Stomach Cancer Clinical Trials

• Participants provide informed consent and confirm that they are able and willing to comply with all protocol requirements.

• Participants must be ≥ 18 years and \< 80 years of age and competent to give informed consent.

• Eastern Cooperative Oncology Group performance status ≤ 2.

• Women of childbearing potential (WOCBP) must have a negative serum test at screening and a negative urine pregnancy test at the PET/CT imaging visit (Visit 2) prior to \[68Ga\]BED003 administration.

• Note: If combining screening (Visit 1) and the PET/CT imaging visit (Visit 2) into a single visit, a serum pregnancy test must be used to exclude pregnancy.

• WOCBP, and men who are sexually active with WOCBP, must agree to use a highly-effective method(s) of contraception from the PET/CT imaging visit (Day 1/Visit 2) to the safety follow-up telephone call (Day 3/Visit 3).

• Diagnosis of either CRC (confirmed by histopathology), GC (confirmed by histopathology), PDAC (confirmed by cytology or histopathology), ILC (confirmed by histopathology), or EOC (suspected or confirmed by cytology or histopathology).

• Note: Invasive breast cancer with mixed ductal/lobular histology is permitted.

• Conventional imaging performed within 8 weeks of screening (Visit 1) and no later than 24 hours before \[68Ga\]BED003 administration and available for sending to the central imaging vendor, including, at a minimum, a contrast-enhanced CT that includes the abdomen and pelvis.

• Either:

‣ Treatment-naïve with at least stage IIB disease. Available biopsy sample or scheduled biopsy or surgical resection no later than Day 42. Cytology of the primary lesion is acceptable for participants with PDAC who are not surgical candidates.

⁃ Following neoadjuvant therapy (with at least stage IIB disease at initial presentation) with scheduled biopsy or surgical resection no later than Day 42.

⁃ Suspected recurrence after definitive therapy.