Advanced Solid Tumors
Conditions
Brief summary
The study is being conducted to evaluate safety, tolerability and preliminary efficacy of SHR-A1811 for Injection in combination with Fluzoparib Capsule for HER2-expressing advanced solid tumors of patients. To explore the reasonable dosage of dosage regimen of combination therapy for HER2-expressing advanced malignant tumors of patients.
Interventions
DRUGSHR-A1811
SHR-A1811 for Injection: Given IV.
DRUGFluzoparib Capsule
Fluzoparib Capsule: Given PO.
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
SHR-A1811 for Injection in combination with Fluzoparib Capsule.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged ≥18 years at the time of signing the ICF. 2. At least one measurable lesion that meets RECIST 1.1 criteria in case of solid tumors. 3. An Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1. 4. Life expectancy ≥12 weeks. 5. Adequate organ functions as defined. 6. Swallow the drug pills normally.
Exclusion criteria
1. patients with active meningeal metastasis, or brain metastasis without surgical treatment or radiotherapy. 2. Cancerous ascites and pleural effusion with clinical symptoms, which need puncture and drainage. 3. Prior malignancy (other than current malignant tumor) within 5 years before the first dose of study treatment. 4. History of autoimmune diseases. 5. Not well controllable and serve cardiovascular disease. 6. Prior lung disease with clinical significance. 7. Occurrence of ≥ grade 2 of bleeding event within 4 weeks before the first dose, or currently receiving the anticoagulation. 8. Active Hepatitis B and Hepatitis C; or serve infection with medication control. 9. The grade of toxicity from the prior anti-cancer therapy not decrease to ≤ 1. 10. Occurrence of intestinal obstruction and gastrointestinal perforation within 3 months before the first dose.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose Limited Toxicity | first dose of study medication up to 21 days | Dose Limited Toxicity of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period |
| Recommended phase II dose | first dose of study medication up to 21 days | The Recommended phase II dose of SHR-A1811 for Injection in combination with Fluzoparib Capsule in Dose Exploration Period |
| ORR | from the date of the first dose to the date of disease progression evaluated based on RECIST v1.1 criteria, or initiation of other anti-tumor treatment, whichever occurs first, up to 6 months | Objective Response Rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients in indication expansion period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months | Progression-free survival, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients |
| OS | from the date of the first dose to the date of death for any reason, up to 100 months | Overall survival, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients |
| 12 months' survival rate | from the date of the first dose up to 12 months | Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients |
| Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) | from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months | Incidence and severity of adverse events (AEs)/serious adverse events (SAEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| The occurrence rate of dose titration due to AE related with study medication | from signature completion of ICF to 30 days after the last dose or to the beginning of the new anti-cancer therapy, up to 6 months | The occurrence rate of dose interruption, dose decrease and dose termination because of study drug related toxicity during the study |
| DoR | from the date of the firstly documented tumor response (evaluated based on RECIST v1.1 criteria) to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months | Duration of response, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients |
| C3h | 3 hour after first dose of Fluzoparib Capsule in C2D1 | PK concentration of Fluzoparib Capsule |
| AUC0-t | the date of first dose to 30 days after last dose | PK parameters of SHR-A1811 for Injection |
| Cmax | the date of first dose to 30 days after last dose | PK parameters of SHR-A1811 for Injection |
| ADA | the date of first dose up to 90 days after last dose | Anti-drug antibody, Immunogenicity of SHR-A1811 for Injection |
| NAb | the date of first dose up to 90 days after last dose | Neutralizing Antibody, Immunogenicity of SHR-A1811 for Injection |
| Cmin | 10 min before first dose of Fluzoparib Capsule in C1D8 to 10 min before first dose of Fluzoparib Capsule in C8D1 | PK concentration of Fluzoparib Capsule |
| DCR | from the date of the first dose to the date of the firstly documented disease progression (evaluated based on RECIST v1.1 criteria) or the date of death for any reason, up to 6 months | Disease control rate, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients |
| TTR | from the date of the first dose to the date of treatment termination, up to 6 months | Time to Recovery, Efficacy endpoints of SHR-A1811 for Injection in combination with Fluzoparib Capsule in HER2-Expressing Advanced Solid Tumors of Patients |
Countries
China
Outcome results
None listed