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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJiangsu HengRui Medicine Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SHR2554 Tablets
  • SHR-A1811 Injection
  • SHR-A1904 Injection
  • SHR-1701 Injection

Treatment groups

351 Participants
are divided into 4 treatment groups