Actively Recruiting
A Phase 1/1b Study of ASP2138 Alone and With Pembrolizumab and mFOLFOX6 or Ramucirumab and Paclitaxel in Advanced Gastric, Gastroesophageal Junction, or Pancreatic Cancer With CLDN18.2 Expression
Led by Astellas Pharma Global Development, Inc. · Updated on 2026-05-28
398
Participants Needed
46
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying ASP2138, a potential treatment targeting the claudin 18.2 protein found on digestive system cells and some tumors. This study focuses on adults with stomach cancer, gastroesophageal junction (GEJ) cancer, or pancreatic cancer that is locally advanced unresectable or metastatic, and whose tumors express the CLDN18.2 marker. The trial aims to understand how ASP2138 is processed by the body and its effects when given alone or with standard cancer treatments, including pembrolizumab with mFOLFOX6, ramucirumab with paclitaxel, and mFOLFIRINOX, depending on the cancer type. The trial includes a Phase 1 dose escalation study where small groups receive increasing doses of ASP2138 either intravenously or subcutaneously, alone or combined with standard treatments based on cancer type. Following dose determination, a Phase 1b expansion phase administers the selected doses of ASP2138 alone or in combination with standard therapies. The treatments are given according to participants' specific cancers and treatment history. An end-of-treatment visit occurs 7 days after the final dose or if the doctor stops treatment earlier. Notably, participants with locally advanced unresectable pancreatic cancer will not receive ASP2138 alone. Participants will undergo regular evaluations including safety checks for side effects, laboratory tests, vital signs, ECGs, and physical exams over up to 27 months. Researchers will monitor dose-limiting toxicities, adverse events, and overall response rates using imaging criteria. Tumor markers and expression levels of CLDN18.2 and PD-L1 will be assessed. Participants will be followed for safety and treatment effects throughout the study period, which helps determine suitable dosing and potential treatment impacts.
CONDITIONS
Brief Title
A Study of ASP2138 Given by Itself or Given With Other Cancer Treatments in Adults With Stomach Cancer, Gastroesophageal Junction Cancer, or Pancreatic Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult participant according to local regulations at consent signing
- Female participants must not be pregnant and agree to contraceptive guidance and breastfeeding restrictions
- Male participants with female partners of childbearing potential must agree to use contraception
- Tumor sample positive for claudin 18.2 (CLDN18.2) expression
- Radiographically confirmed locally advanced, unresectable or metastatic disease within 28 days prior to first dose
- At least 1 measurable lesion per RECIST 1.1 within 28 days prior to first dose
- QTcF interval ≤ 470 msec
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Predicted life expectancy of 12 weeks or more
- Meet laboratory test criteria within 7 days prior to first dose
- Specific disease criteria for gastric/GEJ or pancreatic cancer depending on study arm
- Agree not to participate in another interventional study during this trial
You will not qualify if you...
- Received other investigational agents or antineoplastic therapy within 21 days or 5 half-lives before first dose
- Any condition making participant unsuitable for study
- Known hypersensitivity or severe allergic reaction to study components
- Body weight under 40 kg
- Recent systemic immunosuppressive therapy (except certain corticosteroid uses)
- Complete or partial gastric outlet syndrome with persistent vomiting
- Significant gastric bleeding or untreated gastric ulcers
- Symptomatic or unstable CNS metastases
- Known HIV infection with CD4+ count under 350 or recent AIDS-defining infections
- Active hepatitis B or C infection
- Recent serious cardiac events within 6 months
- Active infection requiring systemic therapy not resolved within 7 days
- Active autoimmune disease requiring recent immunosuppressive treatment
- Significant comorbidities or psychiatric illness affecting compliance
- Major surgery within 28 days without full recovery
- Recent radiotherapy without recovery from toxicity
- Concurrent other malignancy requiring treatment
- Prior CLDN18.2-targeted therapy within specified time unless in expansion cohorts
- History or complication of interstitial lung disease
- Specific exclusions for combination therapy arms including immunodeficiency, uncontrolled hypertension, bleeding disorders, and prior severe allergic reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 28 days
Participants enroll in a dose escalation phase where ASP2138 is given alone or in combination with other cancer treatments to determine the maximum tolerated dose and recommended phase 2 dose.
Repeated visits during dose escalation period
Duration - Up to 27 months
Participants receive ASP2138 alone or in combination with pembrolizumab and mFOLFOX6, ramucirumab and paclitaxel, or mFOLFIRINOX according to their assigned dose expansion cohort to treat advanced gastric, gastroesophageal junction, or pancreatic cancer.
Regular visits for treatment administration and assessments over months
Duration - Up to 27 months
Participants are monitored for safety, response to treatment, and any adverse events after completion or discontinuation of treatment.
Periodic visits for safety and efficacy assessments
Trial Site Locations
Total: 46 locations
1
University of California Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
2
UCLA Dept of Medicine - Hematology/Oncology, Santa Monica
Santa Monica, California, United States, 90404
Withdrawn
3
Northwestern University
Chicago, Illinois, United States, 60611
Actively Recruiting
4
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
5
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08901
Completed
6
NYU Langone Medical Center - NYU Medical Oncology Associates
New York, New York, United States, 10016
Actively Recruiting
7
Columbia University
New York, New York, United States, 10032
Active, Not Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Duke Children's Hospital and Health Center
Durham, North Carolina, United States, 27710
Actively Recruiting
10
Wake Forest University Baptist Health
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
11
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
12
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Actively Recruiting
13
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
14
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Actively Recruiting
15
Henan Cancer Hospital
Zhengzhou, Henan, China
Actively Recruiting
16
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
17
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Actively Recruiting
18
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
19
Site FR33005
Vaillant, Villejuif, France
Actively Recruiting
20
Site FR33003
Lyon, France
Actively Recruiting
21
Site FR33004
Marseille, France
Actively Recruiting
22
Site FR33006
Poitiers, France
Actively Recruiting
23
Site FR33001
Saint-Herblain, France
Actively Recruiting
24
Site FR33002
Toulouse, France
Actively Recruiting
25
Site IT39004
Milan, Italy
Actively Recruiting
26
Site IT39001
Milan, Italy
Actively Recruiting
27
Site IT39005
Rozzano, Italy
Actively Recruiting
28
Site IT39003
Verona, Italy
Actively Recruiting
29
Aichi Cancer Center
Nagoya, Aichi-ken, Japan
Actively Recruiting
30
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Actively Recruiting
31
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Actively Recruiting
32
Kindai University Hospital
Sakai, Osaka, Japan
Actively Recruiting
33
The University of Osaka Hospital
Suita, Osaka, Japan
Actively Recruiting
34
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Completed
35
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo, Japan
Actively Recruiting
36
PanOncology Trials
San Juan, Puerto Rico
Actively Recruiting
37
Site KR82004
Seongnam-si, Gyeonggi-do, South Korea
Actively Recruiting
38
Site KR82001
Guro-gu, Seoul, South Korea
Actively Recruiting
39
Site KR82002
Jongno-gu, Seoul, South Korea
Actively Recruiting
40
Site KR82003
Seocho-gu, Seoul, South Korea
Actively Recruiting
41
Site KR82005
Seodaemun-gu, Seoul, South Korea
Actively Recruiting
42
Site ES34001
Barcelona, Spain
Actively Recruiting
43
Site ES34002
Barcelona, Spain
Actively Recruiting
44
Site ES34006
Barcelona, Spain
Actively Recruiting
45
Site ES34007
El Palmar, Spain
Actively Recruiting
46
Site ES34004
Zaragoza, Spain
Actively Recruiting
Research Team
A
Astellas Pharma Global Development, Inc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here