Advanced Solid Tumors
Conditions
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.
Interventions
DRUGSHR-A1811
be administered via intravenous (IV) infusion
Sponsors
Atridia Pty Ltd.
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and severity of adverse events (AEs) | From Day1 to 90 days after last dose | Frequency and seriousness of treatment emergent adverse events (TEAEs) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response using RECIST 1.1 | 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 |
| PK parameter: Tmax of SHR-A1811 | Through study completion, an average of 1 year | Time to maximal concentration (Tmax) of SHR-A1811 |
| PK parameter: Cmax of SHR-A1811 | Through study completion, an average of 1 year | Maximal concentration (Cmax) of SHR-A1811 |
| PK parameter: AUC0-t of SHR-A1811 | 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 |
| Immunogenicity of SHR-A1811 | Through study completion, an average of 1 year | Including anti-drug antibody and/or neutralizing antibody |
Countries
Australia, China, South Korea, Taiwan, United States
Outcome results
None listed