HER2 Positive Solid Tumor Clinical Trial
Official title:
A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
| Verified date | April 2024 |
| Source | Peking University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
| Status | Completed |
| Enrollment | 48 |
| Est. completion date | December 1, 2023 |
| Est. primary completion date | September 22, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | Inclusion Criteria: - Signed inform consent form (ICF) - Age = 18 years and = 75 years, male or female - Histologically or cytologically documented advanced HER2 positive solid tumor - Received at least one prior standard therapy - At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors(RECISIT) v 1.1 - Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 - Adequate organ function - LVEF= 50% (ECHO) - Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed. - Ability to comply with treatment, procedures and pharmacokinetics (PK) sample collection and the required study follow-up procedures Exclusion Criteria: - Accepted any other anti-tumor drug therapies within 4 weeks before fist dose - Accepted radiotherapy within 4 weeks before enrollment - An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines - Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible - Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids) - Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines) - Pregnant or nursing females;or intend pregnancy within this study period or within 6 monthes after the end of this study - Severe chronic and active infection, need to system antibiosis/antiviral treatment - Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management - Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage |
| Country | Name | City | State |
|---|---|---|---|
| China | Beijing Cancer Hospital | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Peking University | Jiangsu Alphamab Biopharmaceuticals Co., Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Dose-limiting toxicity(DLT) | Dose-limiting toxicity | 28 days | |
| Primary | Objective response rate (ORR) | Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment | up to 2 years | |
| Primary | Duration of response (DOR) | Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment | up to 2 years | |
| Secondary | Clinical benefit rate | Clinical benefit rate | up to 2 years | |
| Secondary | Progression free survival (PFS) rates | Progression free survival (PFS) rates | 6 months and 12 months | |
| Secondary | Overall survival (OS) rates | Overall survival (OS) rates | 6 months and 12 months |