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Monoclonal Antibodies

SHR-A1811 for Solid Tumors

Phase 1
Waitlist Available
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
No Placebo-Only Group

Summary

This trial is testing a new drug called SHR-A1811 to see if it is safe and effective for patients with advanced cancers that have the HER2 gene. The drug works by targeting and attacking these specific cancer cells.

Who is the study for?
This trial is for adults with advanced solid tumors that show HER2 expression or mutation, who have tried standard treatments without success or can't tolerate them. Participants must be in good physical condition (ECOG 0-1), have a heart's pumping ability of at least 50%, and proper kidney and liver function. Women must not be pregnant or breastfeeding.
What is being tested?
The study tests SHR-A1811, focusing on its safety, how the body processes it, if it causes any immune reactions, and whether it can shrink tumors. It's an early-phase trial where all participants receive SHR-A1811 to see how well it works against different types of solid tumors.
What are the potential side effects?
Potential side effects are not explicitly listed but may include typical reactions to cancer therapies such as fatigue, nausea, allergic responses, organ inflammation based on similar drugs targeting HER2 proteins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence and severity of adverse events (AEs)
Secondary study objectives
Immunogenicity of SHR-A1811
PK parameter: AUC0-t of SHR-A1811
PK parameter: Cmax of SHR-A1811
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part 3 Indication expansionExperimental Treatment1 Intervention
Group II: Part 2 PK expansionExperimental Treatment1 Intervention
Group III: Part 1 Dose escalationExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Jiangsu HengRui Medicine Co., Ltd.Lead Sponsor
651 Previous Clinical Trials
99,883 Total Patients Enrolled
Atridia Pty Ltd.Industry Sponsor
28 Previous Clinical Trials
805 Total Patients Enrolled

Media Library

SHR-A1811 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04446260 — Phase 1
Solid Tumors Research Study Groups: Part 2 PK expansion, Part 3 Indication expansion, Part 1 Dose escalation
Solid Tumors Clinical Trial 2023: SHR-A1811 Highlights & Side Effects. Trial Name: NCT04446260 — Phase 1
SHR-A1811 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04446260 — Phase 1
~82 spots leftby Dec 2025
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