Clinical trials: Phase 1
Healthy Volunteer, Hypersensitivity Reactions
Novel Biomarkers of Non-IgE Immediate Hypersensitivity Drug Reactions
The goal of this clinical trial is to investigate biomarkers of non-IgE-mediated immediate hypersensitivity reactions during infusion of intravenous vancomycin.
- Conditions
- Healthy Volunteer, Hypersensitivity Reactions, Vancomycin
- Trial name
- NCT07605806
- Testing
- Vancomycin (IV)
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Myeloproliferative Neoplasms (MPNs)
A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
This is a multi-center, open-label, Phase 1/1b study designed to evaluate the safety, pharmacokinetics, immunogenicity, and preliminary efficacy of DMR-001 monotherapy in adult participants with CALR-mutated essential…
- Trial name
- CLARITY-101 (NCT07849231)
- Testing
- DMR-001, Ruxolitinib
- Where
- 36 sites in United States, Australia
- Volunteers
- 250 people
- Sponsor
- Damora Therapeutics
B-cell Mediated Autoimmune Disorders
A Study to Assess the Safety and Clinical Activity of Azer-cel in Participants With B-cell Mediated Autoimmune Disorders
The main objective of the study is to determine the recommended phase 2 dose (RP2D) of Azercabtagene zapreleucel (azer-cel).
- Trial name
- NCT06680037
- Testing
- Azercabtagene zapreleucel (azer-cel)
- Where
- 8 sites in United States
- Volunteers
- 100 people
- Sponsor
- TG Therapeutics, Inc.
Vasomotor Symptoms Associated With Menopause, Healthy Volunteers
Study Evaluating ABCL635 for Vasomotor Symptoms of Menopause
The purpose of this study is to evaluate the effects of single and multiple doses of ABCL635 administered by subcutaneous (SC) injection to healthy men and to postmenopausal women with or without any vasomotor symptoms (VMS) or…
- Trial name
- NCT07118891
- Testing
- ABCL635
- Where
- 13 sites in Canada
- Volunteers
- 136 people, healthy volunteers welcome
- Sponsor
- AbCellera Biologics Inc.
Biliary Cancer, Bile Duct Cancer
A Study of CDX-1140, a CD40 Agonist, in Combination With Capecitabine and Oxaliplatin (CAPOX) and Keytruda in Subjects With Biliary Tract Carcinoma (BTC)
Background: Biliary tract carcinoma (BTC) is cancer of the slender tubes that carry fluids in the liver. People with advanced BTC have few treatment options, and their survival rates are very low.
- Conditions
- Biliary Cancer, Bile Duct Cancer, Cancer of the Bile Duct
- Trial name
- NCT05849480
- Testing
- oxaliplatin, capecitabine, Keytruda
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National Cancer Institute (NCI)
Healthy
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
The trial aims to study the safety, tolerability, and pharmacokinetics of single and multiple rising doses of BI 3776528.
- Trial name
- NCT06745297
- Testing
- BI 3776528, short-acting benzodiazepine
- Where
- Germany
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets
Evaluation of Safety, Tolerability, and Efficacy of INZ-701 in Adults With ENPP1 Deficiency
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses of INZ-701, an ectonucleotide pyrophosphatase/phosphodiesterase 1 (ENPP1) enzyme…
- Conditions
- Ectonucleotide Pyrophosphatase/phosphodiesterase1 Deficiency, Autosomal Recessive Hypophosphatemic Rickets, Generalized Arterial Calcification of Infancy
- Trial name
- NCT04686175
- Testing
- INZ-701
- Where
- 7 sites in United States, Canada and 3 more
- Volunteers
- 13 people
- Sponsor
- Inozyme Pharma
Colorectal Neoplasms, Neoplasms
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Background: Cancers that begin in the colon, adrenal glands, or bile ducts may spread to the liver. These liver tumors are often treated using a hepatic artery infusion (HAI) pump.
- Conditions
- Colorectal Neoplasms, Neoplasms, Intrahepatic Cholangiocarcinoma, Adrenocortical Carcinoma
- Trial name
- NCT07715903
- Testing
- Carfilzomib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- National Cancer Institute (NCI)
Renal Cell Carcinoma
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
The purpose of this study is to evaluate the efficacy and safety of belzutifan monotherapy and belzutifan plus palbociclib combination therapy in participants with advanced clear-cell renal cell carcinoma (ccRCC) who experienced…
- Trial name
- NCT05468697
- Testing
- Belzutifan, Palbociclib
- Where
- 13 sites in United States, Australia and 1 more
- Volunteers
- 60 people
- Sponsor
- Merck Sharp & Dohme LLC
Sickle Cell Disease
A Phase I/II Study of ITU512 in Healthy Participants and Patients With Sickle Cell Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary food effect of ITU512 as well as the fetal hemoglobin (HbF)-inducing capacity of ITU512.
- Trial name
- NCT06546670
- Testing
- ITU512
- Where
- 14 sites in United States, Brazil and 1 more
- Volunteers
- 161 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma
DAREON®-36: A Study to Test Obrixtamig in Combination With ZL-1310 in People With Advanced Small Cell Lung Cancer or Other Neuroendocrine Cancers
This study is open to adults with advanced small cell lung cancer and other neuroendocrine cancers. The study has 2 parts. The purpose of Part 1 is to find a suitable dose of a combination study treatment, obrixtamig and ZL-1310.
- Conditions
- Small Cell Lung Cancer, Large Cell Neuroendocrine Lung Carcinoma, Extrapulmonary Neuroendocrine Carcinoma of Small Cell Histology, Extrapulmonary Neuroendocrine Carcinoma of Large Cell Histology
- Trial name
- NCT07707895
- Testing
- Obrixtamig, ZL-1310, Atezolizumab
- Where
- 27 sites in United States, Australia and 9 more
- Volunteers
- 60 people
- Sponsor
- Boehringer Ingelheim
Clear Cell Renal Cell Carcinoma
A Phase 1 Trial of ADI-270 in ccRCC
This is a Phase 1 multicenter, open-label, dose escalation, and dose expansion study of ADI-270 - an Engineered gamma-delta Chimeric Receptor [CAR] Vδ1 T Cell product Targeting CD70 - in patients with R/R ccRCC.
- Trial name
- NCT06480565
- Testing
- ADI-270, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Adicet Therapeutics
Lung Cancer
Impact of Using a GLP1 on Treatment Related Side Effects of Lung Cancer Patients Receiving Lorlatinib
The proposed study seeks to address a critical gap in the management of lorlatinib-induced metabolic derangements, particularly rapid weight gain, which can adversely affect treatment adherence, dosing and ultimately patient…
- Trial name
- NSCLC (NCT07782359)
- Testing
- Tirzepatide
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Chicago
Advanced Solid Tumor (Phase 1)
A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of HSK46256 in Patients With Advanced Solid Tumors
This is a Phase 1, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of HSK46256 tablets, a selective PARP1 inhibitor, in patients with advanced solid tumors.
- Trial name
- NCT07695142
- Testing
- HSK46256
- Where
- China
- Volunteers
- 275 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Schizophrenia
Phase I Trial of HHK101 in Patients With Schizophrenia
This study aims to learn how the study drug is absorbed by the body, check for possible side effects, and see if the drug may help improve symptoms in patients with schizophrenia.
- Trial name
- NCT07815210
- Testing
- HHK101-Single Dose 1, HHK101-Single Dose 2, HHK101-Single Dose 3
- Volunteers
- 88 people
- Sponsor
- Zhuhai Huahaikang Pharmaceutical Technology Co., Ltd.
Brain (Nervous System) Cancers
Study of Disulfiram to Reduce Myeloid Immunosuppression and Steroid Dependence in Resectable High Grade Glioma
This research study is for participants with glioblastoma. It can cause a tumor immunosuppression which helps myeloid cells that can stop T-cell function.
- Trial name
- NCT07719127
- Testing
- Disulfiram (DSF)
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Case Comprehensive Cancer Center
Malignant Germ Cell Tumor, Lung Adenocarcinoma
DBC-664 in Adult Patients With Solid Tumors
DBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian…
- Conditions
- Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma, Urothelial Carcinoma
- Trial name
- NCT07705035
- Testing
- DBC-664
- Where
- 7 sites in United States
- Volunteers
- 210 people
- Sponsor
- Duboce Biopharmaceuticals, Inc.
Somatostatin Receptor Positive, NETs
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors
The purpose of the study is to determine the appropriate pediatric dosage and evaluate the pharmacokinetics (PK) and safety of Lutetium Lu 177 Edotreotide Targeted Radiopharmaceutical Therapy (RPT) as a monotherapy or following…
- Conditions
- Somatostatin Receptor Positive, NETs, Lymphoma, Solid Tumor
- Trial name
- KinLET (NCT06441331)
- Testing
- Lutetium Lu 177-Edotreotide, Amino Acid Solution
- Where
- 9 sites in United States, France and 1 more
- Volunteers
- 20 people
- Sponsor
- ITM Solucin GmbH
Healthy
A Clinical Trial of MK-1406 in Healthy Participants (MK-1406-008)
The purpose of this trial is to compare what happens to MK-1406 in the body of healthy participants when it is given as 2-injections and 3-injections.
- Trial name
- NCT07743151
- Testing
- MK-1406
- Where
- 7 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Alcohol Use Disorder
PET Imaging of Phosphodiesterase-4B (PDE4B) in Alcohol Use Disorder
Background: People with alcohol use disorder (AUD) also often have bouts of depression called major depressive episodes (MDEs). People having MDEs have been found to have low levels of a protein called PDE4B in the brain.
- Trial name
- NCT06795581
- Testing
- 18F-PF-06445974, Oxazepam
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Mental Health (NIMH)
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