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This trial is an open, dose escalation phase I clinical study. Subjects can only enter this study after they meet the inclusion and exclusion criteria.Into subjects will accept HLX60 intravenous infusion, every 3 weeks, treatment until lose clinical benefit, toxicity, death, revocation of informed consent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX60 Group | Experimental | The initial dose of HLX60 is 0.5mg/kg, and 5 dose levels are designed: 2mg/kg, 5mg/kg, 15mg/kg and 25mg/kg (Q3W). Patients will receive the treatment until without any clinical benefit, death, intolerable toxicity, or withdraw the informed consent (whichever occurs first) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX60 | Drug | HLX60(anti-GARP Monoclonal Antibody)have 5 dose cohorts: 0.5, 2, 5, 15, 25mg/kg, intravenous infusion, every 3 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | The Dose-Limiting Toxicity (DLT) of HLX60 within 3 weeks after the first Administration in patients with Advanced/Metastatic Solid Tumors or Lymphomas | from day1 to day 21 |
| MTD | The Maximum Tolerated Dose (MTD) of HLX60 within 3 weeks after the first Administration in patients with Advanced/Metastatic Solid Tumors or Lymphomas | from day1 to day 21 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, College of medicine, Zhejiang University | Hangzhou | 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 |