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

Not Applicable

Not yet recruiting

• Conditions: Advanced Gastric Cancer; Metastatic Gastric Cancer; Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: SHR2554 Tablets; Drug: SHR-A1811 Injection; Drug: SHR-A1904 Injection; Drug: SHR-1701 Injection

• Registration Number: NCT07102901
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-29
• Study First Submitted QC: 2025-07-29
• Last Update Submitted: 2025-08-04
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-07
• Study Start: 2025-09-01
• Primary Completion: 2027-12
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 351

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR2554 Tablets	-
Treatment group A	SHR-A1811 Injection	-
Treatment group B	SHR2554 Tablets	-
Treatment group B	SHR-A1904 Injection	-
Treatment group C	SHR2554 Tablets	-
Treatment group C	SHR-1701 Injection	-
Treatment group D	SHR2554 Tablets	-

Primary Outcome Measures

Name	Time	Method
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 of Dose Limited Toxicity (DLT).	Up to Day 21.
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.
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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS) assessed by the investigator.	Approximately 24 months.
Duration of objective tumor response (DoR).	Approximately 24 months.
Progression-free survival (PFS).	Approximately 24 months.
Disease control rate (DCR).	Approximately 24 months.

Trial Locations

Locations (2)

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China