Clinical trials: Dose Escalation and Safety
Neoplasms
A Study of RO5479599 Alone or in Combination With Cetuximab or Erlotinib in Participants With Metastatic and/or Locally Advanced Malignant Human Epidermal Growth Factor Receptor (HER3) Expressing Solid Tumors of Epithelial Cell Origin
This dose-escalating study consists of 3 parts (A, B and C) and will evaluate the safety, pharmacokinetics and efficacy of RO5479599, alone or in combination with cetuximab or erlotinib, in participants with metastatic and/or…
- Trial name
- NCT01482377
- Testing
- RO5479599, Cetuximab, Erlotinib
- Where
- 12 sites in Denmark, Netherlands and 2 more
- Volunteers
- 145 people
- Sponsor
- Hoffmann-La Roche
Tumors, Neoplasm Metastasis
MAD in Cancer Patients: Safety of BMS-582664 in Patients With Advanced or Metastatic Solid Tumors
This is a Phase I dose escalation study to determine the safety, pharmacokinetics and pharmacodynamics of BMS-582664 in patients with advanced or metastatic solid tumors.
- Trial name
- NCT00207103
- Testing
- Brivanib, Brivanab
- Where
- 8 sites in United States, Canada and 2 more
- Volunteers
- 68 people
- Sponsor
- Bristol-Myers Squibb
Solid Tumor, Metastatic Tumor
A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors
A Phase 1 dose escalation study to determine if axatilimab as monotherapy and axatilimab in combination with a fixed dose of durvalumab will be sufficiently safe and well-tolerated at biologically active doses to warrant further…
- Conditions
- Solid Tumor, Metastatic Tumor, Locally Advanced Malignant Neoplasm, Unresectable Malignant Neoplasm
- Trial name
- NCT03238027
- Testing
- Axatilimab, Durvalumab
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- Syndax Pharmaceuticals
Neoplasms
A Trial to Evaluate Epothilone D in Patients With Advanced Solid Tumors
Epothilone D represents one of a class of cytotoxic macrolides capable of causing mitotic arrest by stabilizing tubulin polymerization.
- Trial name
- NCT00030173
- Testing
- Epothilone D (KOS-862)
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Bristol-Myers Squibb
Healthy
Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of TG-0054 With Single IV Doses Escalation in Healthy Volunteers
TG-0054 is a CXCR4 antagonist with stem cell mobilization effect as proven in animal model, this is the fist in human study to investigator the safety, tolerability and PK/PD in healthy subjects.
- Trial name
- NCT00822341
- Testing
- TG-0054
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- GPCR Therapeutics, Inc.
Acute Myeloid Leukemia, Acute Myelogenous Leukemia
Study of a Novel BET Inhibitor FT-1101 in Patients With Relapsed or Refractory Hematologic Malignancies
This is an open-label, multicenter, dose-escalation Phase 1/1b study in patients with acute myelogenous leukemia (AML)/MDS or non-Hodgkin Lymphoma (NHL), intended to investigate safety, pharmacokinetics, and the pharmacodynamic…
- Conditions
- Acute Myeloid Leukemia, Acute Myelogenous Leukemia, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma
- Trial name
- NCT02543879
- Testing
- FT-1101, Azacitidine
- Where
- 8 sites in United States
- Volunteers
- 94 people
- Sponsor
- Forma Therapeutics, Inc.
Pancreatic Ductal Adenocarcinoma (PDAC)
A Study of MR001 Combined With Chemotherapy in Patients With Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) After First-line Therapy
This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 Combined with Chemotherapy in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma…
- Trial name
- NCT07235202
- Testing
- MR001, Irinotecan Liposome Injection combined with 5-FU/LV, Nab-paclitaxel
- Where
- 4 sites in China
- Volunteers
- 45 people
- Sponsor
- Shenzhen Majory Biotechnology Co., Ltd.
Recurrent Small Cell Lung Cancer
Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard…
- Trial name
- NCT01901653
- Testing
- Rovalpituzumab tesirine (SC16LD6.5)
- Where
- 8 sites in United States
- Volunteers
- 82 people
- Sponsor
- Stemcentrx
Solid Tumors, Acute Myeloid Leukemia
A Study of PLX51107 in Advanced Malignancies
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the investigational drug PLX51107 in subjects with advanced solid tumors (including lymphoma), and advanced…
- Conditions
- Solid Tumors, Acute Myeloid Leukemia, Myelodysplastic Syndrome, Non-Hodgkin's Lymphoma
- Trial name
- NCT02683395
- Testing
- PLX51107
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Plexxikon
Breast Cancer
CNF2024 (BIIB021) HER2- (QD) HER2+ (BIW w/Herceptin) PK/PD Study
The goal of this clinical research study is to study the drug CNF2024 as a single agent or in combination with trastuzumab in patients with advanced breast cancer and to: find the highest dose of the drug CNF2024 as a single…
- Trial name
- NCT00412412
- Testing
- CNF2024, CNF2024 + trastuzumab
- Where
- 3 sites in United States
- Volunteers
- 34 people
- Sponsor
- Biogen
Muscular Dystrophy, Duchenne
Modified Diet Trial: A Study of SMT C1100 in Paediatric Patients With DMD Who Follow a Balanced Diet
Placebo-controlled, multi-centre, randomized, double-blind dose escalation study. The aim is to evaluate the pharmacokinetics (PK) and safety of SMT C1100 in paediatric patients with Duchenne Muscular Dystrophy (DMD) who follow a…
- Trial name
- NCT02383511
- Testing
- SMT C1100
- Where
- 4 sites in United Kingdom
- Volunteers
- 12 people
- Sponsor
- Summit Therapeutics
Disorder of Knee
Open-Label Study of Oxycodone/APAP to Treat Post-Operative Pain Following Arthroscopic Knee Surgery
This is a pilot trial using this product in patients for the management of pain after outpatient arthroscopic knee surgery. This is an open-label study and the two active ingredients are well known pharmacologic entities.
- Trial name
- NCT02391844
- Testing
- Oxycodone
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- International Clinical Research Institute
Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid
Autologous Polyclonal Tregs for Lupus
The primary purpose of this Phase 1 study is to evaluate the safety, tolerability, and effect of 3 different doses of Treg therapy in adults with skin (cutaneous) involvement of their lupus.
- Conditions
- Lupus Erythematosus, Cutaneous, Lupus Erythematosus, Discoid, Lupus Erythematosus, Systemic
- Trial name
- NCT02428309
- Testing
- Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Solid Tumors, Multiple Myeloma
Phase I, Multicenter, Dose Escalation Study of DCR-MYC in Patients With Solid Tumors, Multiple Myeloma, or Lymphoma
The purpose of this study is to assess the safety and tolerability of the investigational anticancer drug DCR-MYC. DCR-MYC is a novel synthetic double-stranded RNA in a stable lipid particle suspension that targets the oncogene…
- Conditions
- Solid Tumors, Multiple Myeloma, Non-Hodgkins Lymphoma, Pancreatic Neuroendocrine Tumors
- Trial name
- NCT02110563
- Testing
- DCR-MYC
- Where
- 6 sites in United States
- Volunteers
- 50 people
- Sponsor
- Dicerna Pharmaceuticals, Inc., a Novo Nordisk company
Prostate Cancer
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer
Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients with Prostate Cancer.
- Trial name
- IM1 (NCT01491971)
- Testing
- Degarelix
- Where
- 15 sites in United States, Canada
- Volunteers
- 76 people
- Sponsor
- Ferring Pharmaceuticals
Advanced Solid Tumor Cancer
Early-phase Trial to Assess the Safety and Preliminary Efficacy of BNT3214 in Adults With Advanced Solid Tumors
This study is the first time the drug BNT3214 (also referred to as PM8102) will be tested in people. It is designed to find out if the drug is safe and how well it works for adults with advanced solid tumors.
- Trial name
- NCT07455734
- Testing
- BNT3214
- Where
- 16 sites in Australia, China and 2 more
- Volunteers
- 533 people
- Sponsor
- BioNTech SE
Multiple Myeloma
Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of GSK2857916
This study will assess the safety, pharmacokinetic (PK), pharmacodynamic (PD) and the therapeutic potential of GSK2857916 in subjects with multiple myeloma (MM) and lymphomas that express B cell maturation antigen (BCMA).
- Trial name
- NCT02064387
- Testing
- GSK2857916
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 79 people
- Sponsor
- GlaxoSmithKline
Myeloproliferative Neoplasm (MPN), Myelofibrosis，MF
Study of Flonoltinib Maleate Tablets in the Treatment of Proliferative Bone Marrow Tumors
Flonoltinib Maleate (FM) targets Janus kinase 2 (JAK2) and FMS-like tyrosine kinase 3 (FLT3). FM is a dual target inhibitor of JAK2/FLT3.FM has the activity of inhibiting JAK2 signaling pathway, and pharmacodynamics evaluation…
- Trial name
- NCT05115344
- Testing
- flonoltinib 25mg, flonoltinib 50mg, flonoltinib 100mg
- Sponsor
- Guizhou Bailing Group Pharmaceutical Co Ltd
Scleroderma, Systemic
A Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of GSK2330811 in Healthy Subjects
GSK2330811 is a humanised monoclonal antibody, that blocks Oncostatin M (OSM), which is being developed for the treatment of inflammatory and fibrotic diseases.
- Trial name
- NCT02386436
- Testing
- GSK2330811
- Where
- United Kingdom
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Developmental and Epileptic Encephalopathy, Dravet Syndrome
Study to Investigate LP352 in Subjects With Developmental and Epileptic Encephalopathies
The objective of this study is to assess the safety, tolerability, efficacy, and pharmacokinetics of adjunctive therapy of LP352 in adults and adolescents with developmental and epileptic encephalopathies.
- Conditions
- Developmental and Epileptic Encephalopathy, Dravet Syndrome, Lennox Gastaut Syndrome
- Trial name
- PACIFIC (NCT05364021)
- Testing
- LP352
- Where
- 34 sites in United States, Australia
- Volunteers
- 52 people
- Sponsor
- Longboard Pharmaceuticals
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