Clinical trials: Dose Escalation and Safety
Healthy
Safety and Tolerability of SYNB1934 in Healthy Adult Volunteers
This Phase 1, first-in-human, multiple dose-escalation, randomized, double-blinded, placebo-controlled study is evaluating SYNB1934 in healthy volunteers (HV).
- Trial name
- NCT04984525
- Testing
- SYNB1934, SYNB1618
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Synlogic
Breast Cancer, Lung Cancer
Study to Evaluate Combination Treatment of MGCD0103 and Docetaxel (Taxotere®) for Subjects With Advanced Cancer Tumors
The purpose of this study is to test the combination of an experimental drug known as MGCD0103 given along with an FDA-approved drug called docetaxel.
- Conditions
- Breast Cancer, Lung Cancer, Pulmonary Cancer, Non-Small-Cell Lung Carcinoma
- Trial name
- NCT00511576
- Testing
- MGCD0103 & Docetaxel
- Where
- 2 sites in United States
- Volunteers
- 54 people
- Sponsor
- Mirati Therapeutics Inc.
Pulmonary Hypertension Due to Left Heart Disease
A Study to Learn How Safe the Study Treatment BAY2701250 is, How it Affects the Body and How it Moves Into, Through and Out of the Body in Healthy Male Participants When a Single Amount is Given as an Injection Into the Vein (Intravenous Infusion) or Under the Skin (Subcutaneous Injection)
Researchers are looking for a better way to treat people who have pulmonary hypertension (PH) due to left heart disease. PH due to left heart disease is a condition of high blood pressure in the vessels of the lungs caused by…
- Trial name
- NCT06048120
- Testing
- BAY2701250 IV, BAY2701250 SC
- Where
- Germany
- Volunteers
- 82 people, healthy volunteers welcome
- Sponsor
- Bayer
Hepatocellular Carcinoma
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
- Trial name
- NCT01406574
- Testing
- OPB-31121, OPB-31121 phase2
- Where
- 2 sites in Japan
- Volunteers
- 23 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Advanced Solid Tumors
First in Human Study of YB1-X7 Injection
This clinical trial is an open-label, dose-escalation study designed to evaluate the safety, tolerability, pharmacokinetic, and preliminary efficacy of YB1-X7 injection in subjects with advanced solid tumors.
- Trial name
- NCT06889675
- Testing
- YB1-X7 Injection (IT), YB1-X7 Injection (IV), PD-1 inhibitor
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shaoxing Salvectors Biotechnology LTD.
Multiple Myeloma
A Study to Investigate the Safety and Efficacy of Belantamab for the Treatment of Multiple Myeloma When Used as Monotherapy and in Combination Treatments
The study consists of three parts: Part 1: The primary purpose of this part aims to evaluate the safety, tolerability, and clinical activity of escalating doses of single agent belantamab in participants with refractory multiple…
- Trial name
- DynaMMic-1 (NCT05714839)
- Testing
- Belantamab, Belantamab mafodotin, Pomalidomide
- Where
- 44 sites in United States, Argentina and 11 more
- Volunteers
- 123 people
- Sponsor
- GlaxoSmithKline
Multiple Sclerosis, Myasthenia Gravis
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)
The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or…
- Trial name
- NCT06220201
- Testing
- CC-97540, Fludarabine, Cyclophosphamide
- Where
- 34 sites in United States, Belgium and 4 more
- Volunteers
- 120 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Hypertension
Study to Evaluate the Efficacy and Safety of SLV306 in Subjects With Hypertension
This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine.
- Trial name
- NCT00160212
- Testing
- Daglutril
- Where
- 130 sites in Australia, Bulgaria and 9 more
- Sponsor
- Solvay Pharmaceuticals
Ulcerative Colitis, Crohn's Disease
A Safety Study of Intravenously Administered UTTR1147A in Healthy Volunteers (HVs), Participants With Ulcerative Colitis (UC), and Participants With Crohn's Disease (CD)
This is a randomized, observer-blinded, placebo-controlled study to evaluate safety, tolerability, immunogenicity, and pharmacokinetics of repeat dosing of intravenous (IV) UTTR1147A.
- Trial name
- NCT02749630
- Testing
- UTTR1147A
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Genentech, Inc.
Healthy
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.
- Trial name
- NCT01250730
- Testing
- PF-02341066
- Where
- Japan
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Pfizer
Chronic Graft-versus-host-disease
A Phase 1/2 Study to Evaluate Axatilimab in Participants With Active cGVHD
This is a Phase 1/2, Open-label, Dose Escalation study to investigate axatilimab in participants with active chronic graft versus host disease (cGVHD).
- Trial name
- NCT03604692
- Testing
- axatilimab
- Where
- 11 sites in United States
- Volunteers
- 41 people
- Sponsor
- Syndax Pharmaceuticals
Castrate Resistant Prostate Cancer (CRPC)
MTD Study of Vaccine BP-GMAX-CD1 Plus AP1903 to Treat Castrate Resistant Prostate Cancer
This is a Phase I, non-randomized, multiple-dose, 3+3 dose-escalation study of the safety, pharmacokinetics, biomarkers, preliminary efficacy and patient-reported outcomes of therapeutic vaccine, BPX-101 (formerly BP-GMAX-CD1)…
- Trial name
- NCT00868595
- Testing
- BPX-101, AP1903
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Bellicum Pharmaceuticals
Neoplasms
An Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK3326595 in Participants With Solid Tumors and Non-Hodgkin's Lymphoma
This first time in human (FTIH) open-label, dose escalation study will assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of GSK3326595 in participants with advanced or recurrent…
- Trial name
- Meteor 1 (NCT02783300)
- Testing
- GSK3326595, Pembrolizumab
- Where
- 15 sites in United States, Canada and 2 more
- Volunteers
- 297 people
- Sponsor
- GlaxoSmithKline
Neovascular Age-related Macular Degeneration, Diabetic Macular Edema
Evaluation of IBI302 Injection in nAMD or DME
The purpose of this study is to determine the efficacy and safety of intravitreal IBI302 in the treatment of subjects with neovascular age-related macular degeneration (only in Phase I) or diabetic macular edema.
- Trial name
- NCT05961007
- Testing
- Intravitreal injection of IBI302(dose 1), Intravitreal injection of IBI302(dose 2), Intravitreal injection of IBI302(dose 3)
- Where
- China
- Volunteers
- 234 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Vulvodynia
Dysport in Vulvodynia Phase II Study
This study is designed to define optimal doses of Dysport and evaluate its efficacy and safety compared with placebo for the treatment of vulvodynia.
- Trial name
- DYVINIA (NCT03598777)
- Testing
- Botulinum toxin type A
- Where
- 9 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- Ipsen
Hypertension
Efficacy and Safety of Aliskiren and Atenolol in Adults (>18) With Mild to Moderate Hypertension
This is a study for people diagnosed with hypertension to compare the safety and effectiveness of aliskiren alone and in combination with atenolol. Each patient will be in the study for 12 weeks.
- Trial name
- NCT00262236
- Testing
- Aliskiren
- Where
- 2 sites in Germany, Switzerland
- Volunteers
- 693 people
- Sponsor
- Novartis
Breast Cancer
A Study of ZN-c5 in Subjects With Breast Cancer
This is a Phase 1/2, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ZN-c5 administered orally in subjects with advanced estrogen…
- Trial name
- NCT03560531
- Testing
- ZN-c5, Palbociclib
- Where
- 38 sites in United States, Belarus and 7 more
- Volunteers
- 181 people
- Sponsor
- Zeno Alpha Inc.
Lymphoma, NHL
Phase I, Open-label, Dose-escalation, Safety and PK Study of AZD4877
This study has two parts (A and B). The primary purpose of Part A is to find the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experienced by patients that receive AZD4877 on a twice…
- Conditions
- Lymphoma, NHL, Non-Hodgkin Lymphoma
- Trial name
- NCT00471367
- Testing
- AZD4877
- Where
- 3 sites in United States
- Volunteers
- 44 people
- Sponsor
- AstraZeneca
Recurrent Endometrial Cancer
Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients
Endometrial cancer ranks 11th in terms of incidence (7275 / year) and mortality (2025 deaths/ year). The 5-year overall survivals of patients at diagnosis with locally advanced and metastatic carcinomas are about 50% and 15%…
- Trial name
- ENDOLA (NCT02755844)
- Testing
- Olaparib, metformin, metronomic cyclophosphamide
- Where
- 6 sites in France
- Volunteers
- 35 people
- Sponsor
- Hospices Civils de Lyon
Cancer
A Study of BND-35 in Participants With Advanced Solid Tumors
This is an open-label, multicenter, dose escalation and dose optimization study designed to evaluate safety, tolerability and preliminary anti-tumor activity of BND-35 administered alone and in combination with nivolumab or with…
- Trial name
- NCT06274437
- Testing
- BND-35, Nivolumab, Cetuximab
- Where
- 5 sites in Israel
- Volunteers
- 12 people
- Sponsor
- Biond Biologics
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