Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma
- 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.
- Short title
- Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-12-01
- First posted
- 2025-08-05
- Registry last updated
- 2025-09-10
- Primary completion date
- 2027-12-01
- Start date
- 2025-09-05
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07102901
- ClinicalTrials.gov ID
- NCT07102901
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Incidence and severity of adverse events (AEs).
Timeframe: Up to approximately 2 years.
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence and severity of serious adverse events (SAEs).
Timeframe: Up to approximately 2 years.
Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Incidence of Dose Limited Toxicity (DLT).
Timeframe: Up to Day 21.
Objective response rate (ORR) by the investigator assessment.
Timeframe: 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.
Duration of objective tumor response (DoR).
Timeframe: Approximately 24 months.
Disease control rate (DCR).
Timeframe: Approximately 24 months.
Progression-free survival (PFS).
Timeframe: Approximately 24 months.
Overall survival (OS) assessed by the investigator.
Timeframe: Approximately 24 months.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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.
- Harbin Medical University Cancer HospitalHarbin, ChinaRecruiting
- The First Affiliated Hospital of Zhengzhou UniversityZhengzhou, ChinaRecruiting
Related records
Drugs (4)
Lead sponsors (1)
Conditions (3)
- Gastric cancer Primary condition
- Gastric neoplasm
- Gastroesophageal junction adenocarcinoma