Advanced Solid Tumor
Conditions
Brief summary
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects.
Interventions
DRUGSHR-4602 for injection
be administered via intravenous (IV) infusion
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is an open-label, three-part study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of SHR-4602 and preliminary anti-tumor efficacy in HER2 expressing or mutated advanced malignant solid tumor subjects. Include three stages: dose escalation, PK expansion, and efficacy expansion.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. 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; 2. At least one measurable lesion based on RECIST v1.1 criteria; 3. ECOG PS score: 0-1 points; 4. Expected survival period ≥ 3 months; 5. Adequate organ function; 6. Must take one medically approved contraceptive measure; 7. Patients voluntarily joined the study and signed informed consent.
Exclusion criteria
1. Patients with known CNS metastasis or hepatic encephalopathy; 2. Suffering from peripheral neuropathy; 3. 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; 4. Patients with any active, known or suspected autoimmune disorder; 5. With known severe allergic reactions to any other monoclonal antibodies; 6. Patients with symptomatic ascites or pleural effusion requiring paracentesis and drainage, or patients who have undergone ascites or pleural effusion drainage within 2 weeks before the first dose; 7. Patients with other malignancies currently or within the past 5 years; 8. Uncontrolled cardiac diseases or symptoms; 9. With known hereditary or acquired bleeding (e.g., coagulopathy) or a tendency to clot (e.g., hemophiliacs); 10. Patients with other potential factors that may affect the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs) | From Day 1 to 90 days after last dose |
| Maximum tolerated dose (MTD) | From Day 1 to 21 days after first dose |
| Dose Limiting Toxicities (DLT) | From Day 1 to 21 days after first dose |
| Recommended Phase 2 dose (RP2D) | From Day 1 to 90 days after last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ADA | the date of first dose up to 90 days after last dose | Anti-drug antibody, Immunogenicity of SHR-4602 for Injection |
| ORR | the date of first dose up to 90 days after last dose | Objective Response Rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1 |
| PK parameters of SHR-4602 for Injection: Cmax | the date of first dose to 30 days after last dose | — |
| DOR | the date of first dose up to 90 days after last dose | Duration of response, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1 |
| PFS | the date of first dose up to 90 days after last dose | Progression Free Survival, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1 |
| DCR | the date of first dose up to 90 days after last dose | Disease control rate, Efficacy endpoints of SHR-4602 for Injection，As assessed by RECIST v1.1 |
| PK parameters of SHR-4602 for Injection: AUC0-t | the date of first dose to 30 days after last dose | — |
| PK parameters of SHR-4602 for Injection: Tmax | the date of first dose to 30 days after last dose | — |
| PK parameters of SHR-4602 for Injection: T1/2 | the date of first dose to 30 days after last dose | — |
Countries
China
Contacts
Primary ContactXin Shi
Backup ContactWenjie Xin
Outcome results
None listed