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

ConditionsAdvanced Gastric CancerMetastatic Gastric CancerGastroesophageal 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SHR2554 Tablets

    Drug

    Oral SHR2554 tablets.

  • SHR-A1811 Injection

    Drug

    SHR-A1811 for injection.

  • SHR-A1904 Injection

    Drug

    SHR-A1904 for injection.

  • SHR-1701 Injection

    Drug

    SHR-1701 injection

Treatment groups

351 Participants
are divided into 4 treatment groups
Group A: Treatment group AExperimental treatment 2 interventions
Group B: Treatment group BExperimental treatment 2 interventions
Group C: Treatment group CExperimental treatment 2 interventions
Group D: Treatment group DExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs).

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame
Up to approximately 2 years.
2

Incidence and severity of serious adverse events (SAEs).

Incidence and severity of serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

Time frame
Up to approximately 2 years.
3

Incidence of Dose Limited Toxicity (DLT).

Time frame
Up to Day 21.
4

Objective response rate (ORR) by the investigator assessment.

Defined as percentage of participants who achieved a best overall response of complete response (CR) or partial response (PR) assessed by the investigator.

Time frame
Up to approximately 1 year.

Secondary outcomes

1

Duration of objective tumor response (DoR).

Time frame
Approximately 24 months.
2

Disease control rate (DCR).

Time frame
Approximately 24 months.
3

Progression-free survival (PFS).

Time frame
Approximately 24 months.
4

Overall survival (OS) assessed by the investigator.

Time frame
Approximately 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jiangsu HengRui Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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