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.
Brief Title
A Study of SHR-A1811 in Subjects With Advanced Malignant Solid Tumors
Completion Date
Completion Date Type
Actual
Conditions
Advanced Solid Tumors
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04446260
Org Class
Industry
Org Full Name
Jiangsu HengRui Medicine Co., Ltd.
Org Study Id
SHR-A1811-I-101
Overall Status
Completed
Phases
Phase 1
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Frequency and seriousness of treatment emergent adverse events (TEAEs)
Outcome Measure
Incidence and severity of adverse events (AEs)
Outcome Time Frame
From Day1 to 90 days after last dose
Secondary Outcomes
Outcome Description
Time to maximal concentration (Tmax) of SHR-A1811
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
PK parameter: Tmax of SHR-A1811
Outcome Description
Maximal concentration (Cmax) of SHR-A1811
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
PK parameter: Cmax of SHR-A1811
Outcome Description
AUC computed from time zero to the time of the last quantifiable concentration (AUC0-t) of SHR-A1811
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
PK parameter: AUC0-t of SHR-A1811
Outcome Description
Including anti-drug antibody and/or neutralizing antibody
Outcome Time Frame
Through study completion, an average of 1 year
Outcome Measure
Immunogenicity of SHR-A1811
Outcome Description
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
Outcome Time Frame
From first dose to disease progression or death, whichever comes first, up to 30 months
Outcome Measure
Tumor response using RECIST 1.1
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Andreas Kaubisch
Investigator Email
akaubisc@montefiore.org
Investigator Phone
718-920-7100