Study of D3L-002 in Subjects With Advanced Solid Tumors

Starting soon · Phase 1

Conditions studied: Advanced Solid Tumor

In brief

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).

Key facts

Study ID

NCT07667842

Run by

D3 Bio (Wuxi) Co., Ltd

People needed

24

Starts

2026-07-18

Expected to finish

2028-02-12

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Pregnancy or breastfeeding
• Hypersensitivity to study drug
• Investigator-determined unsuitability

Full record on ClinicalTrials.gov

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