RecruitingPhase 1NCT05365581

A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer

A Phase 1/1b Study of ASP2138 as Monotherapy and in Combination With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Participants With Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma and in Combination With mFOLFIRINOX in Participants With Metastatic or Locally Advanced Unresectable Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression


Sponsor

Astellas Pharma Global Development, Inc.

Enrollment

398 participants

Start Date

Jun 7, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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. ASP2138 is thought to bind to CLDN18.2 and a protein on a type of immune cell called a T-cell. This "tells" the immune system to attack the tumor. ASP2138 is a potential treatment for people with stomach cancer, gastroesophageal junction cancer (GEJ cancer) or pancreatic cancer. GEJ is where the tube that carries food (esophagus) joins the stomach. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. In this study, ASP2138 will either be given by itself, or given together with standard treatments for gastric, GEJ and pancreatic cancer. Pembrolizumab and mFOLFOX6, and ramucirumab and paclitaxel are standard treatments for gastric and GEJ cancer. mFOLFIRINOX is a standard treatment for pancreatic cancer. This information will help find a suitable dose of ASP2138 given by itself and together with the standard cancer treatments and to check for potential medical problems from the treatments. The main aims of the study are: * To check the safety of ASP2138 and how well people can tolerate medical problems during the study. * To find a suitable dose of ASP2138 to be used later in the study. * These are done for ASP2138 given by itself and when given together with the standard cancer treatments. Adults 18 years or older with stomach cancer, GEJ cancer, or pancreatic cancer can take part. Their cancer is locally advanced unresectable or metastatic. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. There should also be the CLDN18.2 marker in a tumor sample. People cannot take part if they need to take medicines to suppress their immune system, have blockages or bleeding in their gut, have specific uncontrollable cancers, have specific infections, have a condition such as hemophagocytic lymphohistiocytosis (HLH) which is when the body over-reacts to a "trigger" such as infection, or have a specific heart condition ("New York Heart Association Class III or IV"). Phase 1: Lower to higher doses of ASP2138 * ASP2138 is either given through a vein (intravenous infusion) or just under the skin (subcutaneous injection). * Different small groups are given lower to higher doses of ASAP2138. * ASP2138 is either given by itself, or given with 1 of 3 standard treatments: * Pembrolizumab and mFOLFOX6 (first treatment for gastric GEJ cancer) * Ramacirumab and paclitaxel (Second treatment for gastric or GEJ cancer) * ASP2138 with mFOLFIRINOX (first treatment for pancreatic cancer) Phase 1b: doses of ASP2138 worked out from Phase 1 * ASP2138 is either given through a vein or just under the skin. This depends on the findings from Phase 1. * People with gastric cancer, GEJ cancer or pancreatic cancer are given doses of ASP2138, worked out from Phase 1. * This includes doses of ASP2138 given by itself and ASP2138 given with the standard cancer treatments. * The standard cancer treatments given depends on the type of cancer they have. End of treatment visit: This is 7 days after final dose of study treatment or if the study doctor decides to stop the person's treatment. People who have locally advanced unresectable pancreatic cancer will not receive ASP2138 by itself.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer drug called ASP2138, alone or combined with standard chemotherapy and immunotherapy, for adults with advanced stomach cancer, cancer at the junction of the stomach and esophagus, or pancreatic cancer. The drug targets a protein called claudin 18.2 that is found on some of these cancer cells. **You may be eligible if...** - You are an adult with advanced or metastatic stomach, gastroesophageal junction, or pancreatic cancer - Your tumor tests positive for the claudin 18.2 protein - Your cancer has progressed despite previous treatment, or no standard treatment is available - You are in reasonably good health (able to carry out daily activities) - You have measurable disease on imaging **You may NOT be eligible if...** - You are pregnant, breastfeeding, or not using contraception - You weigh less than 40 kg (about 88 lbs) - You have active HIV, hepatitis B, or hepatitis C infection - You have had a serious heart event (heart attack, heart failure) within the past 6 months - You have an active or serious infection - You have had major surgery within the past 28 days - You have a severe autoimmune disease requiring treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGASP2138

Intravenously or Subcutaneously

DRUGPembrolizumab

Intravenously

DRUGOxaliplatin

Intravenously

DRUGLeucovorin

Intravenously

DRUGFluorouracil

Intravenously

DRUGRamucirumab

Intravenously

DRUGPaclitaxel

Intravenously

DRUGIrinotecan

Intravenously

DRUGCapecitabine

Oral Administration


Locations(45)

University of California Irvine Medical Center

Orange, California, United States

UCLA Dept of Medicine - Hematology/Oncology, Santa Monica

Santa Monica, California, United States

Northwestern University

Chicago, Illinois, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, United States

NYU Langone Medical Center - NYU Medical Oncology Associates

New York, New York, United States

Columbia University

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke Children's Hospital and Health Center

Durham, North Carolina, United States

Wake Forest University Baptist Health

Winston-Salem, North Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital, College of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site FR33005

Vaillant, Villejuif, France

Site FR33003

Lyon, France

Site FR33004

Marseille, France

Site FR33006

Poitiers, France

Site FR33001

Saint-Herblain, France

Site FR33002

Toulouse, France

Site IT39004

Milan, Italy

Site IT39001

Milan, Italy

Site IT39005

Rozzano, Italy

Site IT39003

Verona, Italy

Aichi Cancer Center

Nagoya, Aichi-ken, Japan

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Kindai University Hospital

Sakai, Osaka, Japan

The University of Osaka Hospital

Suita, Osaka, Japan

National Cancer Center Hospital

Chuo-ku, Tokyo, Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koto-ku, Tokyo, Japan

PanOncology Trials

San Juan, Puerto Rico

Site KR82004

Seongnam-si, Gyeonggi-do, South Korea

Site KR82001

Guro-gu, Seoul, South Korea

Site KR82002

Jongno-gu, Seoul, South Korea

Site KR82003

Seocho-gu, Seoul, South Korea

Site KR82005

Seodaemun-gu, Seoul, South Korea

Site ES34001

Barcelona, Spain

Site ES34002

Barcelona, Spain

Site ES34007

El Palmar, Spain

Site ES34004

Zaragoza, Spain

View Full Details on ClinicalTrials.gov

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NCT05365581


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