Combining SHR-A1811 with chemo and immunotherapy for advanced HER2-expressing stomach and gastroesophageal junction cancer

A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma

This trial will test whether combining SHR-A1811 with chemotherapy and/or immunotherapy helps adults with advanced or metastatic HER2-expressing stomach or gastroesophageal junction cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Suzhou Suncadia Biopharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT05671822 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase Ib/II trial will explore safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of SHR-A1811 in combination with various chemotherapy and immunotherapy agents in patients with advanced or metastatic HER2-expressing gastric or gastroesophageal junction adenocarcinoma. Phase Ib enrolls patients who are either treatment-naïve or have failed or are intolerant to prior standard therapy to establish safe combination regimens. Phase II expands selected combinations to previously untreated patients to measure efficacy and continued safety. Combination partners include agents such as SHR-1701, SHR-1316, capecitabine, and oxaliplatin across multiple cohorts.

Who should consider this trial

Good fit: Adults aged 18–75 with pathologically confirmed advanced or metastatic HER2-expressing gastric or gastroesophageal junction adenocarcinoma, ECOG 0–1, adequate organ and marrow function, and either previously untreated (Phase II) or treatment-naïve/failed or intolerant to prior standard therapy (Phase Ib) are the intended participants.

Not a fit: Patients with active autoimmune disease, interstitial pneumonia, symptomatic effusions requiring treatment, recent major surgery, uncontrolled or recent severe infection, active tuberculosis within one year, or serious cardiovascular/cerebrovascular disease are excluded and are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, these combinations could provide a more effective treatment option that better controls tumor growth and potentially extends survival for people with advanced HER2-expressing gastric or gastroesophageal junction cancer.

How similar studies have performed: Combining HER2-targeted approaches with chemotherapy or immunotherapy has shown benefit in some HER2-positive gastric cancer settings, but SHR-A1811-containing regimens are novel and require clinical testing to confirm benefit.

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;

Where this trial is running

Shanghai, Shanghai Municipality

• Zhongshan Hospital, FuDan University — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Shiwei Sun

Conditions HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma