Study of D3L-002 in Subjects With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

D3L-002: D3L-002 is an investigational anti-TIGIT/anti-PVRIG bispecific antibody administered as an intravenous infusion every 3 weeks (Q3W).

Study summary

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).

Eligibility

Primary outcome measure(s)

• Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) — From first dose through 30 days after the last dose (Safety Follow-up Visit)
  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
• Change from Baseline in Hemoglobin — From baseline through 30 days after the last dose
  Change from baseline in hemoglobin (g/dL)
• Change from Baseline in White Blood Cell Count — From baseline through 30 days after the last dose
  Change from baseline in white blood cell count (×10\^9/L)
• Change from Baseline in Platelet Count — From baseline through 30 days after the last dose
  Change from baseline in platelet count (×10\^9/L)
• Change from Baseline in Alanine Aminotransferase (ALT) — From baseline through 30 days after the last dose
  Change from baseline in alanine aminotransferase (ALT, U/L)
• Change from Baseline in Aspartate Aminotransferase (AST) — From baseline through 30 days after the last dose
  Change from baseline in aspartate aminotransferase (AST, U/L)
• Change from Baseline in Creatinine — From baseline through 30 days after the last dose
  Change from baseline in creatinine (mg/dL)
• Change from Baseline in Urine Protein — From baseline through 30 days after the last dose
  Change from baseline in urine protein (semi-quantitative or mg/dL per local laboratory standard)
• Change from Baseline in Urine Glucose — From baseline through 30 days after the last dose
  Change from baseline in urine glucose (semi-quantitative per local laboratory standard)
• Change from Baseline in Urine Blood — From baseline through 30 days after the last dose
  Change from baseline in urine blood (semi-quantitative per local laboratory standard)
• Change from Baseline in Systolic Blood Pressure — From baseline through 30 days after the last dose
  Change from baseline in systolic blood pressure (mmHg)
• Change from Baseline in Diastolic Blood Pressure — From baseline through 30 days after the last dose
  Change from baseline in diastolic blood pressure (mmHg)
• Change from Baseline in Heart Rate — From baseline through 30 days after the last dose
  Change from baseline in heart rate (beats per minute)
• Change from Baseline in Respiratory Rate — From baseline through 30 days after the last dose
  Change from baseline in respiratory rate (breaths per minute)
• Change from Baseline in Body Temperature — From baseline through 30 days after the last dose
  Change from baseline in body temperature (°C or °F).
• Change from Baseline in Physical Examination Findings — From baseline through 30 days after the last dose
  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.
• Change from Baseline in Electrocardiogram (ECG) Parameters (QT Interval, PR Interval, QRS Duration, Heart Rate) — From baseline through 30 days after the last dose
  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).
• Determination of Maximum Tolerated Dose (MTD) — Cycle 1 (Day 1 through Day 21)
  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
• Determination of Recommended Phase 2 Dose (RP2D) — Through end of dose-escalation phase (approximately up to 3 months following last subject's first dose)
  Determination of RP2D based on the totality of safety, tolerability, pharmacokinetic, pharmacodynamic, and preliminary efficacy data

Trial sites (6)

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