RecruitingPhase 2NCT07102901

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


Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Enrollment

351 participants

Start Date

Sep 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria10

  • 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.

Interventions

DRUGSHR2554 Tablets

Oral SHR2554 tablets.

DRUGSHR-A1811 Injection

SHR-A1811 for injection.

DRUGSHR-A1904 Injection

SHR-A1904 for injection.

DRUGSHR-1701 Injection

SHR-1701 injection


Locations(2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07102901


Related Trials