Study of D3L-002 in Subjects With Advanced Solid Tumors

Sponsor
D3 Bio (Wuxi) Co., Ltd
Study ID
NCT07667842
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • Advanced Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

First listed
Jun 25, 2026
Start date
Jul 18, 2026
Status verified
Jun 2026
Primary completion
Nov 12, 2027
Completion
Feb 12, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: D3L-002
    Dose Escalation * Cohort 1 (starting dose) * Cohort 2 * Cohort 3 * Cohort 4

Primary Outcome Measure

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) ]

Central Contacts

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