to learn if a single dose of the study drug, JST-010, is safe and tolerable when administered by injection into the arm or thigh muscle of healthy men and women aged 18 to 55.
- Trial name
- NCT06943378
- Testing
- Monoclonal antibody JST-010
- Where
- United States
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Just-Evotec Biologics
AML/MDS
Study of Mana 312 (Multi Tumor-Associated Antigen T Cells) in Adults With AML/MDS After HSCT
This is a Phase 1, open-label, non-randomized, single and multiple dose escalation study designed to evaluate the safety and preliminary efficacy of administering Mana 312 to subjects with AML/MDS after allogeneic HSCT.
- Trial name
- NCT04679194
- Testing
- Mana 312
- Where
- 8 sites in United States
- Volunteers
- 11 people
- Sponsor
- Mana Therapeutics
Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2)
A Study to Evaluate DCR-PHXC in Children and Adults With Primary Hyperoxaluria Type 1 and Primary Hyperoxaluria Type 2
The purpose of this study is to evaluate the efficacy and safety of DCR-PHXC in Children and Adults with Primary Hyperoxaluria Type 1 (PH1) and Primary Hyperoxaluria Type 2 (PH2)
- Conditions
- Primary Hyperoxaluria Type 1 (PH1), Primary Hyperoxaluria Type 2 (PH2), Kidney Diseases, Urologic Diseases
- Trial name
- PHYOX2 (NCT03847909)
- Testing
- DCR-PHXC, Sterile Normal Saline (0.9% NaCl)
- Where
- 28 sites in United States, Australia and 13 more
- Volunteers
- 35 people
- Sponsor
- Novo Nordisk A/S
Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2
Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3
Evaluation of the efficacy and safety of stiripentol in patients 6 years and older with primary hyperoxaluria type 1, 2 or 3.
- Conditions
- Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2, Primary Hyperoxaluria Type 3
- Trial name
- CRYSTAL (NCT06465472)
- Testing
- Stiripentol Oral Capsule, Urine samples collect, Blood samples collect
- Volunteers
- 42 people
- Sponsor
- Biocodex
Solid Tumors, Triple-Negative Breast Cancer
Study of the Glutaminase Inhibitor CB-839 in Solid Tumors
Many tumor cells, in contrast to normal cells, have been shown to require the amino acid glutamine to produce energy for growth and survival.
- Conditions
- Solid Tumors, Triple-Negative Breast Cancer, Non Small Cell Lung Cancer, Renal Cell Carcinoma
- Trial name
- NCT02071862
- Testing
- CB-839, Pac-CB, CBE
- Where
- 13 sites in United States
- Volunteers
- 210 people
- Sponsor
- Calithera Biosciences, Inc
Hyperoxaluria (Disorder)
Oxalate Excretion Profile in Patients With a Heterozygous Mutation of the AGXT (Alanine-glyoxylate Aminotransferase) Gene
Primary hyperoxaluria type I (PH1) is a rare genetic disorder responsible for severe lithiasis leading to progressive deterioration of renal function and end-stage renal failure.
- Trial name
- HETEROX (NCT06283082)
- Testing
- Lithiasis assessment
- Where
- France
- Volunteers
- 25 people
- Sponsor
- Hospices Civils de Lyon
Non Small Cell Lung Cancer, Triple Negative Breast Cancer
CAB-ROR2-ADC Safety and Efficacy Study in Patients With TNBC or Head & Neck Cancer (Ph1) and NSCLC or Melanoma (Ph2)
The objective of this study is to assess safety and efficacy of CAB-ROR2-ADC in solid tumors
- Conditions
- Non Small Cell Lung Cancer, Triple Negative Breast Cancer, Melanoma, Head and Neck Cancer
- Trial name
- NCT03504488
- Testing
- CAB-ROR2-ADC, PD-1 inhibitor
- Where
- 59 sites in United States, Greece and 4 more
- Volunteers
- 132 people
- Sponsor
- BioAtla, Inc.
Ovarian Tumors
First-in-Human Evaluation of GRN-300 in Subjects With Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Cancers.
The study consists of two parts based on the administration of single-agent GRN-300 or in combination with paclitaxel. Part 1 (Phase IA) will test the tolerability of continuous twice a day dosing of oral GRN-300, a…
- Trial name
- NCT04711161
- Testing
- GRN-300, Paclitaxel
- Where
- United States
- Volunteers
- 73 people
- Sponsor
- Green3Bio, Inc.
Stomach Neoplasm
Trastuzumab Deruxtecan(T-DXd) and Afatinib Combination in HER2-low Advanced Gastric Cancer
Despite recent advances, the prognosis of patients with advanced gastric cancer remains poor. At present, regimens that combine a platinum and fluorouracil agent either alone or in combination with a third drug such as epirubicin…
- Trial name
- NCT06085755
- Testing
- Trastuzumab deruxtecan, Afatinib
- Where
- South Korea
- Volunteers
- 61 people
- Sponsor
- Jeeyun Lee
Solid Tumors, Prostate Cancer
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
This Phase I trial combines ADI-PEG 20 with docetaxel in patients with advanced solid tumors with emphasis on castration resistant prostate cancer (CRPC).
- Trial name
- NCT01497925
- Testing
- ADI-PEG 20
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- Polaris Group
Cocaine Addiction
Vigabatrin Ph 1 Cocaine Interaction Study
This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.
- Trial name
- NCT00626834
- Testing
- Vigabatrin
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- National Institute on Drug Abuse (NIDA)
Type 1 Primary Hyperoxaluria
Clinical Exploration Study of YOLT-203 in the Treatment of Type 1 Primary Hyperoxaluria (PH1)
This study is a single-arm, open-label, single-dose, dose-escalation trial, aiming to evaluate the safety and tolerability of YOLT-203 in the Chinese population with type 1 primary hyperoxaluria (PH1); and to preliminarily assess…
- Trial name
- PH1 (NCT06892301)
- Testing
- YOLT-203
- Where
- China
- Volunteers
- 2 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Relapsed or Refractory Multiple Myeloma
A Ph1/2 Study of EMB-06 in Participants With Relapsed or Refractory Myeloma
The primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-06 and to characterize the safety and tolerability of EMB-06 at the RP2Ds.
- Trial name
- NCT04735575
- Testing
- EMB-06
- Where
- 10 sites in Australia, China
- Volunteers
- 40 people
- Sponsor
- Shanghai EpimAb Biotherapeutics Co., Ltd.