Clinical trials: Dose Escalation and Safety
Hepatitis C, Chronic
Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection
To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients
- Trial name
- VGX-6150-01 (NCT02027116)
- Testing
- VGX-6150
- Where
- 2 sites in South Korea
- Volunteers
- 18 people
- Sponsor
- GeneOne Life Science, Inc.
Refractory or Recurrent CD30+ Hematologic Malignancies
A Study of F0002-ADC in Chinese Patients With Refractory or Recurrent CD30+ Hematologic Malignancies.
This is a Phase I dose escalation study designed to define the maximum tolerable dose(MDT), the safety profile, pharmacokinetic parameters, immunogenicity and anti-tumor activity of F0002-ADC in Chinese patients with…
- Trial name
- NCT03894150
- Testing
- F0002-ADC
- Where
- 2 sites in China
- Volunteers
- 45 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Neoplasms
Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral ipatasertib (GDC-0068) administered in combination with either docetaxel (Arm A), or…
- Trial name
- NCT01362374
- Testing
- 5-FU, Docetaxel, Enzalutamide
- Where
- 11 sites in United States, France and 2 more
- Volunteers
- 122 people
- Sponsor
- Genentech, Inc.
Neoplasms
A Study of ADH 1 in Combination With Carboplatin, or Docetaxel or Capecitabine
N-cadherin, a protein involved in blood vessel cell binding, is increased as cancer progresses, and is on the surface of many tumor cells. ADH-1 blocks N-cadherin.
- Trial name
- NCT00390676
- Testing
- ADH -1 and carboplatin, ADH -1 and docetaxel, ADH -1 and capecitabine
- Where
- 10 sites in United States
- Sponsor
- Adherex Technologies, Inc.
Healthy Volunteers Pharmacokinetic Study
Dose-escalation Study to Assess Selumetinib Safety, Tolerability and PK
The purpose of the study is to assess the safety, tolerability and PK of selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) in healthy male Japanese and non-Japanese Asian volunteers following administration of a single dose.
- Trial name
- NCT01960374
- Testing
- Selumetinib
- Where
- United Kingdom
- Volunteers
- 117 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Typhoid
Immunogenicity, Safety and Tolerability of the Typhoid Fever Vaccine Candidate M01ZH09 in Healthy Adults
This study is to investigate the safety, tolerability and immunogenicity of the typhoid fever vaccine candidate M01ZH09 manufactured at commercial scale, at a new manufacturing facility.
- Trial name
- NCT00679172
- Testing
- Dose of 5.0 x 10^9 CFU (Cohort 1), Dose of 7.5 x 10^9 CFU (Cohort 2), Dose of 1.1 x 10^10 CFU (Cohort 3)
- Where
- 3 sites in United States
- Volunteers
- 187 people, healthy volunteers welcome
- Sponsor
- Emergent BioSolutions
Mild to Moderate Atopic Dermatitis
A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients
This study aims to evaluate the safety, tolerability and pharmacokinetic properties of IN-A002 Ointment in healthy adult male volunteers and mild to moderate atopic dermatitis patients
- Trial name
- NCT05729074
- Where
- South Korea
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- HK inno.N Corporation
Hepatitis b Virus, Hepatitis B
HepB mAb19 in Individuals With Chronic Hepatitis B Infection
This is a first-in-human, placebo-controlled, single dose, dose-escalation phase 1 study to evaluate the safety, pharmacokinetics and antiviral activity of a highly potent neutralizing anti-HBV monoclonal antibody (mAb), HepB…
- Trial name
- NCT05856890
- Testing
- HepB mAb19, Sterile Saline
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Rockefeller University
ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)
A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
This study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
- Trial name
- CYCAD-1 (NCT06188520)
- Testing
- AZD8421, Camizestrant, Ribociclib
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 55 people
- Sponsor
- AstraZeneca
Solid Tumors
MSX-122 Administered Orally in Patients With Refractory Metastatic or Locally Advanced Solid Tumors
Primary Objectives: 1. To determine the maximum tolerated dose (MTD) and the recommended Phase II dose(s) and schedule of MSX-122 2.
- Trial name
- NCT00591682
- Testing
- MSX-122
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Metastatix, Inc.
Brain Injuries, Traumatic
Safety Study of NNZ-2566 in Healthy Female Subjects
The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers.
- Trial name
- NCT00961779
- Testing
- NNZ-2566
- Where
- Australia
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Neuren Pharmaceuticals Limited
Non-muscle Invasive Bladder Cancer, NMIBC
A Phase 1 Dose-escalation Study of UGN-301 in Patients With Recurrent Non-muscle Invasive Bladder Cancer (NMIBC)
This study is being conducted to evaluate the safety and determine the recommended Phase 2 dose (RP2D) of UGN-301 (zalifrelimab) administered intravesically as monotherapy and in combination with other agents in patients with…
- Conditions
- Non-muscle Invasive Bladder Cancer, NMIBC, Carcinoma in Situ of Bladder, Bladder Cancer
- Trial name
- NCT05375903
- Testing
- UGN-301, UGN-201, Gemcitabine
- Where
- 13 sites in United States, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- UroGen Pharma Ltd.
Healthy Participants
Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, & Food Effect of Oral INCB000631 to Healthy Adult Participants
This study will be conducted to assess the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics, and Food Effect of INCB000631 When Administered Orally to Healthy Adult Participants.
- Trial name
- NCT06775327
- Testing
- INCB000631
- Where
- United States
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Incyte Corporation
Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
Study of Safety and Preliminary Efficacy for LDK378 in Japanese Patients With Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
Estimation of the Maximum tolerated dose (MTD) and/or Recommended dose (RD) of LDK378 as a single agent when administered orally to Japanese patients with tumors characterized by genetic alterations in anaplastic lymphoma kinase…
- Trial name
- NCT01634763
- Testing
- LDK378
- Where
- 3 sites in Japan
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Stargardt Disease
Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety of a Single Intravitreal Injection of RTx-021 in Patients With Stargardt Disease
A Phase 1/2, open-label, non-randomized, dose-escalation study, where a minimum of 9 and a maximum of 18 eligible patients with Stargardt Disease will be enrolled sequentially in up to 3 dose cohorts of RTx-021.
- Trial name
- AURORA (NCT07439887)
- Testing
- RTx-021
- Where
- 3 sites in United States
- Volunteers
- 18 people
- Sponsor
- Ray Therapeutics, Inc.
Advanced or Metastatic Solid Tumors
A Study of MRG004A in Patients With Tissue Factor Positive Advanced or Metastatic Solid Tumors
The objective of this study is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG004A in patients with Tissue Factor positive advanced or metastatic solid tumors.
- Trial name
- NCT04843709
- Testing
- MRG004A
- Where
- 9 sites in United States, China
- Volunteers
- 39 people
- Sponsor
- Lepu Biopharma Co., Ltd.
Squamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Carcinoma-Enrollment Completed
A Dose Escalation and Cohort Expansion Study of Anti-CD27 (Varlilumab) and Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors
This is a study to determine the clinical benefit (how well the drug works), safety, and tolerability of combining varlilumab and nivolumab (also known as Opdivo® , BMS-936558).
- Conditions
- Squamous Cell Carcinoma of the Head and Neck (SCCHN), Ovarian Carcinoma-Enrollment Completed, Colorectal Cancer (CRC)-Enrollment Completed, Renal Cell Carcinoma (RCC) (Phase ll Only)
- Trial name
- NCT02335918
- Testing
- Combination of varlilumab and nivolumab
- Where
- 19 sites in United States
- Volunteers
- 175 people
- Sponsor
- Celldex Therapeutics
Healthy Subject
Phase 1 Study of 3D229 in Healthy Subjects
This is a Phase 1 Study to Evaluate the Safety and tolerability of 3D-229 in health subjects
- Trial name
- NCT04941313
- Testing
- 3D229
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- 3D Medicines
Metastatic Pancreatic Cancer
A Study of Galunisertib (LY2157299) and Durvalumab (MEDI4736) in Participants With Metastatic Pancreatic Cancer
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as galunisertib administered in combination with the anti-programmed cell death-ligand 1 (PD-L1) antibody durvalumab in participants…
- Trial name
- NCT02734160
- Testing
- Galunisertib, Durvalumab
- Where
- 11 sites in United States, France and 3 more
- Volunteers
- 37 people
- Sponsor
- Eli Lilly and Company
Healthy
Dose-Escalate Study to Investigate the Safety and Tolerability of T89 in Japanese
The purpose of this study is to see how safe an investigational new drug (T89) is and how well healthy Japanese subjects tolerate it when given two single doses and a multiple dose.
- Trial name
- NCT01679028
- Testing
- T89 Group A, T89 Group B
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Tasly Pharmaceuticals, Inc.
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