A Study of HDM2020 in Patients With Advanced Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
About this trial
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:
* Is the drug safe and tolerable ? * Does the drug exhibit antitumor activity ?
Participants will receive the study drug once every three weeks, and imaging-based efficacy assessments will be performed every six weeks.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants who understand and voluntarily (or legal guardian) sign a written ICF approved by the Institutional Review Board or Independent Ethics Committee.
Male or female participants aged ≥18 years.
Participants must be patients with advanced or metastatic malignant solid tumors confirmed by histology or cytology, and have experienced sufficient standard treatment failure, or are intolerant to standard treatment, or have no effective standard treatment.
Tumor tissue samples are required to be sent to the central laboratory for IHC testing.
Disqualifiers
Participants with prior treatment with an ADC containing a topoisomerase I (Top I) inhibitor.
Participants with active or chronic corneal disorders, history of corneal transplant, keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulcer, other active eye disorders, and any clinically significant corneal disorders.
Participants underwent major surgery within 4 weeks before the first dose; Participants received bone marrow or extensive radiotherapy within 4 weeks before the first dose; received local radiotherapy within 2 weeks before the first dose of the study drug; Participants continuously received systemic corticosteroids; Participants received standard chemotherapy, biological therapy, immunotherapies, any investigational medicinal product (IMP) and other systemic anti-tumor treatments within 4 weeks before the first dose.
Participants with active malignant tumors within the past 2 years.
Trial design
Design model
Single group
Treatments tested in this trial
HDM2020
DrugFGFR2b-ADC
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: HDM 2020Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 period2
Incidence of Treatment-Emergent Adverse Events
Incidence rates of adverse events (AE), serious adverse events (SAE)
Time frame
Estimated 1 yearSecondary outcomes
1
Time to peak (Tmax)
Tmax of HDM2020, total antibody, and exatecan will be measured
Time frame
Estimated 1 year2
Half-life time (t1/2)
t1/2 of HDM2020, total antibody, and exatecan will be measured
Time frame
Estimated 1 year3
Peak Plasma Concentration (Cmax)
Cmax of HDM2020, total antibody, and exatecan will be measured
Time frame
Estimated 1 year4
Area under the plasma concentration versus time curve (AUC)
AUC of HDM2020, total antibody, and exatecan will be measured
Time frame
Estimated 1 yearOther outcomes
1
Target expression levels
Target expression levels and their correlation with antitumor activity.
Time frame
Estimated 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov