NIPH Clinical Trials Search

Early-phase Study of Claudin18.2 Peptide Diagnostic Radiopharmaceuticals

Basic Information

Recruitment status	Pending
Health condition(s) or Problem(s) studied	Gastric Cancer
Date of first enrollment	01/02/2026
Target sample size	6
Countries of recruitment
Study type	Interventional
Intervention(s)	A single intravenous dose of 148 MBq (+-20%) of the investigational drug will be administered.

Outcome(s)

Primary Outcome	Safety
Secondary Outcome	Lesion-based PET positivity rate, Patient-based PET positivity rate, Pharmacokinetics, Estimated radiation dose

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include criteria	1) Histologically confirmed gastric cancer or gastroesophageal junction cancer. 2) Presence of either of the following lesions confirmed by imaging (CT or MRI): 2)-1 Distant metastatic lesion (including recurrent distant metastasis) 2)-2 Locally residual or recurrent lesion 3) Laboratory values within 28 days prior to enrollment must meet all of the following: 3)-1 Bone marrow function a. Absolute neutrophil count >= 1,000/uL b. Platelet count >= 75,000/uL c. Hemoglobin >= 7.0 g/dL 3)-2 Renal function Estimated GFR >= 30 mL/min/1.73 m2 3)-3 Liver function a. ALT < 6 x upper limit of institutional reference range b. AST < 6 x upper limit of institutional reference range c. Total bilirubin < 3 x upper limit of institutional reference range 3)-4 Cardiac function NYHA functional classification I or lower 3)-5 Respiratory status SpO2 >= 90% on room air 4) ECOG Performance Status of 0 or 1 within 28 days prior to enrollment. 5) Age >= 18 years at the time of consent. 6) Written informed consent obtained from the subject prior to participation.
Exclude criteria	1) Presence of active double (synchronous) malignancy. 2) Presence of any of the following uncontrolled infections: a. Hepatitis B virus infection b. Hepatitis C virus infection c. HIV infection d. Other systemic infections requiring treatment 3) Presence of any of the following uncontrolled conditions or diseases: Symptomatic congestive heart failure, Unstable angina, Myocardial infarction, Arrhythmia, Severe Valvular heart disease, Severe Respiratory disease 4) Presence of psychiatric disorders or psychiatric symptoms judged to make study participation difficult. 5) Pregnant women, women who may be pregnant, or breastfeeding women. 6) Inability to comply with radiation protection instructions given by investigators within the controlled area. 7) Administration, or possibility of administration, of diagnostic or therapeutic radioisotopes other than the study drug during the study period. 8) Previous administration of 64Cu-PD-29875. 9) Any other condition that the principal investigator or sub-investigator judges to make the subject unsuitable for this study.