Status:
ACTIVE_NOT_RECRUITING
A Phase 1 Study of SHR-A1811 in Patients With Selected HER2 Expressing Tumors
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Gastric Cancer
Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single arm, open-label, dose escalation, PK expansion and efficacy expansion study of phase I. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogen...
Eligibility Criteria
Inclusion
- Has a pathologically or cytologically documented advanced/unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma and colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
- At least one evaluable or measurable lesion should be present and identified according to Response Evaluation Criteria in Solid Tumors(RECIST) version 1.1.
- Has an ECOG PS 0-1.
- Has a life expectancy of ≥ 3 months.
- Has adequate organ function
Exclusion
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1.
- Has received HER2 antibody drug conjugates,.
- Central nervous system metastasis or meningeal metastasis with clinical symptoms
- Has active infection requiring systemic treatment.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2024
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04513223
Start Date
March 30 2021
End Date
December 1 2024
Last Update
March 20 2024
Active Locations (1)
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1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, Shanghai