Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Phase 1: Number of Participants With Adverse Event (AEs) and Serious Adverse Events (SAEs) and Adverse Events Leading to Discontinuation |
|
Baseline up to 30 months |
|
Primary |
Phase 1: Number of Participants With Dose Limiting Toxicity (DLT) |
|
At the end of Cycle 1 (Each cycle is of 21 Days) |
|
Primary |
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. |
Baseline up to 24 months |
|
Primary |
Phase 1: Number of Participants With Clinically Significant Abnormalities in Vital Signs |
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. |
Baseline up to 24 months |
|
Primary |
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. |
Baseline up to 24 months |
|
Primary |
Phase 1: Number of Participants With Clinically Significant Abnormalities in 12-lead Electrocardiogram (ECG) |
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. |
Baseline up to 24 months |
|
Primary |
Phase 2: Objective Response Rate (ORR) |
Objective response rate (ORR), defined as the percentage of participants with a best overall response (BOR) of either a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for solid tumors by investigators. |
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) |
|
Secondary |
Phase 1: Objective Response Rate (ORR) |
Objective response rate (ORR), defined as the percentage of participants with a BOR of either a complete response (CR) or partial response (PR), per RECIST version 1.1 for solid tumors by investigators. |
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) |
|
Secondary |
Phase 1 and 2: Duration of Response (DOR) |
|
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 56 months) |
|
Secondary |
Phase 1 and 2: Disease Control Rate (DCR) |
DCR will be defined similarly to ORR but also including stable disease (SD) in the categorization of response (i.e, RECIST response of either CR, PR, or SD). |
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 56 months) |
|
Secondary |
Phase 1 and 2: Time to Response (TTR) |
|
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 56 months) |
|
Secondary |
Phase 1 and 2: Time to Progression (TTP) |
|
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 56 months) |
|
Secondary |
Phase 1 and 2: Durable Clinical Benefit (DCB) |
DCB will be defined similarly to DCR but additionally specifying that the disease control be achieved for at least 12 weeks consecutive (i.e, RECIST response of CR, PR or SD for greater than or equal to [>=] 12 weeks consecutive). |
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 56 months) |
|
Secondary |
Phase 1 and 2: Progression-Free Survival (PFS) |
|
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 56 months) |
|
Secondary |
Phase 1 and 2: Overall survival (OS) |
|
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 56 months) |
|
Secondary |
Phase 1 and 2: Maximum Observed Serum Concentration (Cmax) of EU101 |
Cmax is defined as maximum observed serum concentration. |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Trough Serum Concentration (Ctrough) of EU101 |
Ctrough is steady-state pre-dose concentration. |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Time to Reach Maximum Observed Serum Concentration (Tmax) of EU101 |
Tmax is defined as time to reach maximum observed serum concentration. |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of EU101 |
AUC0-24 is defined as the area under the serum concentration versus time curve from time zero (pre-dose) to 24 hours post-dose (0 to 24). |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of EU101 |
AUC0-last is defined as area under the serum concentration time-curve from time zero to the time of last measured concentration. |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Area Under the Serum Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of EU101 |
AUCinf is defined as area under the serum concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf). |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Elimination Half-Life Time (T1/2) of EU101 |
T1/2 is defined as plasma decay half-life is the time measured for the serum concentration to decrease by one half. |
Cycle 1: Pre-dose up to 336 hours post-dose; Cycle 2: 504 hours post-dose; Cycle 3: Pre-dose (Each cycle is of 21 days)] |
|
Secondary |
Phase 1 and 2: Apparent Volume of Distribution (Vd/F) of EU101 |
Vd/F is defined as volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired serum concentration of a drug. |
Baseline (Day 1) |
|
Secondary |
Phase 1 and 2: Apparent Oral Clearance of (CL/F) of EU101 |
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. |
Baseline (Day 1) |
|
Secondary |
Phase 1 and 2: Mean Residence Time (MRT) of EU101 |
MRT is defined as AUMC(0 - inf) divided by AUC(0 - inf), where AUMC(0 - inf) is the area under the first moment curve from time 0 extrapolated to infinite time. |
Baseline (Day 1) |
|
Secondary |
Phase 1 and 2: Renal clearance (CLr) of EU101 |
CLr is defined as renal clearance is the volume of plasma completely cleared of EU101 by the kidneys per unit time. |
Baseline (Day 1) |
|
Secondary |
Phase 1 and 2: Number of Participants with Positive Antidrug Antibodies (ADA) |
The immunogenic potential of EU101 will be assessed by summarizing the number of participants who develop detectable antidrug antibody (ADAs). |
Baseline up to 56 months |
|
Secondary |
Phase 2: Number of Participants With AEs and SAEs by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
|
Time from first dose of study treatment up to 30 months |
|