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History of Changes for Study: NCT04446260
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Latest version (submitted December 22, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 June 22, 2020 None (earliest Version on record)
2 October 16, 2020 Recruitment Status, Study Status and Contacts/Locations
3 November 10, 2020 Contacts/Locations, Oversight and Study Status
4 November 9, 2021 Contacts/Locations and Study Status
5 December 22, 2021 Study Status and Contacts/Locations
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Study NCT04446260
Submitted Date:  June 22, 2020 (v1)

Open or close this module Study Identification
Unique Protocol ID: SHR-A1811-I-101
Brief Title: A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Official Title: A Phase 1 Multi-Country, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SHR-A1811 in HER2 Expressing or Mutated Advanced Malignant Solid Tumor Subjects
Secondary IDs:
Open or close this module Study Status
Record Verification: June 2020
Overall Status: Not yet recruiting
Study Start: July 2020
Primary Completion: December 2023 [Anticipated]
Study Completion: December 2023 [Anticipated]
First Submitted: June 18, 2020
First Submitted that
Met QC Criteria:
June 22, 2020
First Posted: June 24, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:
June 22, 2020
Last Update Posted: June 24, 2020 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Responsible Party: Sponsor
Collaborators: Atridia Pty Ltd.
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module Study Description
Brief Summary: This is an open-label, two-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-A1811 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Detailed Description:
Open or close this module Conditions
Conditions: Advanced Solid Tumors
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 226 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Part 1 Dose escalation Drug: SHR-A1811
be administered via intravenous (IV) infusion
Experimental: Part 2 Indication expansion Drug: SHR-A1811
be administered via intravenous (IV) infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence and severity of adverse events (AEs)
[ Time Frame: From Day1 to 90 days after last dose ]

Frequency and seriousness of treatment emergent adverse events (TEAEs)
Secondary Outcome Measures:
1. PK parameter: Tmax of SHR-A1811
[ Time Frame: Through study completion, an average of 1 year ]

Time to maximal concentration (Tmax) of SHR-A1811
2. PK parameter: Cmax of SHR-A1811
[ Time Frame: Through study completion, an average of 1 year ]

Maximal concentration (Cmax) of SHR-A1811
3. PK parameter: AUC0-t of SHR-A1811
[ Time Frame: Through study completion, an average of 1 year ]

AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
4. Immunogenicity of SHR-A1811
[ Time Frame: Through study completion, an average of 1 year ]

Including anti-drug antibody and/or neutralizing antibody
5. Tumor response using RECIST 1.1
[ Time Frame: From first dose to disease progression or death, whichever comes first, up to 30 months ]

RECIST=Response Evaluation Criteria in Solid Tumors Assessment of tumor response until disease progression or death to evaluate the efficacy of SHR-A1811 up to 30 months
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Advanced/unresectable or metastatic solid tumor with HER2 expression or mutation that is refractory to or intolerable with standard treatment, or for which no standard treatment is available
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • LVEF ≥ 50% by either ECHO or MUGA
  • Has adequate renal and hepatic function
  • Female subjects agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment

Exclusion Criteria:

  • History of clinically significant lung diseases (e.g., interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or suspected to have these diseases by imaging at screening period
  • Known hereditary or acquired bleeding and thrombotic tendency
Open or close this module Contacts/Locations
Central Contact Person: Sherry Zhu, MD, PhD
Telephone: +86 021-61053363
Email: zhuxiaoyu@hrglobe.cn
Central Contact Backup: Catherine Rong
Telephone: +86 021-61053363
Email: rongshangyi@hrglobe.cn
Locations:
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services