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This study is a non-randomized, open-label, phase I dose-finding and dose-expansion study to evaluate the safety, tolerability, antitumor efficacy, PK and immunogen of F527 in patients with relapsed or refractory lymphoma sexual characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug:F527 | Experimental | F527 is dose-escalated sequentially by accelerated titration and i3+3 design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| F527 | Drug | 0.001、0.01、0.1、0.3、1、3 and10 mg/kg QW |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLTs | Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period | Up to 21 days |
| Maximum Tolerated Dose (MTD) | Maximum Tolerated Dose | Up to 21 days |
| RP2D | PR2D will be determined by the sponsor and investigator based on the comprehensive data obtained on drug safety and tolerability, PK, preliminary anti-tumor efficacy, etc. | Up to 21 days |
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Inclusion Criteria:
Male or female aged ≥18 and ≤80 years old;
Patients with histopathologically confirmed relapsed/refractory lymphoma; relapsed/refractory was defined as a patient who did not achieve a response (including complete or partial response) after the last systemic therapy regimen, or had disease progression after achieving a response or relapse;
Subjects must have at least one measurable lesion assessed by the investigator (long diameter of lymph node>15mm, long diameter of extranodal lesion>10mm);
Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2;
Expected survival period ≥ 3 months;
The function of vital organs meets the following requirements (do not use any blood components and cytokines within 7 days before the first dose):
Blood routine: neutrophil count ≥1.5×109/L; platelet count ≥75×109/L; hemoglobin ≥95g/L; Liver function: TBIL≤1.5×ULN, ALT and AST≤2.5×ULN; if there is liver metastasis, ALT and AST≤5×ULN; Renal function: creatinine≤1.5×ULN; Coagulation function: International Normalized Ratio (INR)≤1.5×ULN and Activated Partial Thromboplastin Time (APTT)≤1.5×ULN;
Understand the test procedures and content, and sign the informed consent voluntarily.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaohong Yin | Contact | 86-15265901803 | yinshaohong@lunan.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |