Recruiting NCT07102901
Safety and Efficacy of SHR2554 Combined With Other Antitumor Therapies in Gastric or Gastro-oesophageal Junction Adenocarcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR2554 Tablets, SHR-A1811 Injection, SHR-A1904 Injection, SHR-1701 Injection.
- Who it may be relevant to
- Registry conditions: Advanced Gastric Cancer, Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug SHR2554 Tablets
Oral SHR2554 tablets. - Drug SHR-A1811 Injection
SHR-A1811 for injection. - Drug SHR-A1904 Injection
SHR-A1904 for injection. - Drug SHR-1701 Injection
SHR-1701 injection
Primary outcome measures
- Incidence and severity of adverse events (AEs). [Time frame: Up to approximately 2 years.]
- Incidence and severity of serious adverse events (SAEs). [Time frame: Up to approximately 2 years.]
- Incidence of Dose Limited Toxicity (DLT). [Time frame: Up to Day 21.]
- Objective response rate (ORR) by the investigator assessment. [Time frame: Up to approximately 1 year.]
Secondary outcome measures (4)
- Duration of objective tumor response (DoR). [Time frame: Approximately 24 months.]
- Disease control rate (DCR). [Time frame: Approximately 24 months.]
- Progression-free survival (PFS). [Time frame: Approximately 24 months.]
- Overall survival (OS) assessed by the investigator. [Time frame: Approximately 24 months.]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Harbin Medical University Cancer Hospital — Harbin
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou
Identifiers
NCT: NCT07102901 · SHR2554-203-GC