Study of D3L-002 in Subjects With Advanced Solid Tumors
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
D3 Bio (Wuxi) Co., Ltd
24 participants
Jul 14, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria18
- 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
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Interventions
D3L-002 is an investigational anti-TIGIT/anti-PVRIG bispecific antibody administered as an intravenous infusion every 3 weeks (Q3W).
Locations(6)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07667842