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The goal of this clinical trial is to learn if the study drug can treat in advanced squamous non-small cell lung cancer(NSCLC) patients. The main questions it aims to answer are:
Is the drug safe and tolerable? Does the drug show antitumor activity? Participants will receive the study drug once(D1) or twice(D1.D8) every three weeks, and undergo imaging-based efficacy assessments every six weeks.
Target population are patients with FGFR2-expressing late line squamous non-small cell lung cancer(NSCLC) tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HDM 2020 | Experimental | HDM2020 Intravenous administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM2020 (FGFR2b-ADC) | Drug | This Phase I study only focuses on squamous non-small cell lung cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | Incidence rates of adverse events (AE), serious adverse events (SAE) | Up to 2 years |
| Objective response rate (ORR) | Objective response rate (ORR) assessed based on RECIST v1.1 criterion | Up to 2 years |
| Disease control rate (DCR) | Disease control rate (DCR) assessed based on RECIST v1.1 criterion | Up to 2 years |
| Duration of response (DoR) | Duration of response (DoR) assessed based on RECIST v1.1 criterion | Up to 2 years |
| Progression-free survival (PFS) | Progression-free survival (PFS) assessed based on RECIST v1.1 criterion | Up to 2 years |
| Overall survival (OS) | Overall survival (OS) of 6-months and 12-months | Up to 2 years |
| Recommended Phase 2 Dose (RP2D) | Recommended Phase 2 Dose | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak (Tmax) | Tmax of HDM2020, total antibody, and exatecan will be measured | Up to 2 years |
| 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. | Up to 2 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Binchao Wang | Contact | 86-020-81884713 -80521 | 13059161908 | wangbinchao@gdph.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| Up to 2 years |
| Peak Plasma Concentration (Cmax) | Cmax of HDM2020, total antibody, and exatecan will be measured | Up to 2 years |
| Area under the plasma concentration versus time curve (AUC) | AUC of HDM2020, total antibody, and exatecan will be measured | Up to 2 years |