Recruiting NCT05671822
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2 Expression Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811 and SHR-1701, SHR-A1811 and capecitabine, SHR-A181, SHR-1701, and capecitabine, SHR-A1811, SHR-1316, and capecitabine.
- Who it may be relevant to
- Registry conditions: HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase Ib/II Study of SHR-A1811 Combinations in Patients With Advanced/Metastatic HER2 Expression Gastric /Gastroesophageal Junction Adenocarcinoma
Overview
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.
Interventions
- Drug SHR-A1811 and SHR-1701
(Arm 1A) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1701, administered as an IV infusion; - Drug SHR-A1811 and capecitabine
(Arm 1B) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally； - 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； - 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； - 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 - 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 - 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； - Drug SHR-1316 and SHR-A1811
(Arm 2B) Drug: SHR-A1811, administered as an IV infusion Drug: SHR-1316, administered as an IV infusion - Drug SHR-A1811 and capecitabine
(Arm 2C) Drug: SHR-A1811, administered as an IV infusion Drug：capecitabine, administered orally； - 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
Primary outcome measures
- Phase Ib: Dose limiting toxicity (DLT) rates, Occurrence of adverse events (AEs), and serious adverse events (SAEs) [Time frame: Safety will be assessed for approximately 24 months from informed consent]
- Phase II: Objective Response Rate (ORR)[ [Time frame: An average of approximately 12 months]
Secondary outcome measures (8)
- ORR（Phase Ib） [Time frame: An average of approximately 12 months]
- DoR（Phase Ib） [Time frame: An average of approximately 18 months]
- PFS（Phase Ib） [Time frame: An average of approximately 18 months]
- OS（Phase Ib） [Time frame: An average of approximately 30 months]
- DoR（Phase II） [Time frame: An average of approximately 18 months]
- PFS（Phase II） [Time frame: An average of approximately 18 months]
- OS（Phase II） [Time frame: An average of approximately 30 months]
- Occurrence of adverse events (AEs), and serious adverse events (SAEs) （Phase II） [Time frame: Safety will be assessed for approximately 24 months from informed consent]]
Eligibility criteria
Inclusion criteria
- Age from 18 to 75, Male and female participants
- Local advanced unresectable or metastatic disease Pathologically documented adenocarcinoma of gastric or gastroesophageal junction;
- HER2 expression ;
- Phase Ib: Failed or intolerant to prior standard treatment, or did not receive any systemic anti-tumor therapy; Phase II: previously untreated patients;
- ECOG 0-1;
- The expected survival ≥3 months;
- Sufficient bone marrow and organ functions;
Exclusion criteria
- There were ascites, pleural effusion and pericardial effusion that needed to be treated;
- Major surgery was performed within 4 weeks;
- Have active autoimmune disease or history of autoimmune disease;
- Patients with interstitial pneumonia;
- There was severe infection within 4 weeks before starting the study treatment;
- Patients with active pulmonary tuberculosis infection history within 1 year before enrollment;
- Serious cardiovascular and cerebrovascular diseases;
- Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Zhongshan Hospital, FuDan University — Shanghai
Identifiers
NCT: NCT05671822 · SHR-A1811-Ib/II-205