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

Phase 2

Active, not recruiting

• Conditions: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
• Interventions: Drug: SHR-A1811 and SHR-1701; Drug: SHR-A1811 and capecitabine; Drug: SHR-A181, SHR-1701, and capecitabine; Drug: SHR-A1811and 5-FU; Drug: SHR-A1811, SHR-1316, and capecitabine; Drug: SHR-A1811, SHR-1316, and 5-FU; Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin; Drug: SHR-1316 and SHR-A1811

• Registration Number: NCT05671822
• Lead Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-03
• Study First Posted: 2023-01-05
• Study Start: 2023-03-14
• Status Verified: 2025-04
• Primary Completion: 2025-04-02
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 76

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1A: SHR-A1811 and SHR-1701	SHR-A1811 and SHR-1701	-
Arm 1B: SHR-A1811 and capecitabine	SHR-A1811 and capecitabine	-
Arm 1C: SHR-A181, SHR-1701, and capecitabine	SHR-A181, SHR-1701, and capecitabine	-
Arm 2E: SHR-A1811and 5-FU	SHR-A1811and 5-FU	-
Arm 1D: SHR-A1811, SHR-1316, and capecitabine	SHR-A1811, SHR-1316, and capecitabine	-
Arm 2D: SHR-A1811, SHR-1316, and 5-FU	SHR-A1811, SHR-1316, and 5-FU	-
Arm 1F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin	SHR-A1811, SHR-1316, capecitabine,and oxaliplatin	-
Arm 2A: SHR-A1811, SHR-1316, and capecitabine	SHR-A1811, SHR-1316, and capecitabine	-
Arm 1G: SHR-A1811, SHR-1316, and 5-FU	SHR-A1811, SHR-1316, and 5-FU	-
Arm 2B: SHR-1316 and SHR-A181	SHR-1316 and SHR-A1811	-
Arm 2C: SHR-A1811 and capecitabine	SHR-A1811 and capecitabine	-
Arm 2F: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin	SHR-A1811, SHR-1316, capecitabine,and oxaliplatin	-

Primary Outcome Measures

Name	Time	Method
Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs)	Safety will be assessed for approximately 24 months from informed consent
Phase II: Objective Response Rate (ORR)[	An average of approximately 12 months

Secondary Outcome Measures

Name	Time	Method
DoR（Phase II）	An average of approximately 18 months
ORR（Phase Ib）	An average of approximately 12 months
DoR（Phase Ib）	An average of approximately 18 months
PFS（Phase Ib）	An average of approximately 18 months
OS（Phase Ib）	An average of approximately 30 months
PFS（Phase II）	An average of approximately 18 months
OS（Phase II）	An average of approximately 30 months
Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II）	Safety will be assessed for approximately 24 months from informed consent]

Trial Locations

Locations (1)

Zhongshan Hospital, FuDan University; 🇨🇳 Shanghai, Shanghai, China