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

NCT07102901 | Recruiting Phase 2

• 1 other identifier: SHR2554-203-GC
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 2

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.

Conditions

Advanced Gastric Cancer; Metastatic Gastric Cancer; Gastroesophageal Junction Adenocarcinoma

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of adverse events (AEs).

  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).

  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).

  Up to Day 21.

• Objective response rate (ORR) by the investigator assessment.

  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 Outcomes (4)

• Duration of objective tumor response (DoR).

  Approximately 24 months.

• Disease control rate (DCR).

  Approximately 24 months.

• Progression-free survival (PFS).

  Approximately 24 months.

• Overall survival (OS) assessed by the investigator.

  Approximately 24 months.

Study Arms (4)

Treatment group A

EXPERIMENTAL

Drug: SHR2554 Tablets; Drug: SHR-A1811 Injection

Treatment group B

EXPERIMENTAL

Drug: SHR2554 Tablets; Drug: SHR-A1904 Injection

Treatment group C

EXPERIMENTAL

Drug: SHR2554 Tablets; Drug: SHR-1701 Injection

Treatment group D

EXPERIMENTAL

Drug: SHR2554 Tablets

Interventions

SHR2554 Tablets DRUG

Oral SHR2554 tablets.

Treatment group A; Treatment group B; Treatment group C; Treatment group D

SHR-A1811 Injection DRUG

SHR-A1811 for injection.

Treatment group A

SHR-A1904 Injection DRUG

SHR-A1904 for injection.

Treatment group B

SHR-1701 Injection DRUG

SHR-1701 injection

Treatment group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
• Has at least 1 measurable lesion based on investigator imaging assessment (computed tomography or magnetic resonance imaging) using RECIST v1.1 at screening.
• Is willing to provide an adequate tumor sample.
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.

You may not qualify if:

• Presence of dysphagia or other factors impairing oral administration of SHR2554.
• Has previously been treated with any enhancer of zeste homolog inhibitors.
• Uncontrolled or significant cardiovascular disease.
• 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.
• Has active autoimmune diseases requiring systemic corticosteroids/immunosuppressants.
• History of known hypersensitivity to SHR2554 or excipients.
• Evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection requiring treatment with intravenous (IV) antibiotics, antivirals, or antifungals.
• Diagnosis of other malignancies within 5 years prior to the first dose of investigational product.
• Has history of interstitial lung disease (ILD), non-infectious pneumonitis requiring systemic glucocorticoids, current suspected/confirmed ILD, or clinically significant pulmonary disease history.
• Psychological, social, familial, or geographical factors that would prevent regular follow-up.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

SHR-1701

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Botao Zhu

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 5, 2025
• Study Start: September 5, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 10, 2025

Record last verified: 2025-09

Locations

CN (2)