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NCT Number: NCT07667842

Study of D3L-002 in Subjects With Advanced Solid Tumors

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).

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written informed consent and comply with study procedures
  • Age ≥18 years
  • Histologically confirmed metastatic or locally advanced incurable solid tumor that has progressed after ≥1 line of therapy or has no available standard treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • Adequate organ function (hematologic, hepatic, renal)
  • Life expectancy ≥12 weeks
  • Willingness to provide tumor tissue (if available) and blood samples
  • Agreement to use effective contraception
  • Negative pregnancy test for participants of childbearing potential

Exclusion criteria

  • Prior anti-TIGIT or anti-PVRIG therapy
  • Recent anticancer therapy without adequate washout
  • Active or uncontrolled illness
  • Interstitial lung disease/pneumonitis
  • Active Central Nervous System (CNS) disease
  • Uncontrolled effusions
  • Unresolved ≥Grade 2 toxicities
  • Severe prior immunotherapy-related toxicity
  • Active autoimmune disease
  • Active infection
  • Active hepatitis B/C or HIV
  • Recent malignancy (exceptions apply)
  • Significant cardiovascular disease
  • Immunosuppressive therapy within 14 days
  • Live vaccine within 30 days
  • Pregnancy or breastfeeding
  • Hypersensitivity to study drug
  • Investigator-determined unsuitability

Treatment and study plan

D3L-002

Drug

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

Primary outcomes

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

    Time frame: 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

  2. Change from Baseline in Hemoglobin

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

    Change from baseline in hemoglobin (g/dL)

  3. Change from Baseline in White Blood Cell Count

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

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

  4. Change from Baseline in Platelet Count

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

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

  5. Change from Baseline in Alanine Aminotransferase (ALT)

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

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

  6. Change from Baseline in Aspartate Aminotransferase (AST)

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

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

  7. Change from Baseline in Creatinine

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

    Change from baseline in creatinine (mg/dL)

  8. Change from Baseline in Urine Protein

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

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

  9. Change from Baseline in Urine Glucose

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

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

  10. Change from Baseline in Urine Blood

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

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

  11. Change from Baseline in Systolic Blood Pressure

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

    Change from baseline in systolic blood pressure (mmHg)

  12. Change from Baseline in Diastolic Blood Pressure

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

    Change from baseline in diastolic blood pressure (mmHg)

  13. Change from Baseline in Heart Rate

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

    Change from baseline in heart rate (beats per minute)

  14. Change from Baseline in Respiratory Rate

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

    Change from baseline in respiratory rate (breaths per minute)

  15. Change from Baseline in Body Temperature

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

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

  16. Change from Baseline in Physical Examination Findings

    Time frame: 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.

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

    Time frame: 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).

  18. Determination of Maximum Tolerated Dose (MTD)

    Time frame: 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

  19. Determination of Recommended Phase 2 Dose (RP2D)

    Time frame: 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

Secondary outcomes

  1. Pharmacokinetics: Maximum Plasma Concentration (Cmax)

    Time frame: From Day 1 through End of Treatment (up to approximately 6 months)

    Maximum observed serum concentration of D3L-002 following intravenous administration

  2. Pharmacokinetics: Minimum (Trough) Concentration (Ctrough)

    Time frame: From Day 1 through End of Treatment (up to approximately 6 months)

    Predose serum concentration of D3L-002 at steady state

  3. Pharmacokinetics: Time to Maximum Concentration (Tmax)

    Time frame: From Day 1 through End of Treatment (up to approximately 6 months)

    Time from dosing to maximum observed serum concentration of D3L-002

  4. Pharmacokinetics: Terminal Half-Life (t½)

    Time frame: From Day 1 through End of Treatment (up to approximately 6 months)

    Terminal elimination half-life of D3L-002 calculated from serum concentration-time data

  5. Pharmacokinetics: Area Under the Concentration-Time Curve (AUC)

    Time frame: From Day 1 through End of Treatment (up to approximately 6 months)

    Area under the serum concentration-time curve of D3L-002

  6. Immunogenicity: Incidence of Anti-Drug Antibodies (ADA)

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

    Incidence of subjects with detectable anti-drug antibodies to D3L-002

  7. Objective Response Rate (ORR)

    Time frame: From first dose through disease progression or end of study (up to approximately 12 months)

    Proportion of subjects achieving confirmed complete response (CR) or partial response (PR) per RECIST version 1.1 as assessed by investigators

  8. Duration of Response (DOR)

    Time frame: From first documented response until disease progression or death (up to approximately 12 months)

    Time from first documented objective response (CR or PR) to disease progression or death

  9. Disease Control Rate (DCR)

    Time frame: From first dose through disease assessment period (up to approximately 6 months)

    Proportion of subjects achieving CR, PR, or stable disease (SD) lasting at least 6 weeks per RECIST v1.1

  10. Progression-Free Survival (PFS)

    Time frame: From first dose until disease progression or death (up to approximately 12 months)

    Time from first dose of D3L-002 to disease progression per RECIST v1.1 or death from any cause

Study contacts

Contact information is provided by the study sponsor or research team.

Medical Director

CONTACT

[email protected]

+86 21 61635900

Sponsors and collaborators

Lead sponsor

D3 Bio (Wuxi) Co., Ltd

Industry

Registry information

Official study title

A Phase 1, Open-label, Dose-Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of D3L-002 (an Anti-TIGIT/Anti-PVRIG Bispecific Antibody) Monotherapy in Subjects With Advanced Solid Tumors

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 25, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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