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

Suzhou Suncadia Biopharmaceuticals

Status and phase: Active, not recruiting; Phase 2

Conditions: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma

Treatments: Drug: SHR-A1811, SHR-1316, capecitabine,and oxaliplatin; Drug: SHR-A1811, SHR-1316, and capecitabine; Drug: SHR-A1811and 5-FU; Drug: SHR-A1811 and capecitabine; Drug: SHR-A181, SHR-1701, and capecitabine; Drug: SHR-A1811, SHR-1316, and 5-FU; Drug: SHR-A1811 and SHR-1701; Drug: SHR-1316 and SHR-A1811

Study type: Interventional

Funder types: Industry

Identifiers

NCT05671822

SHR-A1811-Ib/II-205

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 12 patient groups

Arm 1A: SHR-A1811 and SHR-1701

Experimental group

Treatment:

Drug: SHR-A1811 and SHR-1701

Arm 1B: SHR-A1811 and capecitabine

Experimental group

Treatment:

Drug: SHR-A1811 and capecitabine

Drug: SHR-A1811 and capecitabine

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

Experimental group

Treatment:

Drug: SHR-A181, SHR-1701, and capecitabine

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

Experimental group

Treatment:

Drug: SHR-A1811, SHR-1316, and capecitabine

Drug: SHR-A1811, SHR-1316, and capecitabine

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

Experimental group

Treatment:

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

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

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

Experimental group

Treatment:

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

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

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

Experimental group

Treatment:

Drug: SHR-A1811, SHR-1316, and capecitabine

Drug: SHR-A1811, SHR-1316, and capecitabine

Arm 2B: SHR-1316 and SHR-A181

Experimental group

Treatment:

Drug: SHR-1316 and SHR-A1811

Arm 2C: SHR-A1811 and capecitabine

Experimental group

Treatment:

Drug: SHR-A1811 and capecitabine

Drug: SHR-A1811 and capecitabine

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

Experimental group

Treatment:

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

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

Arm 2E: SHR-A1811and 5-FU

Experimental group

Treatment:

Drug: SHR-A1811and 5-FU

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

Experimental group

Treatment:

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

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