Clinical trials: Dose Escalation and Safety
Advanced Cancer, Refractory Cancer
A Safety Study of an Oral EGFR Inhibitor, AV-412, Administered Three Times Weekly in Advanced Solid Tumor Patients
The Epidermal Growth Factor Receptor (EGFR) is a validated target for the treatment of cancer, and agents targeting EGFR such as erlotinib (Tarceva®) are approved by the FDA for treatment of various solid tumors.
- Trial name
- NCT00551850
- Testing
- AV-412
- Where
- 4 sites in United States
- Volunteers
- 37 people
- Sponsor
- AVEO Pharmaceuticals, Inc.
Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers
A Study of the Safety and Pharmacology of GDC-0941 in Combination With Erlotinib in Patients With Advanced Solid Tumors
This is an open-label, multicenter, Phase Ib dose-escalation study to assess the safety, tolerability, and pharmacokinetics (PK) of oral (PO) GDC-0941 administered in combination with PO erlotinib in patients with advanced solid…
- Trial name
- NCT00975182
- Testing
- GDC-0941, erlotinib HCl
- Where
- 4 sites in United States, Netherlands
- Volunteers
- 58 people
- Sponsor
- Genentech, Inc.
Healthy
Study to Evaluate the Safety of MEDI-534 Vaccine Against Respiratory Syncytial Virus (RSV) and Parainfluenza Virus Type 3 (PIV3) in Healthy Children
This is a randomized, double-blind, placebo-controlled, dose-escalation, Phase 1, multi-center study to evaluate the safety, tolerability, immunogenicity, and viral shedding of MEDI-534 in healthy children 1-9 years of age who…
- Trial name
- NCT00345670
- Testing
- MEDI-534
- Where
- 12 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma
A Dose Escalation, Safety and Activity Study of CDX-014 in Patients With Renal Cell Carcinoma and Ovarian Clear Cell Carcinoma
This is a study to determine the safety of CDX-014 and effectiveness (how well the drug works).
- Conditions
- Renal Cell Carcinoma (RCC), Clear-cell Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Kidney Neoplasms
- Trial name
- NCT02837991
- Testing
- CDX-014
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Celldex Therapeutics
Hypertension, Isolated Systolic Hypertension (ISH)
A Single Rising Dose Study of MK-8150 (MK-8150-001)
This study will evaluate the safety and tolerability of MK-8150 and its effect on central systolic blood pressure (cSBP) and heart rate corrected augmentation index (AIx) when given as single oral doses in healthy males and in…
- Trial name
- NCT01590810
- Testing
- MK-8150 2.0 mg, MK-8150 10 mg, MK-8150 40 mg
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Influenza
A Study to Evaluate the Safety and Immunogenicity of a Single Dose of H1ssF-3928 mRNA-LNP in Healthy Adults
This is a Phase 1, single-site, open-label, comparator-controlled dose escalating study of an intramuscularly (IM) administered mRNA-LNP vaccine encoding for (Vaccine Research Center) VRC H1ssF 3928 of up to 50 healthy adult…
- Trial name
- NCT05755620
- Testing
- Influenza Virus Quadrivalent Inactivated Vaccine, Sodium Chloride, 0.9%, VRC-FLUNPF099-00-VP (H1ssF_3928)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Adult Solid Neoplasm, Estrogen Receptor Negative
Weekly Doses of Cilengitide and Paclitaxel in Treating Patients With Advanced Solid Tumors That Cannot Be Removed by Surgery
This phase I trial studies the side effects and the best dose of cilengitide when given together with paclitaxel weekly in treating patients with solid tumors that have spread nearby or to other areas of the body and cannot be…
- Conditions
- Adult Solid Neoplasm, Estrogen Receptor Negative, HER2/Neu Negative, Male Breast Carcinoma
- Trial name
- NCT01276496
- Testing
- Cilengitide, Laboratory Biomarker Analysis, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- National Cancer Institute (NCI)
Malaria
Trial to Evaluate the Safety and Immunogenicity of a Placental Malaria Vaccine Candidate (PRIMVAC ) in Healthy Adults
The primary objective of the study is to evaluate the safety of 3 different dosages (20µg - 50µg and 100µg) of a placental malaria vaccine candidate (PRIMVAC vaccine) adjuvanted either with Alhydrogel® or GLA-SE, and administered…
- Trial name
- PRIMALVAC (NCT02658253)
- Testing
- PRIMVAC, GLA-SE, Alhydrogel
- Where
- 2 sites in Burkina Faso, France
- Volunteers
- 68 people, healthy volunteers welcome
- Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
Advanced Cancer
Phase 1/2 Study of UI-102 in Selected Advanced Cancers
This phase 1/2 first-in-human study is designed to assess the safety and efficacy of UI-102, a TLR7/8 agonist encapsulated in a Cholesteryl Pullulan Nanoparticle.
- Trial name
- NCT07605962
- Testing
- UI-102
- Where
- 3 sites in United States
- Volunteers
- 140 people
- Sponsor
- United Immunity, co., Ltd.
Acute Heart Failure
Pharmacokinetics & Safety of Serelaxin on Top of Standard of Care Therapy in Pediatric Patients With Acute Heart Failure
The purpose of the study was to evaluate the safety, tolerability and pharmacokinetics of an intravenous infusion of serelaxin on top of standard of care therapy, in pediatric patients with acute heart failure (AHF)
- Trial name
- RELAX-PEDS-PK (NCT02151383)
- Testing
- Serelaxin
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Novartis Pharmaceuticals
Amyotrophic Lateral Sclerosis
Study of AROSOD-1 in Adult Participants With Amyotrophic Lateral Sclerosis (ALS)
In this Phase 1 adult symptomatic patients with amyotrophic lateral sclerosis (ALS) carrying a superoxide dismutase 1 (SOD1) gene mutation thought to be causative of ALS, will receive single ascending doses of ARO-SOD1…
- Trial name
- NCT05949294
- Testing
- ARO-SOD1 Injection
- Sponsor
- Arrowhead Pharmaceuticals
COPD
Study to Assess the Safety and Tolerability of Incremental Doses of QAB149 in Adults With Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD)
The purpose of this study is to determine the safety and tolerability of single doses of QAB149 up to 3000 µg delivered via a single-dose, dry powder inhaler in patients with mild to moderate COPD.
- Trial name
- NCT00129831
- Testing
- QAB149
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- Novartis
Advanced Solid Tumor
Study of SGN1 Administered Via Intratumoral Injection in Patients With Advanced Solid Tumor
Objectives: To characterize safety, tolerability, MTD and OBD of intratumoral injection of SGN1 in patients with advanced solid tumors, and to preliminarily investigate the efficacy and safety of SGN1 in specific tumor subtypes.
- Trial name
- NCT05103345
- Testing
- SGN1
- Where
- 4 sites in China, Taiwan
- Volunteers
- 70 people
- Sponsor
- Guangzhou Sinogen Pharmaceutical Co., Ltd
Advanced Solid Tumor
A Phase 1/2 Study of 7MW3711 in Advanced Solid Tumors
7MW3711 is an antibody-drug conjugate(ADC) directed to a target wildly expressed on solid tumors. This is an open-label, multicenter, phase 1/2 study to evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of 7MW3711…
- Trial name
- NCT06008366
- Testing
- 7MW3711 for injection
- Where
- China
- Volunteers
- 281 people
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults
Researchers are looking for a new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman's body is going through the menopause.
- Trial name
- NCT04981431
- Testing
- Elinzanetant (BAY3427080)
- Where
- Japan
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Bayer
Chronic Hepatitis B
A Phase 1 Study of GC1102 (Recombinant Hepatitis B Immunoglobulin) in Chronic Hepatitis B Patients
This study is SAD(Single Ascending Dose)/MAD(Multiple Ascending Dose) study to Explore the Tolerability, Safety and Pharmacokinetics/Pharmacodynamics of GC1102 (Recombinant Hepatitis B Human Immunoglobulin) in Chronic Hepatitis B…
- Trial name
- NCT02569372
- Testing
- GC1102
- Where
- South Korea
- Volunteers
- 53 people
- Sponsor
- Green Cross Corporation
Resistant or Refractory Solid Tumors
Safety, Tolerability, and Pharmacokinetics of CAL056 Mesylate in Patients With Resistant or Refractory Solid Tumors
This is a multi-center, open-label, dose-escalation, phase I study to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics of CAL056 mesylate in cancer patients with resistant or…
- Trial name
- NCT04686383
- Testing
- CAL056 mesylate
- Where
- 3 sites in United States, Taiwan
- Volunteers
- 17 people
- Sponsor
- Calgent Biotechnology Co., Ltd
Pancreatic Neoplasms
Vitamin E δ-Tocotrienol Administered to Subjects With Resectable Pancreatic Exocrine Neoplasia
The purpose of this study is to determine the safest dose of the study drug Vitamin E Delta-tocotrienol, how often it should be taken, and how well people with pancreatic tumors tolerate Vitamin E Delta-tocotrienol.
- Trial name
- NCT00985777
- Testing
- Vitamin E δ-Tocotrienol
- Where
- United States
- Volunteers
- 26 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Advanced Solid Tumor
This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary…
- Trial name
- NCT04762641
- Testing
- ABL503
- Where
- 8 sites in United States, South Korea
- Volunteers
- 100 people
- Sponsor
- ABL Bio, Inc.
Advanced Solid Tumor
A Study to Assess YH001 in Combination With Toripalimab Injection in Subjects With Advanced Solid Tumors
This is an open-label, dose-escalation study of YH001 administered intravenously (IV) in combination with Toripalimab. The study is designed to determine the safety, tolerability and maximum tolerated dose (MTD) or recommended…
- Trial name
- NCT04357756
- Testing
- YH001, Toripalimab
- Where
- 3 sites in Australia
- Volunteers
- 29 people
- Sponsor
- Eucure (Beijing) Biopharma Co., Ltd
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