Clinical trial · Interventional
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR-1316 and SHR-A1811 | Drug | — | UNRESOLVED |
| SHR-A1811and 5-FU | Drug | — | UNRESOLVED |
| SHR-A1811 and capecitabine | Drug | — | UNRESOLVED |
| SHR-A1811 and SHR-1701 | Drug | — | UNRESOLVED |
| SHR-A1811, SHR-1316, and 5-FU | Drug | — | UNRESOLVED |
| SHR-A1811, SHR-1316, and capecitabine | Drug | — | UNRESOLVED |
| SHR-A1811, SHR-1316, capecitabine,and oxaliplatin | Drug | — | UNRESOLVED |
| SHR-A181, SHR-1701, and capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- Arm 1A: SHR-A1811 and SHR-1701
- interventionNames
- Drug: SHR-A1811 and SHR-1701
- type
- EXPERIMENTAL
- label
- Arm 1B: SHR-A1811 and capecitabine
- interventionNames
- Drug: SHR-A1811 and capecitabine
- type
- EXPERIMENTAL
- label
- Arm 1C: SHR-A181, SHR-1701, and capecitabine
- interventionNames
- Drug: SHR-A181, SHR-1701, and capecitabine
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
Data not yet available