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Not yet recruiting NCT07667842

Study of D3L-002 in Subjects With Advanced Solid Tumors

Phase I Interventional Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: D3L-002.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

Interventions

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

Primary outcome measures

  • 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)]
  • Change from Baseline in Hemoglobin [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in White Blood Cell Count [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Platelet Count [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Alanine Aminotransferase (ALT) [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Aspartate Aminotransferase (AST) [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Creatinine [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Urine Protein [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Urine Glucose [Time frame: From baseline through 30 days after the last dose]
  • Change from Baseline in Urine Blood [Time frame: From baseline through 30 days after the last dose]
Secondary outcome measures (10)
  • Pharmacokinetics: Maximum Plasma Concentration (Cmax) [Time frame: From Day 1 through End of Treatment (up to approximately 6 months)]
  • Pharmacokinetics: Minimum (Trough) Concentration (Ctrough) [Time frame: From Day 1 through End of Treatment (up to approximately 6 months)]
  • Pharmacokinetics: Time to Maximum Concentration (Tmax) [Time frame: From Day 1 through End of Treatment (up to approximately 6 months)]
  • Pharmacokinetics: Terminal Half-Life (t½) [Time frame: From Day 1 through End of Treatment (up to approximately 6 months)]
  • Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) [Time frame: From Day 1 through End of Treatment (up to approximately 6 months)]
  • Immunogenicity: Incidence of Anti-Drug Antibodies (ADA) [Time frame: From baseline through Safety Follow-up Visit (up to 30 days after last dose)]
  • Objective Response Rate (ORR) [Time frame: From first dose through disease progression or end of study (up to approximately 12 months)]
  • Duration of Response (DOR) [Time frame: From first documented response until disease progression or death (up to approximately 12 months)]
  • Disease Control Rate (DCR) [Time frame: From first dose through disease assessment period (up to approximately 6 months)]
  • Progression-Free Survival (PFS) [Time frame: From first dose until disease progression or death (up to approximately 12 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07667842 · D3L-002-100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗