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.
Target population are patients with advanced solid tumors .
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
63
ADC drug targeting EGFR and HER3
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGMaximal tolerance dose (MTD) of HDM2024
The MTD is defined as the dose level at which the estimated toxicity probability is closest to the target toxicity rate during the Dose-limiting toxicity (DLT) observation period of the dose escalation stage.
Time frame: DLT will be evaluated on 21 days of observation period
Determination of the Recommended Phase 2 dose (RP2D)
Time frame: Approximately 1 years
Incidence and severity of Treatment-Emergent Adverse Events
Incidence rates of adverse events (AE), serious adverse events (SAE)per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v6.0.
Time frame: Approximately 1 years
Time to peak (Tmax) of HDM2024
Tmax of HDM2024, total antibody, and exatecan will be measured
Time frame: Approximately 1 years
Half-life time (t1/2) of HDM2024
t1/2 of HDM2024, total antibody, and exatecan will be measured
Time frame: Approximately 1year
Peak Plasma Concentration (Cmax) of HDM2024
Cmax of HDM2024, total antibody, and exatecan will be measured
Time frame: Approximately 1 year
Area under the plasma concentration versus time curve (AUC) of HDM2024
AUC of HDM2024, total antibody, and exatecan will be measured
Time frame: approximately 1 year
Objective response rate (ORR)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ORR assessed based on RECIST v1.1 criterion
Time frame: Approximately 1 year
Disease control rate (DCR)
DCR assessed based on RECIST v1.1 criterion
Time frame: Approximately 1 year
Progression-free survival (PFS)
PFS assessed based on RECIST v1.1 criterion
Time frame: Approximately 1year
Overall survival (OS)
OS of 6-months and 12-months
Time frame: Approximately 1 year