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Recruiting Phase 2

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

NCT07102901 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-09-05
Last updated
2025-09-10

Condition(s) studied

Advanced Gastric CancerMetastatic Gastric CancerGastroesophageal Junction Adenocarcinoma

Investigational drug(s) / intervention(s)

SHR2554 Tablets →SHR-A1811 Injection →SHR-A1904 Injection →SHR-1701 Injection →

SHR2554 Tablets: Oral SHR2554 tablets.

SHR-A1811 Injection: SHR-A1811 for injection.

SHR-A1904 Injection: SHR-A1904 for injection.

SHR-1701 Injection: SHR-1701 injection

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence and severity of adverse events (AEs). — Up to approximately 2 years.
    Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
  • Incidence and severity of serious adverse events (SAEs). — Up to approximately 2 years.
    Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
  • Incidence of Dose Limited Toxicity (DLT). — Up to Day 21.
  • Objective response rate (ORR) by the investigator assessment. — Up to approximately 1 year.
    Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator.

Trial sites (2)

FacilityCityRegionStatus
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07102901 on ClinicalTrials.gov ↗ ← All trials in China