Clinical trials: Dose Escalation and Safety
Acute Ischemic Stroke
Transcranial Ultrasound in Clinical SONothrombolysis
This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue…
- Trial name
- TUCSON (NCT00504842)
- Testing
- MRX-801
- Where
- 14 sites in United States, France
- Volunteers
- 72 people
- Sponsor
- ImaRx Therapeutics
Solid Tumors
A Study of Epacadostat and Nivolumab in Combination With Immune Therapies in Participants With Advanced or Metastatic Malignancies (ECHO-208)
The purpose of this study is to determine the safety, tolerability, and efficacy of epacadostat when given in combination with nivolumab and ipilimumab, and in combination with nivolumab and lirilumab, in participant with…
- Trial name
- NCT03347123
- Testing
- Epacadostat, Nivolumab, Ipilimumab
- Where
- 5 sites in United States
- Volunteers
- 11 people
- Sponsor
- Incyte Corporation
Chemotherapy Patients
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of YPEG-Filgrastim in Chemotherapy Patients
This study will assess the safety, tolerability, pharmacokinetics, pharmacodynamics of a single-dose of YPEG-Filgrastim in cancer patients receiving chemotherapy, and will establish dose-response relationships between…
- Trial name
- Filgrastim (NCT01238562)
- Testing
- YPEG-Filgrastim
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Xiamen Amoytop Biotech Co., Ltd.
Hepatocellular Carcinoma
Study of GC33 and Sorafenib in Combination in Advanced or Metastatic Liver Cancer (Hepatocellular Carcinoma)
This phase I trial is studying the safety and best dose of GC33 and Sorafenib in combination in patients with advanced or metastatic liver cancer.
- Trial name
- NCT00976170
- Testing
- GC33(RO5137382), Sorafenib
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 42 people
- Sponsor
- Chugai Pharmaceutical
Solid Tumor of Epithelial Origin, Gastric Cancer
An A/B Dose Escalation Study of AbGn-7 Alone and With FOLFOX7 Treatment in Patients With Advanced Solid Tumors
The purpose of this study is to determine the safety and tolerability profile including the dose limiting toxicity of AbGn-7 in patients with chemo-refractory advanced solid tumor of epithelial origin, and of AbGn-7 in…
- Trial name
- NCT01466569
- Testing
- AbGn-7
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 13 people
- Sponsor
- AbGenomics B.V Taiwan Branch
Alzheimer Disease
A Phase I Clinical Study, Randomized, Single-blind, Placebo-controlled, Multiple Doses, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of Donepezil Patch in Healthy Male Subjects.
Study of the Safety, tolerability and pharmacokinetics with multiple doses of donepezil patch in healthy male subjects
- Trial name
- NCT02178124
- Testing
- Donepezil
- Where
- South Korea
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Icure Pharmaceutical Inc.
Atopic Dermatitis
Safety, Tolerability, and Pharmacokinetic Study of QLM3003 in Healthy Adult Subjects
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) doses of QLM3003 compared to placebo. Also, pharmacokinetics (PK) of qlm3003 will be evaluated.
- Trial name
- NCT05932888
- Testing
- QLM3003
- Where
- China
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Undifferentiated Pleomorphic Sarcoma, Myxofibrosarcoma
CAB-AXL-ADC Safety and Efficacy Study in Adult and Adolescent Patients With Sarcoma
The objective of this study is to assess the safety and efficacy of mecbotamab vedotin (BA3011) in solid tumors.
- Trial name
- NCT03425279
- Testing
- CAB-AXL-ADC, PD-1 inhibitor
- Where
- 40 sites in United States, Hong Kong and 1 more
- Volunteers
- 245 people
- Sponsor
- BioAtla, Inc.
Lymphoma
Safety Study of Darinaparsin in Combination With Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) to Treat Lymphoma
This study is a Phase I trial of Darinaparsin in combination with CHOP for the treatment of lymphoma. Eligible patients will not have had any previous anti-cancer treatment and will be eligible to receive CHOP alone.
- Trial name
- NCT01139359
- Testing
- darinaparsin, CHOP
- Sponsor
- Alaunos Therapeutics
Ovarian Cancer, Endometrial Cancer
Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
The primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study.
- Conditions
- Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor, Testicular Germ Cell Tumor
- Trial name
- NCT06276491
- Testing
- XmAb541
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 282 people
- Sponsor
- Xencor, Inc.
Advanced Melanoma, Stage III and IV Melanoma
Safety and Immune Response to a Multi-component Immune Based Therapy (MKC1106-MT) for Patients With Melanoma.
A dose comparison of a multi-component active immunotherapy designed to stimulate an immune reaction to specific tumor associated antigens which are highly expressed on melanomas.
- Trial name
- NCT00688090
- Testing
- Biological: MKC1106-MT, Biological: MKCC1106-MT
- Where
- 2 sites in United States
- Volunteers
- 19 people
- Sponsor
- Mannkind Corporation
Erectile Dysfunction
Multiple Dose Escalation Study (14 Days) to Investigate Safety, Tolerability, PK and PD of Vardenafil and BAY60-4552
Safety, tolerability, pharmacokinetics and pharmacodynamics will be investigated in this multiple dose escalation study. In three treatments groups different dosages of BAY 60-4552 and vardenafil will be given with patients with…
- Trial name
- NCT01110590
- Testing
- BAY60-4552 + Vardenafil
- Where
- Germany
- Volunteers
- 37 people
- Sponsor
- Bayer
Hodgkin's Lymphoma
Safety and Efficacy Study of TNX-650 to Treat Refractory Hodgkin's Lymphoma
The purpose of this study is to determine the safety and effectiveness of TNX-650 for Injection when administered to patients with refractory Hodgkin's lymphoma.
- Trial name
- NCT00441818
- Testing
- TNX-650
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Tanox
Colorectal Cancer
A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
This is a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal…
- Trial name
- NCT00497497
- Testing
- bevacizumab, cetuximab, FOLFIRI regimen
- Volunteers
- 20 people
- Sponsor
- Genentech, Inc.
Advanced Solid Tumor
A Study of HC006 in Subjects With Advanced Solid Tumors
The purpose of this study is to characterize the safety, tolerability, pharmacokinetics (PK), Immunogenicity and preliminary antitumor activity of HC006 in subjects with advanced solid tumor malignancies.
- Trial name
- NCT06304571
- Testing
- HC006
- Where
- China
- Volunteers
- 76 people
- Sponsor
- HC Biopharma Inc.
Tumors, Hypoxia
A Phase I Study of the Safety, Pharmacokinetics, and Anti-Tumor Activity of TH-302 in Patients With Advanced Solid Tumors
This is a phase I, multi-center, open-label, dose-escalation study of TH-302 in patients with advanced solid tumors. TH-302 is a hypoxia activated product designed to exploit the hypoxic nature of tumors.
- Trial name
- NCT00495144
- Testing
- TH-302
- Where
- 7 sites in United States
- Volunteers
- 129 people
- Sponsor
- Threshold Pharmaceuticals
Long QT Syndrome
Study of LQT-1213 on QTc-induced Prolongation in Healthy Adult Subjects (Part1) and on Congenital Long QT in Patients Diagnosed With Type 2 or 3 Long QT Syndrome (Part 2).
Part 1: This is a Phase 1b, randomized, double-blind, crossover, dose escalation, placebo-controlled study to evaluate the effect of oral LQT-1213 on dofetilide-induced QTc prolongation in healthy adult subjects.
- Trial name
- NCT05906732
- Testing
- LQT-1213, Dofetilide 250 μg Cap
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Thryv Therapeutics, Inc.
Homocystinuria
Safety, Tolerability and Pharmacodynamics of SYNB1353 in Healthy Adult Volunteers
This is a Phase 1, double-blind (Sponsor-open), placebo-controlled, randomized, dose-escalation, inpatient study using a multiple-ascending dose (MAD) design to assess the safety, tolerability, and PD of SYNB1353 in HVs.
- Trial name
- HCU (NCT05462132)
- Testing
- SYNB1353
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Synlogic
Healthy Volunteers
a Safety and Tolerability Study of EP-9001A in Healthy Volunteers
Nerve Growth Factor(NGF)plays an important role in the pathogenesis of neuropathic pain including cancer pain. EP-9001A is a humanized monoclonal antibody targeting NGF, thus thought to alleviate neuropathic pain though the…
- Trial name
- NCT05278611
- Testing
- EP-9001A
- Where
- China
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chengdu Easton Biopharmaceuticals Co,Ltd
Mature B-cell Neoplasms
A Study of Hutchison MediPharma Limited(HMPL)-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms
A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of HMPL-523 in Patients With Relapsed or Refractory Mature B-cell Neoplasms
- Trial name
- NCT02857998
- Testing
- HMPL-523
- Where
- 2 sites in China
- Volunteers
- 134 people
- Sponsor
- Hutchison Medipharma Limited
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