SHR2554 combined with other cancer medicines for advanced stomach or gastroesophageal junction adenocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label phase 2 study in China tests the safety, tolerability, and anti-tumor activity of the oral agent SHR2554 given in combination with other anti-cancer injections (SHR-A1811, SHR-A1904, SHR-1701) in adults with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. Eligible patients must have at least one measurable lesion per RECIST v1.1, an ECOG performance status of 0–1, and be willing to provide an adequate tumor sample. Key exclusions include inability to take oral medication (for example severe dysphagia), prior treatment with EZH inhibitors, uncontrolled cardiovascular disease, active autoimmune disease requiring systemic immunosuppression, and untreated symptomatic CNS metastases. The trial's primary focus is safety and tolerability with secondary efficacy endpoints such as objective response rate and progression-free survival, with treatment and follow-up at participating centers in Harbin and Zhengzhou.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of dysphagia or other factors impairing oral administration of SHR2554.
2. Has previously been treated with any enhancer of zeste homolog inhibitors.
3. Uncontrolled or significant cardiovascular disease.
4. 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.
5. Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
6. History of known hypersensitivity to SHR2554 or excipients.
7. Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.
8. Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.
9. Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.
10. Psychological, social, familial, or geographical factors that would prevent regular follow-up.

Where it's running

• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Recruiting
• The First Affiliated Hospital of Zhengzhou University
  Zhengzhou, Henan, China Recruiting

Study contacts

• Study coordinator: Botao Zhu
• Email: botao.zhu.bz19@hengrui.com
• Phone: +86-021-23511999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.