A Study of ASP2138 in Adults With Stomach Cancer or Pancreatic Cancer

• Status: Not yet recruiting
• Trial end date: 2026-01-31
• Target enrollment: 0
• Participant gender: All

Summary

ASP2138 is a potential new treatment for people with stomach cancer, gastroesophageal junction cancer, or pancreatic cancer. Before ASP2138 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. They do this to find a suitable dose and to check for potential medical problems from the treatment.

People who are 18 years or older can take part. This is an open-label study. This means that people in this study will know that they will receive ASP2138.

The study will have 2 phases. Phase 1 is called dose escalation. Different small groups of people will take lower to higher doses of ASP2138. Medical problems will be recorded at each dose. This is done to find suitable doses of ASP2138 to use later in the study. Doctors will also check how each type of cancer is responding to ASP2138.

Phase 1b is called dose expansion. Other different small groups will take part, and will take suitable doses of ASP2138 found from phase 1. This phase will check how each type of cancer responds to ASP2138. The response to ASP2138 is measured using x-rays, scans and blood tests. Doctors will continue to check all medical problems throughout the study.

ASP2138 will be given through a vein in the arm. This is called an infusion. People will continue to receive treatment until: their disease gets worse; they have medical problems they can't tolerate; they ask to stop treatment; the doctors decide that continuing treatment is no longer in that person's best interest; the study is ended by the sponsor. Study doctors will check for any medical problems from ASP2138. Other checks will include physical exams, checking the nervous system, laboratory tests and vital signs. Nervous system checks include checking reflexes, balance, movement and muscle strength. Vital signs include body temperature, blood pressure and pulse. Electrocardiograms (ECG) will be done to check the heart rhythm during the study. People will receive ASP2138 in a hospital. They will give blood samples and study doctors will check for medical problems. People will also visit the clinic on certain days during their treatment, with extra visits during the first 3 cycles of treatment.

People will visit the clinic after treatment has finished. The study doctors will check for more medical problems. Other checks will include physical exams, laboratory tests and vital signs. People will also have an ECG.

After this, people will visit the clinic for a check-up several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.

Criteria

Inclusion Criteria:

• Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF).

• Female participant is not pregnant, confirmed by serum pregnancy test and medical evaluation by interview and at least 1 of the following conditions apply:

• Not a woman of childbearing potential (WOCBP)

• WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final investigational product (IP) administration.

• Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after the final IP administration.

• Female participant must not donate ova starting at screening and throughout the study period and for 6 months after the final IP administration.

• Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 6 months after the final IP administration.

• Male participant must not donate sperm during the treatment period and for 6 months after the final IP administration.

• Male participant with pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the study period and for 6 months after the final IP administration.

• Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing.

• Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of IP.

• Participant has measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of IP. For participant with only 1 measurable lesion and prior radiotherapy, the lesion must be outside the field of prior radiotherapy or must have documented progression following radiation therapy.

• Participant has symptomatic central nervous system (CNS) metastases or participant has evidence of unstable CNS metastases even if asymptomatic (e.g., progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for no longer than 2 weeks.

• Participant has QT interval by Fredericia (QTcF) ≤ 470 msec.

• Participant agrees not to participate in another interventional study while receiving study treatment in the present study.

• Participant has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Participant has predicted life expectancy ≥ 12 weeks.

• Participant must meet all of criteria based on laboratory tests within 7 days prior to the first dose of study drug. In case of multiple laboratory data within this period, the most recent data should be used. If a participant has received a recent blood transfusion, the laboratory tests must be obtained ≥ 4 weeks after any blood transfusion.

Disease Specific Criteria: Gastric/GEJ Cancer

• Participant has histologically confirmed gastric or gastroesophageal junction (GEJ) adenocarcinoma.

• Participant with gastric or GEJ adenocarcinoma must have progressed after receiving standard of care approved therapies or be no longer eligible for standard therapy (no limit to the number or prior treatment regimens) including fluoropyrimidine and platinum containing chemotherapy, and if appropriate, immune checkpoint inhibitor and human epidermal growth factor receptor 2 (HER2)/neu-targeted therapy. Participants for whom platinum-containing chemotherapy is contraindicated or who refuse such treatment are also allowed in the study.

Disease Specific Criteria: Pancreatic Cancer

• Participant has histologically or cytologically confirmed pancreatic adenocarcinoma.

• Participant with pancreatic adenocarcinoma must have progressed after receiving standard of care approved therapies or be no longer eligible for standard therapy (no limit to the number or prior treatment regimens).

Exclusion Criteria:

• Participant has received other investigational agents or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of IP administration.

• Participant has any condition which makes the participant unsuitable for study participation.

• Participant has known immediate or delayed hypersensitivity or contraindication to any component of study treatment.

• Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies.

• Participant weighs < 40 kg.

• Participant has received systemic immunosuppressive therapy, including systemic corticosteroids 14 days prior to first dose of IP. Participant using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone or up to 10 mg per day of prednisone), receiving a single daily dose of systemic corticosteroids or receiving systemic corticosteroids as pre-medication for radiologic imaging contrast use are allowed.

• Participant has a complete gastric outlet syndrome or a partial gastric outlet syndrome with persistent/recurrent vomiting.

• Participant has significant gastric bleeding and/or untreated gastric ulcers that exclude the participant from participation.

• Participant has history of central nervous system metastases and/or carcinomatous meningitis from gastric/GEJ or pancreatic cancer.

• Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts ≥ 350 cells/µL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. NOTE: Screening for human immunodeficiency virus (HIV) infection should be conducted per local requirements.

• Participant is known to have active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. NOTE: Screening for these infections should be conducted per local requirements.

• For participant who is negative for HBsAg, but hepatitis B core antibody (HBc Ab) positive, a hepatitis B virus (HBV) deoxyribonucleic acid (DNA) test will be performed and if positive the participant will be excluded.

• Participant with positive hepatitis C virus (HCV) serology, but negative HCV ribonucleic acid (RNA) test results are eligible.

• Participant treated for HCV with undetectable viral load results are eligible

• Participant has had within 6 months prior to first dose of IP any of the following:

unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure.

• Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of IP.

• Participant has active autoimmune disease that has required systemic immunosuppressive treatment within the past 1 month prior to the start of IP.

• Participant has a clinically significant disease or co-morbidity that may adversely affect the safe delivery of treatment within this study or make the participant unsuitable for study participation.

• Participant has psychiatric illness or social situations that would preclude study compliance.

• Participant has had a major surgical procedure 28 days before start of IP.

• Participant is without complete recovery from a major surgical procedure 14 days before start of IP.

• Participant has received radiotherapy for locally advanced unresectable or metastatic gastric or GEJ or metastatic pancreatic adenocarcinoma 14 days prior to start of IP and has NOT recovered from any related toxicity.

• Participant has another malignancy for which treatment is required.

• Participant who has received an CLDN18.2-targeted investigational agent (e.g., zolbetuximab or chimeric antigen receptor CLDN18.2-specific T cells) prior to first dose of IP administration is not eligible for dose escalation cohorts. However, a participant who has received an CLDN18.2-targeted investigational agent greater than 28 days or 5 half-lives (whichever is longer) prior to first dose IP administration is eligible for dose expansion cohorts only, with the exception of subjects who have experienced Grade ≥ 3 gastrointestinal (GI) toxicity after receiving an CLDN18.2-targeted investigational agent.

• Participant has a history or complication of interstitial lung disease.