Clinical trials: Phase I
Solid Tumor, Advanced Cancer
Study of TJ033721 (Givastomig) in Subjects With Advanced or Metastatic Solid Tumors
This is an open label, multi-center, multiple dose Phase 1 study to evaluate the safety, tolerability, MTD PK, and PD of TJ033721 (givastomig) in subjects with advanced or metastatic solid tumors.
- Conditions
- Solid Tumor, Advanced Cancer, Metastatic Cancer, Gastric Cancer
- Trial name
- NCT04900818
- Testing
- TJ033721 (givastomig), TJ033721 (givastomig) , nivolumab, chemotherapy, TJ033721 (givastomig), chemotherapy
- Where
- 21 sites in United States, China
- Volunteers
- 330 people
- Sponsor
- I-Mab Biopharma US Limited
Colorectal Neoplasms
Study to Determine Safety, Pharmacokinetics, Pharmacodynamics of BAY73-4506 in Combination With mFOLFOX6 or FOLFIRI
This multi-center, open-label, non-randomized, non-placebo-controlled, Phase I study will define the safety profile and tumor response profile of the multi-kinase inhibitor BAY73-4506 as oral treatment in combination with the…
- Trial name
- NCT00934882
- Testing
- Regorafenib (BAY73-4506)
- Where
- 7 sites in Germany
- Volunteers
- 45 people
- Sponsor
- Bayer
Relapsed and/or Relapsed-refractory Multiple Myeloma
Safety and Efficacy of Melflufen and Dexamethasone in Relapsed and/or Relapsed-Refractory Multiple Myeloma Patients
The study will explore escalating doses of melflufen in combination with dexamethasone in small groups of patients to find the maximum tolerated dose of melflufen.
- Trial name
- NCT01897714
- Testing
- Melflufen, Dexamethasone
- Where
- 7 sites in United States, Denmark and 3 more
- Volunteers
- 75 people
- Sponsor
- Oncopeptides AB
Advanced Solid Tumors
Study With Atu027 in Patients With Advanced Solid Cancer
This is a phase I, prospective, open-label, single center, dose finding study with Atu027 (an siRNA formulation) given as single treatment followed by repeated treatment (repeated treatment phase: 8 treatments within 4 weeks) as…
- Trial name
- NCT00938574
- Testing
- Atu027
- Where
- Germany
- Volunteers
- 34 people
- Sponsor
- Silence Therapeutics GmbH
Gastric Cancer, Bladder Cancer
Safety, Tolerability and Pharmacokinetics of Oral CPL304110, in Adult Subjects With Advanced Solid Malignancies
The purpose of the study is to determine to evaluate safety and tolerability of CPL304110 when administered once daily to adults with advanced solid malignancies.
- Conditions
- Gastric Cancer, Bladder Cancer, Squamous Non-small Cell Lung Cancer, Cholangiocarcinoma
- Trial name
- NCT04149691
- Testing
- CPL304110
- Where
- 7 sites in Poland
- Volunteers
- 37 people
- Sponsor
- Celon Pharma SA
Health Participants
A Study to Assess Safety, Tolerability and Pharmacokinetics of Transdermal SFG-02 in Healthy Participants
This Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of a novel transdermal formulation of SFG-02 following single and repeated applications in Japanese and White healthy adult participants.
- Trial name
- NCT07167914
- Testing
- SFG-02
- Where
- Japan
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Juro Sciences Inc.
Healthy
Study of Radiolabeled Danicopan in Healthy Male Participants
This was an open-label study to evaluate the absorption, distribution, metabolism, and excretion of radioactivity in healthy male participants following a single 150-milligram (mg) oral dose of carbon-14 ([14C])-ACH-014447…
- Trial name
- NCT04889391
- Testing
- [14C]-Danicopan
- Where
- New Zealand
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Alexion Pharmaceuticals, Inc.
Non-Muscle-Invasive Bladder Cancer (NMIBC)
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SIM0237 Alone or in Combination with BCG in NMIBC
This is an open-label, multicenter phase 1 study to evaluate the safety, efficacy, and pharmacokinetics (PK) characteristics of SIM0237 alone or in combination with bacillus Calmette-Guerin (BCG) in participants with…
- Trial name
- NCT06186414
- Testing
- SIM0237, SIM0237 and BCG
- Where
- 14 sites in China
- Volunteers
- 152 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Breast Cancer
Safety Study of VM206RY in Subjects With Expression of HER2 in Breast Cancer
The main objective of this study is to evaluate the safety of VM206RY in subjects with expression of HER2 in breast cancer.
- Trial name
- VM206RY (NCT01895491)
- Testing
- VM206DNA, VM206Ad
- Where
- South Korea
- Volunteers
- 9 people
- Sponsor
- Reyon Pharmaceutical Co., Ltd.
Hypertrophic Cardiomyopathy
A Trial of HRS-1893 in Healthy Volunteers
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Trial name
- NCT07033455
- Testing
- HRS-1893
- Where
- Australia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
NHL, Multiple Myeloma
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers
This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without…
- Conditions
- NHL, Multiple Myeloma, Blood Cancer, Refractory Non-Hodgkin Lymphoma
- Trial name
- NCT06119685
- Testing
- IDP-023, Rituximab, Daratumumab
- Where
- 12 sites in United States
- Volunteers
- 128 people
- Sponsor
- Indapta Therapeutics, INC.
Pneumococcal Infection
A Phase I Study to Evaluate the Safety and Immunogenicity of PnuBioVax
Streptococcus pneumoniae is a type of bacteria that can cause infections of the ears, sinuses or lungs. It can also cause more serious infections of the blood or brain.
- Trial name
- NCT02572635
- Testing
- PnuBioVax
- Where
- United Kingdom
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- ImmunoBiology Limited
Metastatic Renal Cell Carcinoma
A Clinical Study to Evaluate Safety and Immunologic Response of COMBIG-DC, in Patients With Metastatic Kidney Cancer
The primary objective of this study is to answer the question "Is it possible to inject the Combig-DC vaccine in a renal tumour without getting unacceptable side effects"? Patients newly diagnosed with metastatic renal cell…
- Trial name
- NCT01525017
- Testing
- Combig-DC (allogeneic dendritic cells) Cancer Vaccine
- Where
- Sweden
- Volunteers
- 12 people
- Sponsor
- Mendus
Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Single + Multiple Ascending Dose and Food Effect Study of AZD7986 in Healthy Volunteers, PK, PD and Safety Study
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers
- Trial name
- NCT02303574
- Testing
- AZD7986, oral solution, 1 to 50 mg/mL
- Where
- United Kingdom
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Healthy
A Study of the Hedgehog Pathway Inhibitor GDC-0449 in Healthy Female Subjects of Non-Childbearing Potential
This is an open-label, Phase I, single-center, single-dose administration study to determine the absolute bioavailability, clearance, and volume of distribution of GDC-0449 (Part A) and to determine the routes of excretion and…
- Trial name
- NCT00991718
- Testing
- GDC-0449 oral capsules (non-labeled), GDC-0449 IV injection (labeled), CDC-0449 oral suspension (labeled)
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Advanced Solid Tumor
Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients
This is an open-label study in advanced solid tumor patients to determine if entrectinib affects the pharmacokinetics of midazolam and any of its pharmacologically active metabolites.
- Trial name
- NCT03330990
- Testing
- Entrectinib, Midazolam Hydrochloride
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Hoffmann-La Roche
Advanced Solid Tumors, Relapsed/Refractory Lymphoma
A Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Alisertib in Participants With Advanced Solid Tumors or Relapsed/Refractory Lymphoma
This study will assess the effect of multi-dose administration of itraconazole on the single-dose pharmacokinetics (PK) of alisertib.
- Trial name
- NCT02259010
- Testing
- Alisertib, Itraconazole
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Healthy Volunteers
Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.
- Trial name
- NCT02107313
- Testing
- Fed Cohort PBT2, Fasted Cohort PBT2
- Where
- Australia
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Prana Biotechnology Limited
Hepatic Impairment
A Phase I Study to Investigate the Effect of Hepatic Impairment of AZD9550 and AZD6234
The purpose of this study is to examine the safety and tolerability of AZD6234 and AZD9550 in participants with hepatic impairment and participants with normal hepatic function.
- Trial name
- NCT07546760
- Testing
- AZD6234, AZD9550
- Where
- 4 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Advanced Solid Tumors
A Study to Evaluate the Tolerance, Efficacy and Pharmacokinetics of TQB3558 Tablets
This is a study to evaluate the maximum tolerated dose (MTD) , occurrence of all adverse events (AE) and serious adverse events (SAE) , pharmacokinetic parameters and antitumor effect of TQB3558 tablets in Chinese adult patients…
- Trial name
- NCT04408079
- Testing
- TQB3558
- Where
- China
- Volunteers
- 70 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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