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Study of D3L-002 in Subjects With Advanced Solid Tumors

NCT07667842 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-06-25

No results posted yet for this study

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

Interventions

DRUG

D3L-002

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

Sponsors & Collaborators

  • D3 Bio (Wuxi) Co., Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-18
Primary Completion
2027-11-12
Completion
2028-02-12

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07667842 on ClinicalTrials.gov