Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer

NCT ID: NCT05671822

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-14
• Study Completion Date: 2026-07-30

Brief Summary

This is an open,multicentre phase Ib/II study. The purpose of phase Ib is to evaluated the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with chemotherapy and/or immunotherapy in HER2 expression advanced/metastatic gastric/gastroesophageal junction adenocarcinoma patients.

The Phase II study was designed to evaluate the efficacy and safety of SHR-A1811 in combination with chemotherapy and/or immunotherapy for advanced/metastatic HER2 expression gastric/gastroesophageal conjunctional adenocarcinoma patients.

Conditions

HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1A: SHR-A1811 and SHR-1701

Group Type: EXPERIMENTAL

SHR-A1811 and SHR-1701

Intervention Type: DRUG

(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;

Arm 1B: SHR-A1811 and capecitabine

Group Type: EXPERIMENTAL

SHR-A1811 and capecitabine

Intervention Type: DRUG

(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

Arm 1C: SHR-A181, SHR-1701, and capecitabine

Group Type: EXPERIMENTAL

SHR-A181, SHR-1701, and capecitabine

Intervention Type: DRUG

(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；

Arm 1D: SHR-A1811, SHR-1316, and capecitabine

Group Type: EXPERIMENTAL

SHR-A1811, SHR-1316, and capecitabine

Intervention Type: DRUG

(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；

Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

Group Type: EXPERIMENTAL

SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

Intervention Type: DRUG

(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

Arm 1G: SHR-A1811, SHR-1316, and 5-FU

Group Type: EXPERIMENTAL

SHR-A1811, SHR-1316, and 5-FU

Intervention Type: DRUG

(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Arm 2A: SHR-A1811, SHR-1316, and capecitabine

Group Type: EXPERIMENTAL

SHR-A1811, SHR-1316, and capecitabine

Intervention Type: DRUG

(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；

Arm 2B: SHR-1316 and SHR-A181

Group Type: EXPERIMENTAL

SHR-1316 and SHR-A1811

Intervention Type: DRUG

(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion

Arm 2C: SHR-A1811 and capecitabine

Group Type: EXPERIMENTAL

SHR-A1811 and capecitabine

Intervention Type: DRUG

(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

Arm 2D: SHR-A1811, SHR-1316, and 5-FU

Group Type: EXPERIMENTAL

SHR-A1811, SHR-1316, and 5-FU

Intervention Type: DRUG

(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Arm 2E: SHR-A1811and 5-FU

Group Type: EXPERIMENTAL

SHR-A1811and 5-FU

Intervention Type: DRUG

(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

Group Type: EXPERIMENTAL

SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

Intervention Type: DRUG

(Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

Interventions

SHR-A1811 and SHR-1701

(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion;

Intervention Type: DRUG

SHR-A1811 and capecitabine

(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

Intervention Type: DRUG

SHR-A181, SHR-1701, and capecitabine

(Arm 1C) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered orally；

Intervention Type: DRUG

SHR-A1811, SHR-1316, and capecitabine

(Arm 1D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally；

Intervention Type: DRUG

SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

(Arm 1F) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

Intervention Type: DRUG

SHR-A1811, SHR-1316, and 5-FU

(Arm 1G) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Intervention Type: DRUG

SHR-A1811, SHR-1316, and capecitabine

(Arm 2A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316 administered as an IV infusion; Drug：capecitabine, administered orally；

Intervention Type: DRUG

SHR-1316 and SHR-A1811

(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion

Intervention Type: DRUG

SHR-A1811 and capecitabine

(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally；

Intervention Type: DRUG

SHR-A1811, SHR-1316, and 5-FU

(Arm 2D) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Intervention Type: DRUG

SHR-A1811and 5-FU

(Arm 2E) Drug: SHR-A1811, administered as an IV infusion Drug：5-FU，administered as an IV infusion

Intervention Type: DRUG

SHR-A1811, SHR-1316, capecitabine,and oxaliplatin

(Arm 2F) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1316, administered as an IV infusion Drug：capecitabine, administered orally； Drug：oxaliplatin，administered as an IV infusion

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age from 18 to 75, Male and female participants

2. Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;

3. HER2 expression ;

4. Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;

5. ECOG 0-1;

6. The expected survival ≥3 months;

7. Sufficient bone marrow and organ functions;

Exclusion Criteria

1. There were ascites, pleural effusion and pericardial effusion that needed to be treated;

2. Major surgery was performed within 4 weeks;

3. Have active autoimmune disease or history of autoimmune disease;

4. Patients with interstitial pneumonia;

5. There was severe infection within 4 weeks before starting the study treatment;

6. Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;

7. Serious cardiovascular and cerebrovascular diseases;

8. Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Suzhou Suncadia Biopharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, FuDan University

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

SHR-A1811-Ib/II-205

Identifier Type: -

Identifier Source: org_study_id