Study of D3L-002 in Subjects With Advanced Solid Tumors

Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)

Incidence, nature, and severity of TEAEs and TRAEs assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

Time frame: From first dose through 30 days after the last dose (Safety Follow-up Visit)

Change from Baseline in Hemoglobin

Change from baseline in hemoglobin (g/dL)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in White Blood Cell Count

Change from baseline in white blood cell count (×10\^9/L)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Platelet Count

Change from baseline in platelet count (×10\^9/L)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Alanine Aminotransferase (ALT)

Change from baseline in alanine aminotransferase (ALT, U/L)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Aspartate Aminotransferase (AST)

Change from baseline in aspartate aminotransferase (AST, U/L)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Creatinine

Change from baseline in creatinine (mg/dL)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Urine Protein

Change from baseline in urine protein (semi-quantitative or mg/dL per local laboratory standard)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Urine Glucose

Change from baseline in urine glucose (semi-quantitative per local laboratory standard)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Urine Blood

Change from baseline in urine blood (semi-quantitative per local laboratory standard)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Systolic Blood Pressure

Change from baseline in systolic blood pressure (mmHg)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Diastolic Blood Pressure

Change from baseline in diastolic blood pressure (mmHg)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Heart Rate

Change from baseline in heart rate (beats per minute)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Respiratory Rate

Change from baseline in respiratory rate (breaths per minute)

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Body Temperature

Change from baseline in body temperature (°C or °F).

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Physical Examination Findings

Evaluation of clinically significant changes from baseline in physical examination findings across body systems (e.g., cardiovascular, respiratory, neurological), as assessed by the investigator and categorized as normal or abnormal.

Time frame: From baseline through 30 days after the last dose

Change from Baseline in Electrocardiogram (ECG) Parameters (QT Interval, PR Interval, QRS Duration, Heart Rate)

Evaluation of clinically significant changes from baseline in 12 lead electrocardiogram (ECG) parameters, including QT interval (milliseconds), PR interval (milliseconds), QRS duration (milliseconds), and heart rate (beats per minute).

Time frame: From baseline through 30 days after the last dose

Determination of Maximum Tolerated Dose (MTD)

Determination of MTD based on dose-limiting toxicities (DLTs) occurring during the first cycle (21 days); MTD defined as the dose with estimated DLT rate closest to 30% using a BOIN design

Time frame: Cycle 1 (Day 1 through Day 21)

Determination of Recommended Phase 2 Dose (RP2D)

Determination of RP2D based on the totality of safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy data

Time frame: Through end of dose-escalation phase (approximately up to 3 months following last subject's first dose)