Clinical trials: sponsored by Astellas Pharma Global Development, Inc.
Healthy Volunteer
A Study to Learn How ASP3082 is Processed in Healthy Men
Setidegrasib (ASP3082) is being developed for certain cancers. In this study, the researchers want to understand how it is processed by the body in healthy male volunteers.
- Trial name
- NCT07773129
- Testing
- 14C-labeled ASP3082
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Neurogenic Detrusor Overactivity
A Study to Learn How Effective and Safe the Drug 'Mirabegron' is and How Long it Stays in the Body of Children Aged 6 Months to Less Than 3 Years of Age With Neurogenic Detrusor Overactivity
People with neurogenic detrusor overactivity (NDO) have poor bladder control because of how their nerves to the bladder are wired. This can cause high pressure in the bladder, causing it to leak urine by accident (incontinence).
- Trial name
- NCT05621616
- Testing
- mirabegron
- Where
- 3 sites in Philippines, Poland
- Volunteers
- 7 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
A Study of Zolbetuximab (IMAB362) Plus CAPOX Compared With Placebo Plus CAPOX as First-line Treatment of Subjects With Claudin (CLDN) 18.2-positive, HER2-negative, Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma (GLOW).
Zolbetuximab is being studied in people with cancer in and around the stomach or where the food pipe (esophagus) joins the stomach, called GEJ cancer.
- Conditions
- Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Trial name
- GLOW (NCT03653507)
- Testing
- zolbetuximab, oxaliplatin, capecitabine
- Where
- 165 sites in United States, Argentina and 16 more
- Volunteers
- 507 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pancreatic Cancer, Metastatic Pancreatic Cancer
A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer
Pancreatic cancer is difficult to diagnose early. By the time people have been diagnosed, the cancer has usually spread to other parts of the body (metastatic).
- Conditions
- Pancreatic Cancer, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
- Trial name
- NCT07409272
- Testing
- Setidegrasib, Oxaliplatin, Leucovorin
- Where
- 79 sites in United States, China and 4 more
- Volunteers
- 614 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma
A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors.
- Trial name
- NCT07488676
- Testing
- ASP546C
- Where
- 21 sites in United States, Japan
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer
A Study of Zolbetuximab Given With mFOLFOX6 or CAPOX Chemotherapy in Indian Adults With Gastric Cancer
There is an unmet medical need to treat people with advanced cancer in the stomach and the junction area where the stomach joins the food pipe.
- Conditions
- Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer, Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer, Metastatic Gastric Adenocarcinoma or Cancer, Metastatic Gastroesophageal Junction (GEJ) Adenocarcinoma
- Trial name
- NCT07829757
- Testing
- Zolbetuximab, Oxaliplatin, Folinic Acid
- Volunteers
- 50 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteers, Sjögren's Syndrome
A Study to Evaluate the Effects of ASP5502 in Healthy Adults and Adults With Primary Sjögren's Syndrome
Primary Sjögren's syndrome (pSS) is a condition when the body's immune system attacks glands that produce fluids, such as the tear and saliva glands. This leads to dry eyes and a dry mouth.
- Trial name
- NCT06544642
- Testing
- ASP5502
- Where
- United States
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Urinary Bladder Neoplasms, Carcinoma in Situ
A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC)
This study will test a drug called enfortumab vedotin in participants with a type of bladder cancer called non-muscle invasive bladder cancer (NMIBC).
- Conditions
- Urinary Bladder Neoplasms, Carcinoma in Situ, Carcinoma Transitional Cell, Non-muscle Invasive Bladder Cancer
- Trial name
- NCT05014139
- Testing
- Enfortumab vedotin
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 37 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
Claudin 18.2 protein, or CLDN18.2 is a protein found on cells in the digestive system. It is also found on some tumors. Researchers are looking at ways to attack CLDN18.2 to help control tumors.
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma
- Trial name
- NCT05365581
- Testing
- ASP2138, Pembrolizumab, Oxaliplatin
- Where
- 46 sites in United States, China and 6 more
- Volunteers
- 398 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Acute Myeloid Leukemia (AML), FLT3-mutated Acute Myeloid Leukemia
A Study of Gilteritinib, Venetoclax and Azacitidine as a Combined Treatment for People Newly Diagnosed With Acute Myeloid Leukemia
People with acute myeloid leukemia (AML) are usually treated with chemotherapy. Some people with AML have a changed FLT3 gene which causes leukemia cells to grow faster.
- Trial name
- NCT05520567
- Testing
- Gilteritinib, Venetoclax, Azacitidine
- Where
- 18 sites in United States
- Volunteers
- 70 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer
A Phase 2 Study to Evaluate the Effects of ASP5541 in Participants With Prostate Cancer
Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of the main male sex hormone, testosterone in the body.
- Conditions
- Prostate Cancer, Metastatic Castration-Resistant Prostate Cancer, Metastatic Hormone Sensitive Prostate Cancer
- Trial name
- NCT07005154
- Testing
- ASP5541, Prednisone, Prednisolone
- Where
- 54 sites in United States, China and 10 more
- Volunteers
- 218 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Allergic to House Dust Mites
A Study to Assess the Safety, Tolerability and Immunological Response of ASP2390 in Adult Subjects Allergic to House Dust Mites
The purpose of this study is to evaluate the safety and tolerability of multiple ascending intradermal doses of ASP2390 in adult male and female participants allergic to house dust mites (HDM).
- Trial name
- NCT04184895
- Testing
- ASP2390
- Where
- 2 sites in Germany
- Volunteers
- 28 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pancreatic Ductal Adenocarcinoma
A Study of ASP2138 Given Before Surgery, Then Chemotherapy After Surgery, in People With Pancreatic Ductal Cancer
Some people with pancreatic ductal cancer (PDAC) have a protein called Claudin 18.2 (CLDN18.2) in their tumor. ASP2138 is thought to work by binding to CLDN18.2 and a protein on a type of immune cell called a T-cell.
- Trial name
- NCT07024615
- Testing
- ASP2138, Oxaliplatin, Leucovorin
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pharmacokinetics of Zolbetuximab, Gastric Cancer
A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer
Zolbetuximab is being studied as a treatment for people with cancer in and around the stomach or cancer where the food pipe (esophagus) joins the stomach (gastroesophageal junction cancer).
- Conditions
- Pharmacokinetics of Zolbetuximab, Gastric Cancer, Gastro-esophageal Junction (GEJ) Cancer, Pharmacokinetics of Oxaliplatin
- Trial name
- ILUSTRO (NCT03505320)
- Testing
- zolbetuximab, oxaliplatin, leucovorin
- Where
- 21 sites in United States, France and 4 more
- Volunteers
- 143 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Solid Tumor
A Study of ASP1012 in Adults With Solid Tumors
ASP1012 is a type of virus called an oncolytic virus which is used to treat some cancers. ASP1012 was changed in a laboratory to infect and kill cancer cells, leaving healthy cells alone.
- Trial name
- NCT06171178
- Testing
- ASP1012, Pembrolizumab
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Healthy Volunteer
A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults
Genes give your body instructions on how to make proteins. Proteins are needed to keep the body working properly. Many types of cancer are caused by changes in certain genes, making them faulty.
- Trial name
- NCT07395024
- Testing
- Setidegrasib, Fluconazole, Carbamazepine
- Where
- United States
- Volunteers
- 54 people, healthy volunteers welcome
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Urothelial Carcinoma
A Safety Study of Enfortumab Vedotin in Indian Adults With Urothelial Cancer
This study is for Indian adults in India who have cancer in the bladder lining (urothelial cancer). Their cancer is advanced or has spread to other parts of the body. Enfortumab vedotin is a treatment for this type of cancer.
- Trial name
- NCT06862219
- Testing
- Enfortumab Vedotin
- Where
- 15 sites in India
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Solid Tumors
A Study of ASP1570 Taken by Itself, or ASP1570 Taken Together With Either Pembrolizumab, Standard Therapies, or Both, in Adults With Solid Tumors
Immune therapies work with the body's immune system to treat a number of cancers. They work with T-cells, a type of white blood cell, to target and attack specific tumors.
- Trial name
- NCT05083481
- Testing
- ASP1570, pembrolizumab, Trifluridine + Tipiracil
- Where
- 30 sites in United States, China and 4 more
- Volunteers
- 226 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC)
XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.
This is a global, multi-center, open-label, Phase I/II first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and/or metastatic solid tumors who have failed or are…
- Conditions
- Pancreatic Adenocarcinoma Metastatic, Lung Cancer (NSCLC), Ovarian Cancer, Colorectal Cancer Metastatic
- Trial name
- NCT06792435
- Testing
- XNW27011
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Astellas Pharma Global Development, Inc.