This is a first-in-human, multicenter, open-label, single-arm, dose-escalation Phase 1 study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of D3L-002 monotherapy in subjects with advanced solid tumors. D3L-002 will be administered as an intravenous infusion every 3 weeks (Q3W) in 21-day cycles. Approximately 24 subjects will be enrolled. Dose escalation will follow a Bayesian Optimal Interval (BOIN) design to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Timeframe: From first dose through 30 days after the last dose (Safety Follow-up Visit)
Change from Baseline in Hemoglobin
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in White Blood Cell Count
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Platelet Count
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Alanine Aminotransferase (ALT)
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Aspartate Aminotransferase (AST)
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Creatinine
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Urine Protein
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Urine Glucose
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Urine Blood
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Systolic Blood Pressure
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Diastolic Blood Pressure
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Heart Rate
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Respiratory Rate
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Body Temperature
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Physical Examination Findings
Timeframe: From baseline through 30 days after the last dose
Change from Baseline in Electrocardiogram (ECG) Parameters (QT Interval, PR Interval, QRS Duration, Heart Rate)
Timeframe: From baseline through 30 days after the last dose
Determination of Maximum Tolerated Dose (MTD)
Timeframe: Cycle 1 (Day 1 through Day 21)
Determination of Recommended Phase 2 Dose (RP2D)
Timeframe: Through end of dose-escalation phase (approximately up to 3 months following last subject's first dose)