Advanced Gastric Cancer, Metastatic Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
Conditions
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.
Interventions
DRUGSHR-A1904 Injection
SHR-A1904 for injection.
SHR-1701 injection
DRUGSHR2554 Tablets
Oral SHR2554 tablets.
SHR-A1811 for injection.
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) by the investigator assessment. | 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. |
| Incidence and severity of adverse events (AEs). | 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). | 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). | Up to Day 21. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. |
Countries
China
Contacts
Primary ContactBotao Zhu
Outcome results
None listed