Study of D3L-002 in Subjects With Advanced Solid Tumors

NCT07667842 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: D3L-002-100
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (19)

• 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

  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)

  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)

  From baseline through 30 days after the last dose

• Change from Baseline in Platelet Count

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

  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)

  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)

  From baseline through 30 days after the last dose

• Change from Baseline in Creatinine

  Change from baseline in creatinine (mg/dL)

  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)

  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)

  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)

  From baseline through 30 days after the last dose

• Change from Baseline in Systolic Blood Pressure

  Change from baseline in systolic blood pressure (mmHg)

  From baseline through 30 days after the last dose

• Change from Baseline in Diastolic Blood Pressure

  Change from baseline in diastolic blood pressure (mmHg)

  From baseline through 30 days after the last dose

• Change from Baseline in Heart Rate

  Change from baseline in heart rate (beats per minute)

  From baseline through 30 days after the last dose

• Change from Baseline in Respiratory Rate

  Change from baseline in respiratory rate (breaths per minute)

  From baseline through 30 days after the last dose

• Change from Baseline in Body Temperature

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

  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.

  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).

  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

  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

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

Secondary Outcomes (10)

• Pharmacokinetics: Maximum Plasma Concentration (Cmax)

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

• Pharmacokinetics: Minimum (Trough) Concentration (Ctrough)

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

• Pharmacokinetics: Time to Maximum Concentration (Tmax)

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

• Pharmacokinetics: Terminal Half-Life (t½)

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

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

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

Study Arms (1)

D3L-002

EXPERIMENTAL

Dose Escalation * Cohort 1 (starting dose) * Cohort 2 * Cohort 3 * Cohort 4

Drug: D3L-002

Interventions

D3L-002 DRUG

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

D3L-002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• D3 Bio (Wuxi) Co., Ltd: lead

Central Study Contacts

Medical Director

CONTACT

+86 21 61635900; D3bio_CT@d3bio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 25, 2026
• Study Start: July 18, 2026
• Primary Completion (Estimated): November 12, 2027
• Study Completion (Estimated): February 12, 2028
• Last Updated: June 25, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share