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Due to changes in the sponsor's research strategy
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The purpose of this study is to assess the safety and tolerability of gentulizumab, an anti-CD47 Monoclonal Antibody, in participants with solid tumors and non-Hodgkin lymphoma.
This is a first-in-human, escalating dose trial of an antibody that inhibits an anti-apoptotic signal in human macrophages. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental cohort | Experimental | Gentulizumab monotherapy 0.1, 0.3, 1, 3, 10, 30, 45 mg/kg administered intravenously once every week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gentulizumab | Drug | Gentulizumab is administered IV once a week, with every 4 weeks as an administration cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of Gentulizumab as Measured by the Number of Participants Experiencing Dose-limiting Toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs). | The CTCAE criteria will be used to assess adverse events on this trial. | 28 days |
| Pharmacokinetic (PK) Parameter: Area under the plasma concentration versus time curve (AUC). | From the first dosing to 90 days after the last dosing | |
| Pharmacokinetic (PK) Parameter: Peak plasma concentration (Cmax). | From the first dosing to 90 days after the last dosing | |
| Pharmacokinetic (PK) Parameter: Terminal phase half-life (t1/2). | From the first dosing to 90 days after the last dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamic (PD) Characteristics of Gentulizumab. | PD parameters include: receptor occupancy (RO) of gentulizumab of red blood cells, and white blood cells in peripheral blood. | From the first dosing to 90 days after the last dosing |
| Immunogenicity of Gentulizumab. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) of Gentulizumab as Monotherapy. | ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR) per RECIST v1.1 by investigator determination. | From date of first dosing until the date of disease progression or death due to any cause, whichever came first, assessed up to 12 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Zhang, Doctor | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jian Zhang | Shanghai | Shanghai Municipality | 20032 | China | ||
| Zhejiang Cancer Hospital |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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Numbers of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) positive participants will be used to assess the immunogenicity of gentulizumab. |
| From the first dosing to 28 days after the last dosing |
| Progression-free Survival (PFS) of Gentulizumab as Monotherapy. | PFS was defined as the time ranging from the beginning of enrollment to the tumor progression for the first time or death. | From date of first dosing until the date of disease progression or death due to any cause, whichever came first, assessed up to 12 months. |
| Exploratory indicators related to biomarkers | 12 months |
| Hangzhou |
| Zhejiang |
| 310022 |
| China |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |