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

A Multicenter, Open-Label Phase II Clinical Study Evaluating the Safety, Tolerability and Efficacy of SHR2554 Tablets in Combination With Other Antitumor Therapies in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastro-oesophageal Junction Adenocarcinoma

This study will test if adding SHR2554 to other anti-cancer treatments helps people with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 351 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry-sponsored)
• Locations: 2 sites (Harbin, Heilongjiang and 1 other locations)
• Trial ID: NCT07102901 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have at least one measurable lesion, ECOG 0–1, can take oral medication, and can provide a tumor sample are the intended participants.

Not a fit: Patients who cannot swallow oral medication, have prior EZH inhibitor exposure, untreated symptomatic brain metastases, uncontrolled cardiovascular disease, or active autoimmune disease requiring systemic immunosuppression are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the combination could improve tumor control and potentially extend progression-free survival for some patients with advanced gastric or gastroesophageal junction adenocarcinoma.

How similar studies have performed: Combinations involving EZH2-targeting agents and other anti-tumor therapies are experimental in solid tumors and have shown limited and mixed clinical success so far, so this approach remains exploratory.

Eligibility criteria

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 this trial is running

Harbin, Heilongjiang and 1 other locations

• 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

Conditions Advanced Gastric Cancer; Metastatic Gastric Cancer; Gastroesophageal Junction Adenocarcinoma