Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Pancreatic Adenocarcinoma
Conditions
Interventions
The study will have 2 phases.
In Phase 1, different small groups of people will receive lower to higher doses of ASP2138 given by itself or together with the standard cancer treatments. Any medical p
Sponsors
Lee Paul
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Criteria 1. Participant is considered an adult according to local regulation at the time of signing the informed consent form (ICF). 2. Female participant is not pregnant, confirmed by serum pregnancy test and medical evaluation by interview and at least 1 of the following conditions apply: a. Not a woman of childbearing potential (WOCBP) b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final study intervention administration. 3. Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after the final study intervention administration. 4. Female participant must not donate ova starting at screening and throughout the study period and for 6 months after the final study intervention administration. 5. 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 study intervention administration. 6. Male participant must not donate sperm during the treatment period and for 6 months after the final study intervention administration. 7. 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 study intervention administration. 8. Participant's tumor sample is positive for claudin (CLDN)18.2 expression by central immunohistochemistry (IHC) testing. 9. Participant has radiographically-confirmed, locally advanced, unresectable or metastatic disease within 28 days prior to the first dose of study intervention . 10. Participant has at least 1 measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 within 28 days prior to the first dose of study intervention. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions. 11. Participant has QT interval by Fredericia (QTcF) == 12 weeks. 15. Participant must meet all criteria based on laboratory tests within 7 days prior to the first dose of study intervention. 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 >= 1 week after any blood transfusion. Monotherapy Disease specific Criteria: Gastric/GEJ Cancer 1. Participant has histologically confirmed metastatic, locally advanced unresectable gastric/ gastroesophageal junction (GEJ) adenocarcinoma. 2. Escalation: Participant with gastric/ GEJ adenocarcinoma who has progressed, is intolerant, has refused, or for whom there is no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens). 3. Expansion: Participant with gastric/ GEJ adenocarcinoma must have received no more than 3 prior lines of systemic chemotherapy treatment. Monotherapy Disease specific Criteria: Pancreatic Cancer 1. Participant has histologically or cytologic
Exclusion criteria
Exclusion criteria: 1. Participant has received other investigational agents, or antineoplastic therapy including other immunotherapy or devices concurrently or within 21 days or 5 times the half-life, whichever is shorter, prior to first dose of study intervention administration. 2. Participant has any condition, which makes the participant unsuitable for study intervention. 3. Participant has known immediate or delayed hypersensitivity or contraindication to any component of study intervention. 4. Participant has had prior severe allergic reaction or intolerance to known ingredients of ASP2138 or other antibodies, including humanized or chimeric antibodies. 5. Participant weighs 10 mg per day of prednisone or equivalent) for no longer than 2 weeks. 10. Participant is known to have HIV infection. However, participants with cluster of differentiation (CD4) + T cell counts >= 350 cells/microL 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. 11. Participant is known to have active hepatitis B (positive hepatitis B surface antigen [HBsAg]) or hepatitis C infection. Testing is required for known history of these infections or as mandated by local requirements. 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 12. Participant has had within 6 months prior to first dose of study intervention any of the following: unstable angina, myocardial infarction, ventricular arrhythmia requiring intervention or hospitalization for heart failure. 13. Participant has active infection requiring systemic therapy that has not completely resolved within 7 days prior to the start of study intervention. 14. Participant has active autoimmune disease that has required systemic immunosup
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Dose-limiting toxicities -Adverse events / serious adverse events -Clinical laboratory tests -Vital signs -Electrocardiogram -Physical examination -ECOG performance status | — |
Secondary
| Measure | Time frame |
|---|---|
| -Pharmacokinetic parameters of ASP2138: AUCtau, Cmax, Ctrough and tmax (as applicable) -Overall response rate (ORR) and disease control rate (DCR) by RECIST 1.1 -Serum carbohydrate antigen 19-9 (CA19-9) (pancreatic cancer only) -CLDN 18.2 tumor expression -PD-L1 tumor expression | — |
Countries
China, France, Italy, Japan, Puerto Rico, South Korea, Spain, United States
Contacts
Public ContactInformation Center Medical
Astellas Pharma Inc.
Outcome results
None listed