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

September 9, 2025 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

351

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Principal Investigator:
          • Yanqiao Zhang
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Feng Wang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group A
Drug: SHR-A1811 Injection
SHR-A1811 for injection.
Drug: SHR2554 Tablets
Oral SHR2554 tablets.
Experimental: Treatment group B
Drug: SHR2554 Tablets
Oral SHR2554 tablets.
Drug: SHR-A1904 Injection
SHR-A1904 for injection.
Experimental: Treatment group C
Drug: SHR2554 Tablets
Oral SHR2554 tablets.
Drug: SHR-1701 Injection
SHR-1701 injection
Experimental: Treatment group D
Drug: SHR2554 Tablets
Oral SHR2554 tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence and severity of adverse events (AEs).
Time Frame: Up to approximately 2 years.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs).
Time Frame: Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Up to approximately 2 years.
Incidence of Dose Limited Toxicity (DLT).
Time Frame: Up to Day 21.
Up to Day 21.
Objective response rate (ORR) by the investigator assessment.
Time Frame: 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.
Up to approximately 1 year.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

July 29, 2025

First Submitted That Met QC Criteria

July 29, 2025

First Posted (Actual)

August 5, 2025

Study Record Updates

Last Update Posted (Estimated)

September 10, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR2554-203-GC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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