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

Recruiting Phase 2 Interventional Study
HER2 Expression Gastric Cancer/Gastroesophageal Junction Adenocarcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
258 (estimated)
Sponsor
Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Industry
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About This Trial
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 effi…
Trial Locations
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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 no…
Contacts

Shiwei Sun

+86 18036618554

Shiwei.sun@hengrui.com

CONTACT