Study of D3L-002 in Subjects With Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorD3 Bio (Wuxi) Co., Ltd
About this trial
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 criteria
Qualifiers
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
Disqualifiers
Prior anti-TIGIT or anti-PVRIG therapy
Recent anticancer therapy without adequate washout
Active or uncontrolled illness
Interstitial lung disease/pneumonitis
Trial design
Treatments tested in this trial
- D3L-002
Treatment groups
24 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov