A Phase 1 interventional study of HDM2020 in Solid Tumor, sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-08-01.
Sponsored by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment
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.
Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. is the lead sponsor of 49 studies on the registry; 38 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
HDM2020
Drug: HDM2020
FGFR2b-ADC
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.
Time frame: 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)
Time frame: Estimated 1 year
Time to peak (Tmax)
Tmax of HDM2020, total antibody, and exatecan will be measured
Time frame: Estimated 1 year
Half-life time (t1/2)
t1/2 of HDM2020, total antibody, and exatecan will be measured
Time frame: Estimated 1 year
Peak Plasma Concentration (Cmax)
Cmax of HDM2020, total antibody, and exatecan will be measured
Time frame: Estimated 1 year
Area under the plasma concentration versus time curve (AUC)
AUC of HDM2020, total antibody, and exatecan will be measured
Time frame: Estimated 1 year
Objective response rate (ORR)
Objective response rate (ORR) assessed based on RECIST v1.1 criterion
Time frame: Estimated 1 year
Duration of response (DoR)
Duration of response (DoR) assessed based on RECIST v1.1 criterion
Time frame: Estimated 1 year
Disease control rate (DCR)
Disease control rate (DCR) assessed based on RECIST v1.1 criterion
Time frame: Estimated 1 year
Progression-free survival (PFS)
Progression-free survival (PFS) assessed based on RECIST v1.1 criterion
Time frame: Estimated 1 year
Overall survival (OS)
Overall survival (OS) of 6-months and 12-months
Time frame: Estimated 1 year
Target expression levels
Target expression levels and their correlation with antitumor activity.
Time frame: Estimated 1 year
Plan to share: No
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Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.