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

Hengrui Medicine

Status and phase: Enrolling; Phase 2

Conditions: Metastatic Gastric Cancer; Gastroesophageal Junction Adenocarcinoma; Advanced Gastric Cancer

Treatments: Drug: SHR2554 Tablets; Drug: SHR-1701 Injection; Drug: SHR-A1904 Injection; Drug: SHR-A1811 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07102901

SHR2554-203-GC

Details and patient eligibility

About

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.

Enrollment: 351 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

351 participants in 4 patient groups

Treatment group A

Experimental group

Treatment:

Drug: SHR-A1811 Injection

Drug: SHR2554 Tablets

Treatment group B

Experimental group

Treatment:

Drug: SHR-A1904 Injection

Drug: SHR2554 Tablets

Treatment group C

Experimental group

Treatment:

Drug: SHR-1701 Injection

Drug: SHR2554 Tablets

Treatment group D

Experimental group

Treatment:

Drug: SHR2554 Tablets