Clinical trials: Dose Escalation and Safety
Solid Tumor Cancer, Lymphoma
Dose-Escalating Study Of SB-485232 Administered Intravenously Every 28 Days To Adults With Solid Tumors Or Lymphomas
SB-485232 will be administered as five daily intravenous (IV) infusions repeated every 28 days in adult subjects with advanced solid tumors or lymphomas.
- Trial name
- NCT00085904
- Testing
- SB-485232
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline
Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
The purpose of this study is to evaluate the safety, tolerability, and efficacy of two different treatment combinations of tulmimetostat in participants with de novo or recurrent metastatic hormone-sensitive prostate cancer…
- Trial name
- TulmiSTAR-02 (NCT07190300)
- Testing
- Tulmimetostat, Darolutamide, Abiraterone
- Where
- 31 sites in United States, Australia and 12 more
- Volunteers
- 181 people
- Sponsor
- Novartis Pharmaceuticals
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
Filariasis
Safety, Tolerability and PK of Multiple-ascending Doses of Emodepside
The study evaluates safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of emodepside, after administration as a Liquid Service Formulation (LSF), over 10 days, in healthy male caucasian subjects.
- Trial name
- NCT03383614
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Drugs for Neglected Diseases
Malaria,Falciparum
Safety, Pharmacokinetics, and Plasmodium Falciparum Transmission-reducing Activity of Monoclonal Antibody TB31F in Mali
Mali faces a significant challenge with malaria, particularly among its younger population. While existing measures like seasonal chemoprevention and vaccination have shown efficacy, further innovations are necessary to combat…
- Trial name
- NCT06413108
- Testing
- TB31F, Normal saline
- Where
- Mali
- Volunteers
- 167 people, healthy volunteers welcome
- Sponsor
- Radboud University Medical Center
Carcinoid, Neuroendocrine
Safety Study of Seneca Valley Virus in Patients With Solid Tumors With Neuroendocrine Features
The primary purpose of the study is to determine if Seneca Valley Virus may be administered safely to patients with certain types of advanced cancer.
- Trial name
- NCT00314925
- Testing
- Seneca Valley Virus (biological agent)
- Where
- 10 sites in United States
- Volunteers
- 60 people
- Sponsor
- Neotropix
Patients w/Advanced Cancer That Failed Std of Care Therapy
A Phase IB Dose Escalation Study of Lipocurc in Patients With Cancer
This is a single center in patient/outpatient, uncontrolled dose escalating study in cancer patients to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of body surface area adjusted doses of liposomal curcumin…
- Trial name
- NCT02138955
- Testing
- Liposomeal curcumin
- Where
- 2 sites in Austria
- Volunteers
- 30 people
- Sponsor
- SignPath Pharma, Inc.
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MLS101 in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat various neurological and psychiatric conditions.
- Trial name
- NCT06326606
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Cholangiocarcinoma
A Phase I/II Safety and Efficacy Study of PCI of Gemcitabine and Chemotherapy in Patients With Cholangiocarcinomas
This is a Phase I Dose Escalation Study in which the safety, tolerability and efficacy of Amphinex®--induced Photochemical Internalisation (PCI) of Gemcitabine followed by Gemcitabine/Cisplatin Chemotherapy will be assessed in…
- Trial name
- NCT01900158
- Testing
- Amphinex, Gemcitabine and Cisplatin
- Where
- 11 sites in France, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- PCI Biotech AS
Recurrent Breast Carcinoma, Recurrent Fallopian Tube Carcinoma
Mirvetuximab Soravtansine and Gemcitabine Hydrochloride in Treating Patients With FRalpha-Positive Recurrent Ovarian, Primary Peritoneal, Fallopian Tube, Endometrial, or Triple Negative Breast Cancer
This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and gemcitabine hydrochloride in treating patients with folate receptor (FR) alpha-positive ovarian, primary peritoneal, fallopian tube…
- Conditions
- Recurrent Breast Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma
- Trial name
- NCT02996825
- Testing
- Gemcitabine, Gemcitabine Hydrochloride, Laboratory Biomarker Analysis
- Where
- 2 sites in United States
- Volunteers
- 44 people
- Sponsor
- City of Hope Medical Center
Influenza, Human
A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults
The purpose of this first-time-in-human (FTiH) study is to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline's (GSK) messenger RNA (mRNA)-based monovalent vaccine (GSK4382276A) candidate against influenza in…
- Trial name
- NCT05446740
- Testing
- GSK4382276A Dose level 1, GSK4382276A Dose level 2, GSK4382276A Dose level 3
- Where
- 7 sites in Belgium, Canada and 1 more
- Volunteers
- 324 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Spasticity
A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity.
The purpose of the study is to assess the safety and efficacy of increasing doses of Corabotase (also known as IPN10200) with the aim to evaluate the Pharmacodynamics (PD) profile of Corabotase and to establish the total…
- Trial name
- LANTIMA (NCT04752774)
- Testing
- Corabotase, Dysport
- Where
- 81 sites in United States, Austria and 12 more
- Volunteers
- 240 people
- Sponsor
- Ipsen
Healthy
An Open Study of the Safety and Pharmacokinetics of a Medicinal Product for Emergency Prevention of Ebola
This Phase I clinical trial was developed to study drug safety, tolerability, and pharmacokinetics of the medicine for Ebola fever emergency prevention based on monoclonal recombinant antibodies in single use in healthy…
- Trial name
- 03-AT-2017 (NCT03428347)
- Testing
- GamEMab
- Where
- Russia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
HIV Infections
A Study to Investigate Pharmacokinetics (PK), Safety, and Tolerability of VH4367310 in Healthy Adult Participants
This study evaluates the PK, safety, and tolerability of a single increasing dose of VH4367310, a cabotegravir (CAB) prodrug, when administered intramuscularly in healthy adult participants 18 to 55 years of age.
- Trial name
- NCT07818915
- Testing
- VH4367310
- Where
- 2 sites in United States
- Volunteers
- 112 people, healthy volunteers welcome
- Sponsor
- ViiV Healthcare
Melanoma
Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma
The goal of this clinical research study is to find the highest tolerated dose of rAd.CD40L (also called ISF35) when given with pembrolizumab to patients with melanoma.
- Trial name
- NCT02719015
- Testing
- rAd.CD40L, Pembrolizumab
- Sponsor
- M.D. Anderson Cancer Center
Atopic Dermatitis
Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Participants With Moderate to Severe AD
Safety, tolerability, and preliminary efficacy of soquelitinib in participants with moderate to severe AD
- Trial name
- NCT06345404
- Testing
- Soquelitinib
- Where
- 16 sites in United States
- Volunteers
- 82 people
- Sponsor
- Corvus Pharmaceuticals, Inc.
Pemphigus Vulgaris
Safety Study of PI-0824 to Treat Pemphigus Vulgaris
The purpose of this study is to determine if the use of PI-0824 in patients with Pemphigus vulgaris is safe.
- Trial name
- NCT00063752
- Testing
- PI-0824
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Peptimmune
Pneumococcal Vaccine
A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine
The objectives of this first-in-human study is to evaluate the tolerability, safety, and immunogenicity of MVX01, a pneumococcal vaccine candidate, at four dose levels.
- Trial name
- NCT06337643
- Testing
- MVX01
- Where
- 2 sites in United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Matrivax Research and Development Corporation
Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients…
- Trial name
- NCT04467515
- Testing
- CAM-H2
- Where
- 12 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Precirix
Advanced Solid Tumors
This Is The First Study Using Escalating Doses Of PF-03758309, An Oral Compound, In Patients With Advanced Solid Tumors
This is the first study using PF-03758309, an oral compound, in patients with advanced solid tumors. In this study different doses of PF-03758309 will be administered to different groups of patients.
- Trial name
- NCT00932126
- Testing
- PF-03758309
- Where
- 3 sites in United States, Australia
- Volunteers
- 35 people
- Sponsor
- Pfizer
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