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Monoclonal Antibodies
SHR-A1811 for Solid Tumors
Phase 1
Recruiting
Research Sponsored by Jiangsu HengRui Medicine Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and effective against HER2-expressing solid tumors.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and severity of adverse events (AEs)
Secondary outcome measures
Immunogenicity of SHR-A1811
PK parameter: AUC0-t of SHR-A1811
PK parameter: Cmax of SHR-A1811
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Part 2 Indication expansionExperimental Treatment1 Intervention
Group II: Part 1 Dose escalationExperimental Treatment1 Intervention
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Who is running the clinical trial?
Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
633 Previous Clinical Trials
95,863 Total Patients Enrolled
Atridia Pty Ltd.Industry Sponsor
25 Previous Clinical Trials
772 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Part 1 Dose escalation
- Group 2: Part 2 Indication expansion
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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