Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma

Prior treatment

• Has previously been treated with any enhancer of zeste homolog inhibitors.
• Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
• Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.
• Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.

Other illness

• Uncontrolled or significant cardiovascular disease.
• Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
• History of known hypersensitivity to SHR2554 or excipients.
• Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.

Other

• Presence of dysphagia or other factors impairing oral administration of SHR2554.
• Psychological, social, familial, or geographical factors that would prevent regular follow-up.

• At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
• Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.
• Is willing to provide an adequate tumor sample.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.