Clinical trials: Dose-escalation
Congenital Adrenal Hyperplasia, CAH - Congenital Adrenal Hyperplasia
Study of SPR001 in Adults With Classic Congenital Adrenal Hyperplasia
This is a multicenter Phase 2, multiple dose, dose escalation study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of SPR001 in adult patients with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT03257462
- Testing
- SPR001
- Where
- 9 sites in United States
- Volunteers
- 24 people
- Sponsor
- Spruce Biosciences
Solid Tumor, Multiple Myeloma
Dose Escalation Trial of Dalotuzumab (MK-0646) in Advanced Solid Tumors and Multiple Myeloma (MK-0646-001)
This study will look for the highest tolerated dose of dalotuzumab (MK-0646) given as weekly, every other week. or a every three week infusion.
- Trial name
- NCT00701103
- Testing
- Dalotuzumab
- Volunteers
- 80 people
- Sponsor
- Merck Sharp & Dohme LLC
Solid Tumors and Hematologic Malignancy
An Open-Label, Dose-Escalation Study of INCB054329 in Patients With Advanced Malignancies
This was a study of INCB054329 given to patients with advanced malignancies that were conducted in three treatment groups. Each treatment group had a dose escalation (Part 1) and a dose expansion (Part 3), two of the treatment…
- Trial name
- NCT02431260
- Testing
- INCB054329 Monotherapy
- Where
- 12 sites in United States
- Volunteers
- 69 people
- Sponsor
- Incyte Corporation
Cirrhosis
A Trial of OPC-41061 in Patients With Hepatic Edema - Investigation of the Safety of Treatment at 7.5 mg Beyond 7 Days and of the Effect of Dose Escalation to 15 mg
OPC-41061 will be orally administered at 7.5 mg/day for 7 days to cirrhosis patients with ascites despite having received conventional diuretic therapy.
- Trial name
- NCT01048788
- Testing
- OPC-41061
- Where
- 6 sites in Japan
- Volunteers
- 51 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Parkinson's Disease (PD)
Tolerability, Pharmacokinetics and Pharmacodynamics of BIA 9-1067
The purpose of this study is to assess the tolerability of BIA 9-1067 after multiple rising dose regimens of BIA 9-1067.
- Trial name
- NCT02071810
- Testing
- BIA 9-1067
- Where
- France
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Bial - Portela C S.A.
Hepatitis B
A Study on the Safety and Immune Response of AS37 Together With Hepatitis B Antigen in Adults Aged 18-45 Years
This study is conducted to assess safety and immunogenicity of GSK's HBsAg vaccine adjuvanted with GSK's AS37 adjuvant system in healthy, HBs naïve, adults aged 18-45 years and to differentiate GSK's AS37 adjuvant system from…
- Trial name
- NCT05561673
- Testing
- GSK's Hepatitis B vaccine adjuvanted with aluminum hydroxide, GSK's HBsAg candidate vaccine adjuvanted with GSK's AS03 adjuvant system, GSK's Hepatitis B vaccine adjuvanted with GSK's AS04 adjuvant system
- Where
- 5 sites in Belgium, Germany and 1 more
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Malignant Glioma, Glioblastoma
Stage 1: Marizomib + Bevacizumab in WHO Gr IV GBM; Stage 2: Marizomib Alone; Stage 3: Combination of Marizomib and Bevacizumab
This is a Phase 1/2 clinical trial to evaluate a new combination of drugs, marizomib (MRZ) and bevacizumab (BEV; Avastin®), for the treatment of WHO Grade IV malignant glioma.
- Trial name
- NCT02330562
- Testing
- MRZ, BEV
- Where
- 5 sites in United States, Canada
- Volunteers
- 121 people
- Sponsor
- Celgene
Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma
A Study of the Safety, Tolerability, and Effects of Cobimetinib and GDC-0994 in Patients With Locally Advanced or Metastatic Solid Tumors
This is a two-stage dose-escalation study to assess the safety, tolerability and effects of oral dosing of cobimetinib and GDC-0994 administered in combination in patients with histologically confirmed, locally advanced, or…
- Trial name
- NCT02457793
- Testing
- Cobimetinib, GDC-0994
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Genentech, Inc.
Dermatitis, Atopic
A Study for AR100DP1 in Mild to Moderate Atopic Dermatitis (AD)
This is a Phase I/IIa Open-Label, Dose-Escalation Study to Determine the Safety, Tolerability, and Efficacy of AR100DP1 in Health Subjects, and Subjects with Mild to Moderate Atopic Dermatitis.
- Trial name
- NCT04220411
- Testing
- AR100DP1
- Where
- Taiwan
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- Arjil Pharmaceuticals LLC
Colorectal Cancer Metastatic
MGD007 Combined With MGA012 in Relapsed/Refractory Metastatic Colorectal Cancer
The primary goal of this study is to characterize the safety, tolerability, and maximum tolerated dose (MTD) of MGD007 when combined with MGA012.
- Trial name
- NCT03531632
- Testing
- MGD007 + MGA012
- Where
- 6 sites in United States
- Volunteers
- 38 people
- Sponsor
- MacroGenics
Tumors Characterized by Genetic Abnormalities of ALK
A Dose Escalation/Expansion Study of LDK378 in Patients With Tumors Characterized by Genetic Abnormalities in Anaplastic Lymphoma Kinase
This study assessed the safety and efficacy of LDK378 in adult patients with genetic abnormalities in anaplastic lymphoma kinase (ALK).
- Trial name
- NCT01283516
- Testing
- LDK378
- Where
- 21 sites in United States, Australia and 9 more
- Volunteers
- 304 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Colorectal Cancer
Phase Ib/II Study of Efficacy and Safety of MEK162 and Panitumumab, in Adult mCRC Patients With Mutant or Wild-type RAS Tumors
The primary purpose of the phase Ib is to estimate the MTD/RPD2 and of the phase II is to assess the anti-tumor activity of MEK162 in combination with panitumumab.
- Trial name
- NCT01927341
- Testing
- MEK162, Panitumumab
- Where
- 8 sites in United States, Belgium and 5 more
- Volunteers
- 53 people
- Sponsor
- Pfizer
Type 2 Diabetes Mellitus
Effects and Safety of OPK-88003 Dose Escalation in Type 2 Diabetes Subjects
This study will evaluate the effect of dose escalation of once-weekly (QW) subcutaneous (SC) OPK-8003 injections vs placebo on HbA1c absolute change from baseline at 30 weeks in subjects with type 2 diabetes mellitus (T2DM)…
- Trial name
- NCT03406377
- Testing
- OPK-88003
- Where
- 3 sites in United States
- Volunteers
- 113 people
- Sponsor
- OPKO Health, Inc.
Chronic Refractory Cough
A Dose Escalation Study of BLU-5937 in Unexplained or Refractory Chronic Cough
This is a multi-center, randomized, double-blind, placebo-controlled, crossover, dose escalation study of BLU-5937 in subjects with unexplained or refractory chronic cough
- Trial name
- RELIEF (NCT03979638)
- Testing
- BLU-5937
- Where
- 16 sites in United States, United Kingdom
- Volunteers
- 68 people
- Sponsor
- Bellus Health Inc. - a GSK company
HIV Antibodies
Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
Background: The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same.
- Trial name
- VRC 609 (NCT03538626)
- Testing
- VRC-HIVMAB091-00-AB, rHuPH20
- Where
- United States
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Leukemia, Lymphocytic, Chronic, B-Cell
BI836826 Dose Escalation in Relapsed Chronic Lymphocytic Leukaemia (CLL)
Adult patients with chronic lymphocytic leukaemia who experience a relapse after at least two prior treatment regimens may be enrolled in this trial.
- Trial name
- NCT01296932
- Testing
- BI 836826
- Where
- 10 sites in Belgium, France and 1 more
- Volunteers
- 37 people
- Sponsor
- Boehringer Ingelheim
Hodgkin Lymphoma, Non-Hodgkin Lymphoma
Study of ADCT-301 in Patients With Relapsed or Refractory Hodgkin and Non-Hodgkin Lymphoma
This study evaluates camidanlumab tesirine in participants with relapsed/refractory Non-Hodgkin or Hodgkin lymphoma.
- Trial name
- NCT02432235
- Testing
- Camidanlumab tesirine
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 133 people
- Sponsor
- ADC Therapeutics S.A.
Healthy
Safety and Tolerability Study of N6022 in Healthy Subjects
The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.
- Trial name
- NCT01147406
- Testing
- N6022
- Where
- United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Nivalis Therapeutics, Inc.
Breast Cancer
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal…
- Trial name
- NCT02561832
- Testing
- Olaparib, Carboplatin, Anthracycline
- Where
- 7 sites in United States, Spain
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Immune Thrombocytopenia Purpura
Single Rising Dose Study of MK-8723 in Healthy Participants and Participants With Immune Thrombocytopenia Purpura (MK-8723-001)
The primary objectives of this study are to assess the safety and tolerability of single rising doses of MK-8723 in healthy adult participants and adult participants with chronic immune thrombocytopenia purpura (ITP) and to…
- Trial name
- NCT01963260
- Testing
- MK-8723
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC