Phase 1 (dose escalation) of this study will evaluate: The safety and tolerability of EU103 treatment are evaluated for patients with advanced or metastatic solid tumors who have failed standard therapy to determine the maximum tolerated dose and recommended Phase 2 dose. And preliminary efficacy (tumor response), The pharmacokinetic characteristics are evaluated, and changes are investigated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
EU103 will be administered via intravenous infusion.
Asan Medical Center
Seoul, South Korea
RECRUITINGSamsung Seoul Hospital
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGAdverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events
Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation
Time frame: Baseline up to 30 months
Dose Limiting Toxicity (DLT)
Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (Each cycle is of 21 Days)
Phase 1:Number of Participants With Clinically Significant Abnormalities in Laboratory Parameters
Laboratory assessments include hematology, serum chemistry, other blood tests, coagulation, and urine analysis. Number of participants with clinically significant abnormalities will be reported.
Time frame: Time Frame: Baseline up to 24 months
Number of participants with clinically significant abnormalities
Vital signs will include body temperature, pulse rate, and systolic and diastolic blood pressure measurements. Number of participants with clinically significant abnormalities will be reported.
Time frame: Time Frame: Baseline up to 24 months
Phase 1:Number of Participants With Clinically Significant Abnormalities in Physical Examination
Physical examination will include head, eyes, ears, nose and throat; heart; lungs; abdomen; skin; cervical and axillary lymph nodes; and neurological and musculoskeletal systems. Number of participants with clinically significant abnormalities will be reported.
Time frame: Time Frame: Baseline up to 24 months
Phase 1:Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG)Physical Examination
ECG parameters included heart rhythm, pulse rate intervals, QRS, QT intervals, RR intervals and corrected QT(QTc) intervals. Number of participants with clinically significant abnormalities will be reported.
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Time frame: Time Frame: Baseline up to 24 months
Phase 1:Production of anti-drug antibodies (ADAs)
The number of subjects, percentage, and Exact 95% confidence interval for subjects who are anti-drug antibody (ADA) positive at each measurement time point compared to before administration of investigational drugs are presented for each dose level.
Time frame: Time Frame: Baseline up to 30 months
Phase 1:Objective response rate (ORR)
Proportion of subjects whose best overall response (BOR) is confirmed as complete response (CR) or partial response (PR)
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)
Phase 1:Duration of response (DoR)
Time from achievement of tumor response (CR or PR) to the time of confirmed progressive disease (PD)
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)
Phase 1:Disease control rate (DCR)
Proportion of subjects whose BOR is confirmed as CR, PR, or stable disease (SD: 6 weeks or longer)
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)
Phase 1:Time to response (TTR)
Time from the date of the investigational product administration to the time of confirmed objective response (CR or PR)
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)
Phase 1:Time to progression (TTP)
Time from the date of the investigational product administration to the time of PD
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)
Phase 1:Progression-free survival (PFS)
Time from the date of the investigational product administration to the time of PD or death from any cause, whichever occurs first
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)
Phase 1:Overall survival (OS)
Time from the date of the investigational product administration to death due to any cause
Time frame: Time from first dose of study treatment assessed until disease progression, death, withdrawal of consent, physician's decision, start of new anticancer therapy, or end of study, whichever occurs first (approximately for 24 months)