Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Junction Adenocarcinoma | Gastroesophageal Junction Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Metastatic Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1701 Injection | Drug | — | UNRESOLVED |
| SHR2554 Tablets | Drug | — | UNRESOLVED |
| SHR-A1811 Injection | Drug | — | UNRESOLVED |
| SHR-A1904 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Treatment group A
- interventionNames
- Drug: SHR2554 Tablets
- Drug: SHR-A1811 Injection
- type
- EXPERIMENTAL
- label
- Treatment group B
- interventionNames
- Drug: SHR2554 Tablets
- Drug: SHR-A1904 Injection
- type
- EXPERIMENTAL
- label
- Treatment group C
- interventionNames
- Drug: SHR2554 Tablets
- Drug: SHR-1701 Injection
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available