Clinical trials: Dose Escalation and Safety
Solid Tumor
A Clinical Study of the Safety and Effectiveness of an Investigational Cell Therapy Given With and Without an Investigational RNA-based Vaccine in Patients With Organ Tumors
This is a Phase I, FIH, open-label, multi-site, dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of claudin 6 (CLDN6) chimeric antigen receptor T cells (CAR-T) with or without CLDN6…
- Trial name
- NCT04503278
- Testing
- CLDN6 CAR-T, CLDN6 uRNA-LPX/CLDN6 modRNA-LPX
- Where
- 12 sites in Australia, Germany and 2 more
- Volunteers
- 214 people
- Sponsor
- BioNTech Cell & Gene Therapies GmbH
Hepatocellular Carcinoma, Liver Cancer
Clinical Study of ET1402L1-CAR T Cells in AFP Expressing Hepatocellular Carcinoma
Clinical study to evaluate safety and pharmacokinetics (primary objectives) and efficacy (secondary objective) of ET1402L1-CART-cells in patients with AFP+ HCC
- Conditions
- Hepatocellular Carcinoma, Liver Cancer, Liver Neoplasms, Metastatic Liver Cancer
- Trial name
- NCT03349255
- Testing
- autologous ET1402L1-CART cells
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Aeon Therapeutics (Shanghai) Co., Ltd.
Primary Hypertension, Secondary Hypertension
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate.
- Trial name
- Lisi-ped (NCT02184858)
- Testing
- lisinopril, ACE-inhibitor
- Where
- Belgium
- Volunteers
- 13 people
- Sponsor
- University Ghent
Anemia, Sickle Cell, Sickle Cell Anemia
Safety Study of MP4CO in Adult Sickle Cell Patients
Sickle Cell Anemia is caused by an inherited hemoglobin disorder. Healthy red blood cells are discoid and can deform and move through small blood vessels to carry oxygen to all parts of the body.
- Conditions
- Anemia, Sickle Cell, Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders
- Trial name
- NCT01356485
- Testing
- MP4CO, Sodium chloride solution
- Where
- 5 sites in France, Jamaica and 2 more
- Volunteers
- 32 people
- Sponsor
- Sangart
Healthy
HIV-1 Vaccine Test in Uninfected Adult Volunteers
This study will test the safety of an experimental vaccine against HIV and examine whether it induces an immune response to HIV. A vaccine is a substance given to try to create resistance or immunity to a disease or infection.
- Trial name
- NCT00045838
- Testing
- VCR-HIVDNA006-00-VP
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections, Bacterial
A Repeat Dose Escalation Study to Investigate the Safety, Tolerability and Pharmacokinetics of GSK1322322 in Healthy Subjects
This study will be the first repeat dose administration of GSK1322322 to investigate safety, tolerability, and pharmacokinetics in healthy subjects as well as elderly volunteer subjects.
- Trial name
- NCT00896558
- Where
- Australia
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HER2-positive Recurrent or Metastatic Malignant Solid Tumor
Phase I Clinical Study of MBS301 in Treatment of HER2 Positive Recurrent or Metastatic Malignant Solid Tumor
This is a phase I study evaluating the safety and pharmacokinetics of MBS301 after intravenous administration in patients with HER-2 positive recurrent or metastatic malignant solid tumors
- Trial name
- NCT03842085
- Testing
- Recombinant Humanized Bispecific Monoclonal Antibody MBS301
- Where
- China
- Volunteers
- 34 people
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
KRAS G12C Mutant Advanced Solid Tumors
A Study of ZG19018 in Patients With KRAS G12C Mutant Advanced Solid Tumors.
Evaluate the safety and tolerability of ZG19018 in Patients with KRAS G12C mutant advanced solid tumors.
- Trial name
- NCT06237400
- Testing
- ZG19018
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Acute Myelogenous Leukemia, Myelodysplastic Syndrome
Safety, Tolerability and Pharmacokinetics of Milademetan Alone and With 5-Azacitidine (AZA) in Acute Myelogenous Leukemia (AML) or High-Risk Myelodysplastic Syndrome (MDS)
This study will take place in parts: Dose Escalation (Part 1): Participants receive milademetan alone with different dose schedules Dose Escalation (Part 1A): Participants receive milademetan in combination with 5-azacytidine…
- Trial name
- NCT02319369
- Testing
- Milademetan, AZA
- Where
- 5 sites in United States
- Volunteers
- 74 people
- Sponsor
- Daiichi Sankyo
HER2-Positive Solid Tumors
JS001 in Combination With RC48-ADC in Treatment of HER2-Positive Advanced Malignant Solid Tumors
This is a non-randomized, open-label, single-arm, multicenter Phase I clinical trial which will evaluate the Safety, Efficacy, Tolerability and Pharmacokinetics of RC48-ADC in combinaton with Anti-PD1 Monoclonal Antibody in…
- Trial name
- NCT04280341
- Testing
- RC48-ADC in combinaton with JS001
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Peking University
Solid Tumors (Phase 1)
Phase I Study of HSK42360-Na in Solid Tumors With BRAF V600 Mutation
This is a phase I, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, PK and PD of HSK42360-Na when given orally in patients with active BRAF V600 mutation locally advanced or metastatic Solid…
- Trial name
- NCT07561554
- Testing
- HSK42360-Na
- Where
- 2 sites in China
- Volunteers
- 159 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Solid Tumors
Study of the Safety and Pharmacokinetics of BGB-283 in Patients With Solid Tumors
This study will evaluate the safety, tolerability, pharmacokinetic profile and treatment effect of a new drug known as BGB-283 in patients with solid tumours.
- Trial name
- NCT02610361
- Testing
- BGB-283
- Where
- 19 sites in Australia, New Zealand
- Volunteers
- 131 people
- Sponsor
- BeiGene
Herpes Zoster (HZ)
Safety and Immunogenicity of the Recombinant Zoster Vaccine, LYB004 in Adults Aged 40 Years and Older
This phase 1 study in China will evaluate the safety and immunogenicity of the Recombinant Zoster Vaccine, LYB004 in adults aged 40 years and older.
- Trial name
- NCT06874842
- Testing
- Low dose antigen and low dose adjuvant of LYB004, Low dose antigen and high dose adjuvant of LYB004, High dose antigen and low dose adjuvant of LYB004
- Where
- China
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- Guangzhou Patronus Biotech Co., Ltd.
Healthy
Study Evaluating Safety of BT01001 Ophthalmic Solution
This Phase I study is designed to evaluate the safety, tolerability, and pharmacokinetic profile of BT01001 Ophthalmic Solution in healthy adult volunteers.
- Trial name
- NCT07313722
- Testing
- BT01001 5 mg/ml（0.5%）, BT01001 10 mg/ml（1.0%）, BT01001 15 mg/ml（1.5%）
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Beyang Therapeutics Co., Ltd.
Healthy Participants, IBD (Inflammatory Bowel Disease)
A Phase I Study of HW201877 in Healthy Subjects
This is a Phase I, randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD), and food effect (FE) of HW201877 in healthy subjects following (1) a single…
- Trial name
- NCT07373457
- Testing
- HW201877 capsules
- Where
- China
- Volunteers
- 104 people, healthy volunteers welcome
- Sponsor
- Wuhan Humanwell Innovative Drug Research and Development Center Limited Company
Healhty
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic of IY-828026 in Healthy Volunteers
A randomized, double-blinded, partial-open, placebo/active-controlled, single/multiple dosing, dose escalation phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic characteristics of…
- Trial name
- NCT07433556
- Testing
- IY-828026, IY-828026A, IY-828026B
- Where
- South Korea
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Il-Yang Pharm. Co., Ltd.
Refractory Ovarian Cancer With Recurrent Symptomatic Malignant Ascites
Phase 1/2a Two-Arm Dose-Escalation Study of BAX69 in Subjects With Malignant Ascites of Ovarian Cancer
The purpose of this study is to evaluate the safety and tolerability of BAX69 monotherapy given either as intraperitoneal (IP) infusion (Single-Route Arm); or as IP infusion after intravenous (IV) infusion (IV+IP) (Double-Route…
- Trial name
- NCT02540356
- Testing
- BAX69 Single-Route Arm, BAX69 Double-Route Arm
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- Baxalta now part of Shire
Eye Diseases, Macular Degeneration
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD
The purpose of this first-in-human study is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of OPT-302 administered as monthly intravitreal injections for 3 months with and without Lucentis™ in patients with…
- Conditions
- Eye Diseases, Macular Degeneration, Retinal Diseases, Retinal Degeneration
- Trial name
- NCT02543229
- Testing
- OPT-302, Lucentis™
- Where
- 14 sites in United States
- Volunteers
- 51 people
- Sponsor
- Opthea Limited
Schizophrenia, Schizo-affective Disorder
Study Investigating the Safety and Tolerability of Multiple Doses of PF-02545920 in Subjects With Schizophrenia
To evaluate the safety and tolerability of multiple doses of PF-02545920 subjects with schizophrenia or schizo-affective disorder who are currently clinically stable and to evaluate the serum and urine pharmacokinetics of…
- Trial name
- NCT00463372
- Testing
- PF-02545920
- Where
- South Africa
- Volunteers
- 40 people
- Sponsor
- Pfizer
Human Papillomavirus-Related Carcinoma
Testing RG1-VLP Vaccine to Prevent HPV-related Cancers
This phase I trial tests the safety, side effects, and best dose of RG1-virus-like particle (VLP) in preventing human papillomavirus (HPV)-related cancers in women.
- Trial name
- NCT05985681
- Testing
- Biospecimen Collection, HPV16 RG1 VLP Vaccine, Questionnaire Administration
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- National Cancer Institute (NCI)
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