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

Recruiting now · Phase 2

Conditions studied: Advanced Gastric Cancer, Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma

In brief

This is a multicenter, phase 2, open label study to evaluate safety, tolerability and efficacy of SHR2554 combined with other anti-tumor treatments in patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Key facts

Study ID

NCT07102901

Run by

Jiangsu HengRui Medicine Co., Ltd.

People needed

351

Starts

2025-09-05

Expected to finish

2027-12-01

Last updated by the study team

2025-09-10

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Presence of dysphagia or other factors impairing oral administration of SHR2554.
• Has previously been treated with any enhancer of zeste homolog inhibitors.
• Uncontrolled or significant cardiovascular disease.
• 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.
• Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
• History of known hypersensitivity to SHR2554 or excipients.
• 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.
• Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.
• Psychological, social, familial, or geographical factors that would prevent regular follow-up.

Where it is running

• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)

Full record on ClinicalTrials.gov

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