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Nimotuzumab is an IgG1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (EGFR), inhibiting tyrosine kinase activation. It has been approved to treat squamous cell carcinoma of head and neck (SCCHN), glioma and nasopharyngeal carcinoma in different countries. Currently, the registered clinical trials of Nimotuzumab combined with chemotherapy in advanced non-small cell lung cancer, colorectal cancer, esophageal cancer and glioma have been approved and are ongoing all over the investigators' country. The main purpose of this study is to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
This is a single-centered, non-randomized and open-labeled Clinical Pharmacokinetics Study of Nimotuzumab in patients with solid tumors. The test includes 3 dose groups, namely Single dose group, Multiple single-week dose group and Multiple bi week dose group, to evaluate the pharmacokinetic characteristics of Nimotuzumab combined with Irinotecan in patients with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-dose PK | Experimental | single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation. 1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle. |
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| Weekly fixed dose | Experimental | Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks. |
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| Bioweekly fixed dose PK | Experimental | Nimotuzumab 600mg, administered once every 2 weeks for 8 weeks. Dosing regimens can be adjusted according to the results of preliminary experiments. Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation;Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks;600mg, administered once every 2 weeks for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of Nimotuzumab after administration of escalating single dosing and weekly fixed dosing in patients with solid tumors: Single dose:Tmax,Cmax, AUC,Vc,t1/2α,t1/2β,CL. Multiple dose:Tmax,Css-min,Css-max,Css-a,t1/2β,CL,AUCss,DF. | The measure is a composite.The measure of single dose:Tmax,Cmax, AUC,Vc,t1/2α,t1/2β,CL. The measure of multiple dose:Tmax,Css-min,Css-max,Css-a,t1/2β,CL,AUCss,DF. | up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety - AE measured by NCI CTCAE v 3.0 | Safety evaluations included adverse events and changes in laboratory data.Adverse events were descriptive statistics, lists the event occurred, the duration, severity, and drug relationship, as well as its outcome. | Any adverse medical events occur from the beginning of receiving study drug to the end of treatment after 30 days |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinwan Wang, PhD,MD | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute & Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100000 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 21, 2023 | |
| Reset | Mar 1, 2024 | |
| Release | Mar 5, 2024 | |
| Reset | Aug 9, 2024 | |
| Release | Feb 5, 2025 | |
| Reset | Feb 25, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 21, 2023 | Mar 1, 2024 | |||
| Mar 5, 2024 |
| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D000077146 | Irinotecan |
| ID | Term |
|---|---|
| D002166 | Camptothecin |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| irinotecan | Drug | Single-dose PK:1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle. Bioweekly fixed dose PK:Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h |
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| ORR(Objective Response Rate) | Efficacy as measured by RECIST v1.1 | The third weekend and Ninth weekend |
| DCR(Disease Control Rate) | Efficacy as measured by RECIST v1.1 | The third weekend and Ninth weekend |
| PFS(Progression Free Survival) | Efficacy as measured by RECIST v1.1 | The third weekend and Ninth weekend |
| Aug 9, 2024 |
| Feb 5, 2025 | Feb 25, 2025 |