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Trial Title:
Ph1b/2 Study of the Safety and Efficacy of SHR-A1811 Combinations in Advanced HER2+ Gastric Cancer
NCT ID:
NCT05671822
Condition:
HER2+ Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Stomach Neoplasms
Esophageal Neoplasms
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR-A1811；SHR-1701；capecitabine；oxaliplatin
Description:
(Arm 1A) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701, administered as
an IV infusion; (Arm 1B) Drug: SHR-A1811,administered as an IV infusion
Drug：capecitabine, administered orally； (Arm 1C) Drug: SHR-A1811,administered as an IV
infusion Drug: SHR-1701, administered as an IV infusion Drug：capecitabine, administered
orally； (Arm 1D) Drug: SHR-A1811,administered as an IV infusion Drug：capecitabine,
administered orally； Drug：oxaliplatin，administered as an IV infusion
Arm group label:
Arm 1A: SHR-A1811 and SHR-1701
Arm group label:
Arm 1B: SHR-A1811 and capecitabine
Arm group label:
Arm 1C: SHR-A181,SHR-1701,and capecitabine
Arm group label:
Arm 1D: SHR-A1811,capecitabine,and oxaliplatin
Intervention type:
Drug
Intervention name:
SHR-A1811；SHR-1701；capecitabine；oxaliplatin
Description:
(Arm 2A) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701, administered as
an IV infusion; (Arm 2B) Drug: SHR-A1811,administered as an IV infusion Drug: SHR-1701,
administered as an IV infusion Drug：capecitabine, administered orally； (Arm 2C) Drug:
SHR-A1811,administered as an IV infusion Drug：capecitabine, administered orally；
Drug：oxaliplatin，administered as an IV infusion
Arm group label:
Arm 2A: SHR-A1811 and SHR-1701
Arm group label:
Arm 2B: SHR-A181,SHR-1701,and capecitabine
Arm group label:
Arm 2C: SHR-A1811,capecitabine,and oxaliplatin
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-positive 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-positive
gastric/gastroesophageal conjunctional adenocarcinoma patients.
Criteria for 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 positive;
4. Phase Ib: progression at least one prior Regimen or could not tolerate the standard
treatment，pevious anti-HER2 therapy was included 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;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Zhongshan Hospital, FuDan University
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Investigator:
Last name:
Tianshu Liu
Email:
Principal Investigator
Start date:
March 14, 2023
Completion date:
July 30, 2026
Lead sponsor:
Agency:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Agency class:
Industry
Source:
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05671822
