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The goal of this clinical trial is to learn if the study drug can work in advanced cancer patients. The main questions it aims to answer are:
Participants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.
Target population are patients with FGFR2-expressing solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM 2020 | Experimental | HDM2020 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM2020 | Drug | FGFR2b-ADC |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal tolerance dose (MTD) of HDM2020 | Maximum-tolerated dose (MTD) was defined as the dose level at which the estimated toxicity probability is closest to the target toxicity probability during the dose-escalation phase, within the DLT observation period (21 days) following the first administration of the IMP. | DLT will be evaluated on 21 days of observation period |
| Incidence of Treatment-Emergent Adverse Events | Incidence rates of adverse events (AE), serious adverse events (SAE) | Estimated 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak (Tmax) | Tmax of HDM2020, total antibody, and exatecan will be measured | Estimated 1 year |
| Half-life time (t1/2) | t1/2 of HDM2020, total antibody, and exatecan will be measured |
| Measure | Description | Time Frame |
|---|---|---|
| Target expression levels | Target expression levels and their correlation with antitumor activity. | Estimated 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ruihua Xu | Contact | 86-020-87343468 | rhuaxu@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
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| Estimated 1 year |
| Peak Plasma Concentration (Cmax) | Cmax of HDM2020, total antibody, and exatecan will be measured | Estimated 1 year |
| Area under the plasma concentration versus time curve (AUC) | AUC of HDM2020, total antibody, and exatecan will be measured | Estimated 1 year |
| Objective response rate (ORR) | Objective response rate (ORR) assessed based on RECIST v1.1 criterion | Estimated 1 year |
| Duration of response (DoR) | Duration of response (DoR) assessed based on RECIST v1.1 criterion | Estimated 1 year |
| Disease control rate (DCR) | Disease control rate (DCR) assessed based on RECIST v1.1 criterion | Estimated 1 year |
| Progression-free survival (PFS) | Progression-free survival (PFS) assessed based on RECIST v1.1 criterion | Estimated 1 year |
| Overall survival (OS) | Overall survival (OS) of 6-months and 12-months | Estimated 1 year |