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Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT07102901•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.

Locations (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Key Dates

Start Date

September 5, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

September 10, 2025

Enrollment

351

ESTIMATED participants

Conditions

Advanced Gastric CancerMetastatic Gastric CancerGastroesophageal Junction Adenocarcinoma

Interventions

SHR2554 Tablets

DRUG

SHR-A1811 Injection

DRUG

SHR-A1904 Injection

DRUG

SHR-1701 Injection

DRUG

Contacts

Botao Zhu

CONTACT

+86-021-23511999 botao.zhu.bz19@hengrui.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 10, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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